[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"recurrent-acute-myeloid-leukemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:recurrent-acute-myeloid-leukemia":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,36,0,25,[9,43,70,94,125,149,174,194,211,235,255,278,296,316,327,367,386,404,430,467,488,512,538,556,578],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100053726","phase-3-xylitol-dental-wipes-for-the-reduction-of-bloodstream-infection-risk-in-children-with-acute-myeloid-leukemia-100053726",false,"NCT07022678","Xylitol Dental Wipes for the Reduction of Bloodstream Infection Risk in Children With Acute Myeloid Leukemia","A Randomized Double-Blinded Trial of Xylitol Dental Wipes for the Prophylaxis of Bloodstream Infections From Oral Organisms in Pediatric Patients With Acute Myeloid Leukemia","Inclusion Criteria:\n\n* Patient must be ≥ 1 year to ≤ 25 years old at enrollment.\n* Patient must have a diagnosis of AML according to the 2016 World Health Organization classification with or without extramedullary disease. Patients with either newly diagnosed or relapsed AML are eligible as long as they meet the planned treatment criteria.\n* Patient should be planned to receive at least 2 consecutive cycles of myelosuppressive chemotherapy. Each cycle must:\n\n  * Contain IV cytarabine (liposomal formulations allowed), and\n  * The duration of severe neutropenia should be expected to be ≥ 7 days. Hematopoietic stem cell transplantation (HSCT) conditioning cannot count as one of the two required planned cycles.\n\nNote: Patients do not need to be co-enrolled on an upfront AML treatment protocol study, but co-enrollment is permitted.\n\n* Minimum of one visible or erupted tooth.\n* Agree to avoid xylitol containing gum or toothpaste during intervention period.\n* All patients and\u002For their parents or legal guardians must sign a written informed consent.\n* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met.\n\nExclusion Criteria:\n\n* Patients with Down syndrome-associated AML.\n* Prior therapy: Prior radiation treatment for cancer of oral cavity, head or neck in past 6 months per study participant's medical record.\n* Patients with known history of allergy to xylitol.\n* Patients with known history of allergy to grapes or grape flavoring.\n* Patients who are actively being treated for an oral organism related blood stream infection.\n* Patients for whom the practitioner believes are unable to comply with use of oral dental wipes.","ALL","1 Year","25 Years",{"count":21,"type":22},556,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","This phase III trial compares the effect of xylitol dental wipes to dental wipes without xylitol for the reduction of bloodstream infection in children with acute myeloid leukemia (AML). Xylitol is a naturally occurring sugar compound found in fruits and vegetables. Xylitol has been shown to limit the growth of bacteria in the mouth, and to reduce cavities, plaque on the teeth, and inflammation of the gums. Treatment for AML includes chemotherapy. Patients receiving chemotherapy for AML have a risk of developing bloodstream infections. Bloodstream infections can make patients very sick, can contribute to delays in treatment, and can even cause death. In AML patients, bacteria or fungus (yeast) can sometimes enter the bloodstream from the mouth. Using xylitol dental wipes may help to reduce bloodstream infections in children being treated for AML.",[28,29],"Acute Myeloid Leukemia","Recurrent Acute Myeloid Leukemia","RECRUITING","2026-07-10",{"date":33,"type":34},"2026-07-13","ACTUAL",{"date":36,"type":34},"2026-05-26",{"date":38,"type":22},"2033-01-15",{"name":40,"class":41},"Children's Oncology Group","NETWORK",24,{"id":44,"slug":45,"hasResults":12,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":12,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":69},"100553947","phase-1-dr-18-to-prevent-or-treat-acute-myeloid-leukemia-or-myelodysplastic-syndrome-relapse-after-hematopoietic-cell-transplantation-the-dr-dream-trial-100553947","NCT06492707","DR-18 to Prevent or Treat Acute Myeloid Leukemia or Myelodysplastic Syndrome Relapse After Hematopoietic Cell Transplantation, the DR. DREAM Trial","Decoy-Resistant Interleukin-18 (DR-18) for Relapse, Pre-emptive Treatment or Prophylaxis After Allogeneic Hematopoietic Cell Transplantation in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome (DR. DREAM)","Inclusion Criteria:\n\n* ≥ 18 years of age (no upper age limit)\n* The most recent HCT was from a 10\u002F10 human leukocyte antigen (HLA)-matched related or unrelated donor (assessed at HLA-A, B, C, DR, DQ)\n* Evidence of blood count recovery at any time post-HCT defined as absolute neutrophil count (ANC) ≥ 0.5 x 10\\^9\u002FL for ≥ 3 consecutive days and platelets ≥ 30 x 10\\^9\u002FL (independent of granulocyte colony-stimulating factor \\[G-CSF\\] or platelet transfusions for 5 days). (Blood count recovery may not be sustained.)\n* Absent, stable or reducing immune suppression in the preceding 4 weeks without GvHD flares\n* Karnofsky performance status (KPS) ≥ 80%\n* Agrees to use a suitable method of contraception during study treatment and for 4 months after the last dose of DR-18\n* Capable of providing informed consent\n* GROUP 1: Documented persistent or recurrent measurable residual AML or MDS after HCT, defined as bone marrow blasts \\\u003C 5% by morphology (unless suspected to be regenerative) and malignant bone marrow blasts \\\u003C 5% by flow cytometry.\n\n  * Note: MRD (\\\u003C 5% malignant blasts) must be detected with flow cytometry testing at University of Washington Medical Center (UWMC)\u002FFred Hutchinson Cancer Center (Fred Hutch) clinical laboratory\n* GROUP 1: Absence of circulating malignant blasts detected by the complete blood count (CBC)\n* GROUP 1: Absence of extramedullary disease\n* GROUP 1: Post-HCT restaging never detected overt relapse or disease persistence, defined as ≥ 5% (non-regenerative) blasts by morphology or flow cytometry, or circulating malignant blasts on CBC, or extramedullary disease\n* GROUP 1: At least 60 days have elapsed since the HCT donor cell infusion (HCT day 0). (There is no upper limit to the time elapsed since HCT.)\n* GROUP 1: No Food and Drug Administration (FDA)-approved targeted therapy for the participant's AML or MDS is available, or if such therapy is available, that class of drugs previously failed for the participant or the participant was intolerant of the therapy\n* GROUP 2: HCT is with post-transplant cyclophosphamide or other form of in vivo or ex-vivo T cell depletion\n* GROUP 2: Informed consent was signed pre-HCT or latest day 28 post-HCT. (Treatment may start as early as 30 days post-HCT.)\n* GROUP 2-ONLY IF AML BY WORLD HEALTH ORGANIZATION (WHO) OR INTERNATIONAL CONSENSUS CLASSIFICATION (ICC) 2022 CRITERIA: Pre-HCT bone marrow shows residual leukemia by flow cytometry (MRD or overt disease with ≥ 5% blasts)\n* GROUP 2-ONLY IF AML BY WHO OR ICC 2022 CRITERIA: The participant had at least 1 course of intensive induction chemotherapy or 2 cycles of hypomethylating therapy with venetoclax or 4 cycles of hypomethylating therapy prior to HCT\n* GROUP 2-ONLY IF MDS BY WHO OR ICC 2022 CRITERIA: Any one of the following high-risk features was detected in the pre-HCT disease course:\n\n  * International Prognostic Scoring System-MDS (IPSS-M) score \"very high\" risk\n  * TP53 pathogenic or likely pathogenic mutation with variant allele frequency (VAF) ≥ 50%\n  * TP53 pathogenic or likely pathogenic mutation with VAF \\\u003C 50% and complex cytogenetics or 5q or 7q cytogenetic abnormalities\n  * Biallelic TP53 mutations\n  * The patient had at least 1 course of intensive induction chemotherapy or 2 cycles of hypomethylating therapy with venetoclax or 4 cycles of hypomethylating therapy and the pre-HCT bone marrow evaluation still shows \\> 5% malignant blasts by flow cytometry\n\nExclusion Criteria:\n\n* Cellular immunotherapy or new targeted therapy in the 4 weeks prior to the first DR-18 injection\n* History of grade 3 or 4 acute GvHD after the most recent HCT\n* History of moderate or severe chronic GvHD after the most recent HCT\n* Active acute or chronic GvHD or other immunologic phenomenon (e.g., immune cytopenias, cryptogenic immunologic pneumonia) in last month requiring systemic therapy (Hydrocortisone or prednisone for adrenal insufficiency at ≤ 10 mg\u002Fday prednisone-equivalent is permitted.)\n* Active moderate-severe thrombotic microangiopathy (TMA) as evidenced by any of the following: \\> 10 schistocytes per high-power field, or required anti-C5 or other anti-complement therapy for TMA in the prior 4 weeks, any of the following manifestations if attributed to TMA in the prior 4 weeks: hypertension, worsening or new renal insufficiency, ≥ 2+ proteinuria, hematochezia, seizure, transient or ongoing neurologic deficits\n* Renal insufficiency: Estimated glomerular filtration rate (eGFR) (calculated per the performing laboratory's standard formula) or measured 24 hour (hr.) creatinine clearance \\\u003C 30 mL\u002Fmin\n* Hemodialysis in the prior 4 weeks\n* Major cardiac event requiring evaluation in the emergency room (ER) or hospitalization in the past 4 weeks\n* New York Heart Association (NYHA) class II or higher congestive heart failure (CHF) in the past 4 weeks\n* Uncontrolled cardiac arrhythmias, including atrial fibrillation\n* Left ventricular ejection fraction (LVEF) \\\u003C 35%. LVEF may be established with echocardiogram or MUGA scan, and left ejection fraction must be ≥ 35%\n* Liver dysfunction: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\> 5 x upper limit of normal (ULN) or bilirubin \\> 3 x ULN\n* Active uncontrolled infection. Note: Examples of controlled infections:\n\n  * Bacterial infection may be still requiring antibiotics at the time of enrollment, but clinical signs and symptoms of the infection should be improving. If the participant had bloodstream infection, negative blood cultures off antibiotics must be documented prior to initiating DR-18 treatment. For urinary tract infection, a repeat urine culture must be sterile prior to initiating DR-18. Radiographic improvement of bacterial pneumonia may lag behind clinical improvement so is not mandatory prior to DR-18 initiation\n  * Fungal infection may be still requiring antifungal medication at the time of enrollment, but evidence of clinical response to antifungal medication (such as regression of lesions on chest CT) must be available at the time of enrollment\n  * Asymptomatic shedding of respiratory viruses after cessation of antiviral therapy, or if not specifically treated with antiviral therapy, is permitted\n  * Cytomegalovirus (CMV) viremia or organ infection meeting institutional criteria for CMV treatment with antiviral therapy such as ganciclovir, valganciclovir or foscarnet must be on maintenance phase of treatment or must have completed treatment and must not be in the induction treatment phase at the time of enrollment. Low-level CMV viremia not meeting institutional criteria for antiviral therapy is permitted, including low-level viremia in patients receiving CMV prophylaxis with letermovir\n* Any of the following: Pulmonary dysfunction requiring supplemental oxygen, even intermittently, in the past 2 weeks; corrected diffusion capacity of the lung for carbon monoxide (DLCO) or forced expiratory volume in 1 second (FEV1) \\\u003C 60% predicted; bronchiolitis obliterans syndrome; prior diagnosis of idiopathic pulmonary fibrosis; prior diagnosis of drug-induced pneumonitis; cryptogenic organizing pneumonia under active treatment\n* Seizure in the past 4 weeks or significant underlying neurologic disease: Study participants must not have significant active underlying neurologic disease, such as Parkinson's disease, amyotrophic lateral sclerosis, multiple sclerosis, epilepsy, prior symptomatic ischemic or hemorrhagic stroke, or transient ischemic attack, unless approved by principal investigator (PI). Peripheral neuropathy related to diabetes or prior chemotherapy is acceptable\n* Other medical, social, or psychiatric factor that interferes with medical appropriateness and\u002For ability to comply with study, as determined by the PI\n* Known allergic reactions to any of the components of study treatments\n* Concurrent use of other investigational anti-cancer agents\n* Peripheral blood T cell chimerism \\\u003C 40%\n* Pregnant or breastfeeding","18 Years",{"count":52,"type":22},40,[54],"PHASE1","This phase I trial tests the safety, side effects and best dose of decoy-resistant interleukin-18 (DR-18) and how well it works in treating patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) that has come back after a period of improvement (relapsed) or that remains despite treatment (persistent) after hematopoietic cell transplantation (HCT). HCT is the only curative therapy for most forms of AML and MDS. However, relapse occurs in a third of patients and is the most common cause of death after HCT. DR-18, a variant of the human cytokine interleukin-18, binds to IL-18 binding probein (IL-18BP) and overcomes the inhibitory effect of the IL-18BP on IL-18, which may boost the body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving DR-18 may be safe, tolerable and\u002For effective in treating patient with relapsed or persistent AML or MDS after HCT.",[28,57,29,58],"Myelodysplastic Syndrome","Recurrent Myelodysplastic Syndrome","2026-06-24",{"date":61,"type":34},"2026-06-26",{"date":63,"type":34},"2024-09-23",{"date":65,"type":22},"2028-10-01",{"name":67,"class":68},"Fred Hutchinson Cancer Center","OTHER",1,{"id":71,"slug":72,"hasResults":12,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":12,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":23,"phases":79,"briefSummary":80,"conditions":81,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":93},"100546798","phase-1-eltanexor-and-venetoclax-in-relapsed-or-refractory-myelodysplastic-syndrome-and-acute-myeloid-leukemia-100546798","NCT06399640","Eltanexor and Venetoclax in Relapsed or Refractory Myelodysplastic Syndrome and Acute Myeloid Leukemia","Phase Ib Study of Eltanexor and Venetoclax in Relapsed or Refractory Myelodysplastic Syndrome and Acute Myeloid Leukemia","Inclusion Criteria:\n\n\\- Age \\>\u002F= 18 years at the time of signing the Informed Consent Form (ICF); must voluntarily sign an ICF; and must be able to meet all study requirements.\n\nFor Myelodysplastic Syndrome (MDS):\n\nMorphologically confirmed diagnosis of MDS with increased blasts (\\>\u002F= 5%), with a prior DNA methyltransferase inhibitor (DNMTi) treatment and progression after 2 cycles or stable disease after 4 cycles\n\nFor Acute Myeloid Leukemia (AML):\n\nMorphologically confirmed diagnosis of AML in accordance with WHO diagnostic criteria that is relapsed or refractory following \\>\u002F= 1 line(s) of therapy.\n\n* WBC must be less than 25,000\u002Ful prior to study start (hydroxyurea allowed).\n* A bone marrow aspirate must be performed, and tissue collected for entrance to the trial unless circulating blasts \\>\u002F= 5% in which case, peripheral blood can be used.\n* Eastern Cooperative Oncology Group Performance Status of 0 - 2.\n* Must have adequate hepatic and renal function as demonstrated by the following:\n\nALT(SGPT) and\u002For AST (SGOT) \\\u003C\u002F= 3x upper limit of normal (ULN); Direct bilirubin \\\u003C\u002F= 1.5 x ULN; or Total bilirubin \\\u003C\u002F= 2.5x ULN (known Gilbert's Syndrome as cause of elevated bilirubin is allowed); Calculated creatinine clearance \\> 50 ml\u002Fmin (per the Cockroft-Gault formula).\n\n\\- Willingness to abide by all study requirements, including contraception, maintenance of a pill diary, and acceptance of recommended supportive care medications.\n\nExclusion Criteria:\n\n* Anticancer therapy, including investigational agents \\\u003C\u002F= 2 weeks or \\\u003C\u002F= 5 half-lives of the drug, whichever is shorter, prior to C1D1. (Use of hydroxyurea is permitted).\n* Inadequate recovery from toxicity attributed to prior anti-cancer therapy to \\\u003C\u002F= Grade 1 (NCI CTCAE v5.0), excluding alopecia or fatigue.\n* Prior treatment with SINE compounds or other inhibitors of XPO1.\n* History of allogeneic hematopoietic stem cell transplant (HCT), or other cellular therapy product, within 3 months.\n* Active acute or chronic GVHD requiring calcineurin inhibitors or steroid dosing \\>\u002F= 10mg\u002Fday or patients within 4 weeks of stopping calcineurin inhibitors for GVHD.\n* Radiation therapy or major surgery within 3 weeks.\n* Active, uncontrolled infection. Patients with infection under active treatment and controlled with antibiotics are eligible. Prophylaxis, even if parenteral, is acceptable.\n* Inability to swallow oral medications.\n* Active documented central nervous system leukemia.\n* Second active malignancy within past 2 years except for basal or squamous cell carcinoma of the skin, ductal carcinoma of breast in situ or cervical carcinoma in situ.\n* Women of childbearing age or potential must have negative pregnancy test and must not be actively breastfeeding to enroll on the study\n* Clinically significant cardiovascular disease with major event or cardiac intervention within the past 6 months (e.g. percutaneous intervention, coronary artery bypass graft, documented cardiac heart failure) as determined by the investigator.\n* Any condition not listed but deemed by the investigator to make the patient a poor candidate for clinical trial and\u002For treatment with investigational agents.",{"count":78,"type":22},60,[54],"This phase I trial tests the safety, side effects, and best dose of eltanexor in combination with venetoclax for the treatment of patients with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Eltanexor works by trapping \"tumor suppressing proteins\" within the cell, thus causing the cancer cells to die or stop growing. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving eltanexor together with venetoclax may be safe, tolerable and\u002For effective in treating patients with relapsed or refractory MDS or AML.",[82,83,28,29,84],"Relapsed Myelodysplastic Syndrome","Refractory Myelodysplastic Syndrome","Refractory Acute Myeloid Leukemia","2026-06-19",{"date":59,"type":34},{"date":88,"type":34},"2024-08-14",{"date":90,"type":22},"2027-10-01",{"name":92,"class":68},"Vanderbilt-Ingram Cancer Center",2,{"id":95,"slug":96,"hasResults":12,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":12,"sex":17,"minAge":50,"maxAge":101,"enrollmentInfo":102,"targetDuration":4,"studyType":23,"phases":104,"briefSummary":106,"conditions":107,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":69},"100295600","phase-1-211at-bc8-b10-before-donor-stem-cell-transplant-in-treating-patients-with-high-risk-acute-myeloid-leukemia-acute-lymphoblastic-leukemia-myelodysplastic-syndrome-or-mixed-phenotype-acute-leukemia-100295600","NCT03128034","211^At-BC8-B10 Before Donor Stem Cell Transplant in Treating Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome, or Mixed-Phenotype Acute Leukemia","A Study Evaluating Escalating Doses of 211^At-Labeled Anti-CD45 MAb BC8-B10 (211^At-BC8-B10) Followed by Allogeneic Hematopoietic Cell Transplantation for High-Risk Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), or Myelodysplastic Syndrome (MDS)","Inclusion Criteria:\n\n* Patients must have AML, ALL, high-risk MDS, or MPAL (also known as biphenotypic) meeting one of the following descriptions:\n\n  * AML, ALL, or MPAL in first remission with evidence of measurable residual disease (MRD) by flow cytometry\n  * AML, ALL, or MPAL beyond first remission (i.e., having relapsed at least one time after achieving remission in response to a treatment regimen)\n  * AML, ALL, or MPAL representing primary refractory disease (i.e., having failed to achieve remission at any time following one or more prior treatment regimens)\n  * AML evolved from myelodysplastic or myeloproliferative syndromes\n  * MDS expressed as refractory anemia with excess blasts (RAEB)\n  * Chronic myelomonocytic leukemia (CMML) by French-American-British (FAB) criteria\n* Patients not in remission must have CD45-expressing leukemic blasts. Patients in remission do not require phenotyping and may have leukemia previously documented to be CD45 negative (because in remission patients, virtually all antibody binding is to non-malignant cells which make up \\>= 95% of nucleated cells in the marrow)\n* Patients must be \\>= 18 and =\\\u003C 75 years of age\n* Patients should have a circulating blast count of less than 10,000\u002Fmm\\^3 (control with hydroxyurea or similar agent is allowed)\n* Patients must have an estimated creatinine clearance greater than 50\u002Fml per minute by the following formula (Cockcroft-Gault); serum creatinine value must be within 28 days prior to registration\n* Patients must have normal hepatic function (bilirubin within normal limits, aspartate aminotransferase \\[AST\\] and alanine aminotransferase \\[ALT\\] \\\u003C 2 times the upper limit of normal) within 2 months prior to the astatine-211 infusion date (with the exception of patients that are known to have Gilbert's disease, for whom total bilirubin is allowed up to 3 x upper limit of normal \\[ULN\\])\n* Eastern Cooperative Oncology Group (ECOG) \\\u003C 2 or Karnofsky \\>= 70\n* Patients must be free of uncontrolled infection\n* Patients with prior non-myeloablative or reduced-intensity conditioning allogeneic-hematopoietic cell transplant (HCT) must have no evidence of ongoing GVHD and be off GVHD treatment immunosuppression for at least 6 weeks at time of enrollment\n* Patients must have normal elastography\n* If ferritin is elevated, patient must have less than 7 mg\u002Fg liver iron concentration on liver T2\\* MRI\n* Patients should have an official gastrointestinal (GI) consult prior to the transplant for full evaluation\n* Patients must have an HLA-matched related donor or an HLA-matched unrelated donor who meets standard Fred Hutch and\u002For National Marrow Donor Program (NMDP) or other donor center criteria for peripheral blood stem cell (PBSC) or bone marrow donation, as follows:\n\n  * Related donor: related to the patient and genotypically or phenotypically identical for HLA-A, B, C, DRB1 and DQB1; phenotypic identity must be confirmed by high-resolution typing\n  * Unrelated donor:\n\n    * Matched for HLA-A, B, C, DRB1 and DQB1 by high resolution typing; OR\n    * Mismatched for a single allele without antigen mismatching at HLA-A, B, or C as defined by high resolution typing but otherwise matched for HLA-A, B, C, DRB1 and DQB1 by high resolution typing\n    * Donors are excluded when preexisting immunoreactivity is identified that would jeopardize donor hematopoietic cell engraftment; the recommended procedure for patients with 10 of 10 HLA allele level (phenotypic) match is to obtain panel reactive antibody (PRA) screens to class I and class II antigens for all patients before HCT; if the PRA shows \\> 10% activity, then flow cytometric or B and T cell cytotoxic cross matches should be obtained; the donor should be excluded if any of the cytotoxic cross match assays are positive; for those patients with an HLA Class I allele mismatch, flow cytometric or B and T cell cytotoxic cross matches should be obtained regardless of the PRA results; a positive anti-donor cytotoxic crossmatch is an absolute donor exclusion\n  * Patient and donor pairs homozygous at a mismatched allele in the graft rejection vector are considered a two-allele mismatch, i.e., the patient is A\\*0101 and the donor is A\\*0102, and this type of mismatch is not allowed\n\nExclusion Criteria:\n\n* Patients may not have symptomatic coronary artery disease and may not be on cardiac medications for anti-arrhythmic or inotropic effects\n* Left ventricular ejection fraction \\\u003C 35%\n* Corrected diffusing capacity of the lungs for carbon monoxide (DLCO) \\\u003C 35% or receiving supplemental continuous oxygen; when pulmonary function test (PFT)s cannot be obtained, the 6-minute walk test (6MWT, also known as exercise oximetry) will be used: Any patient with oxygen saturation on room air of \\\u003C 89% during a 6MWT will be excluded\n* Liver abnormalities: fulminant liver failure, cirrhosis of the liver with evidence of portal hypertension, alcoholic hepatitis, esophageal varices, hepatic encephalopathy, uncorrectable hepatic synthetic dysfunction as evidenced by prolongation of the prothrombin time, ascites related to portal hypertension, bacterial or fungal liver abscess, biliary obstruction, chronic viral hepatitis, or symptomatic biliary disease\n* Patients who are known to be seropositive for human immunodeficiency virus (HIV)\n* Perceived inability to tolerate diagnostic or therapeutic procedures\n* Active central nervous system (CNS) leukemia at time of treatment\n* Patients with prior myeloablative allogeneic-HCT\n* Women of childbearing potential who are pregnant (beta-human chorionic gonadotropin positive \\[beta-HCG+\\] or breast feeding\n* Fertile men and women unwilling to use contraceptives during and for 12 months post-transplant\n* Inability to understand or give an informed consent\n* Allergy to murine-based monoclonal antibodies\n* Known contraindications to radiotherapy","75 Years",{"count":103,"type":22},75,[54,105],"PHASE2","This phase I\u002FII trial studies the side effects and best dose of 211\\^astatine(At)-BC8-B10 before donor stem cell transplant in treating patients with high-risk acute myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndrome, or mixed-phenotype acute leukemia. Radioactive substances, such as astatine-211, linked to monoclonal antibodies, such as BC8, can bind to cancer cells and give off radiation which may help kill cancer cells and have less of an effect on healthy cells before donor stem cell transplant.",[108,109,28,110,111,29,112,113,114,84,115,116],"Acute Lymphoblastic Leukemia","Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome","Chronic Myelomonocytic Leukemia","Myelodysplastic Syndrome With Excess Blasts","Refractory Acute Lymphoblastic Leukemia","Recurrent Acute Lymphoblastic Leukemia","Recurrent Mixed Phenotype Acute Leukemia","Refractory Mixed Phenotype Acute Leukemia","Mixed Phenotype Acute Leukemia","2026-06-18",{"date":119,"type":34},"2026-06-22",{"date":121,"type":34},"2017-10-24",{"date":123,"type":22},"2029-03-31",{"name":67,"class":68},{"id":126,"slug":127,"hasResults":12,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":4,"eligibilityCriteria":131,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":132,"enrollmentInfo":133,"targetDuration":4,"studyType":23,"phases":135,"briefSummary":136,"conditions":137,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":148},"100593869","phase-1-a-study-to-find-the-highest-dose-of-cedazuridine-and-decitabine-combination-with-filgrastim-as-a-treatment-option-after-hematopoietic-stem-cell-transplant-in-children-with-high-risk-acute-myeloid-leukemia-100593869","NCT07012044","A Study to Find the Highest Dose of Cedazuridine and Decitabine Combination With Filgrastim as a Treatment Option After Hematopoietic Stem Cell Transplant in Children With High-Risk Acute Myeloid Leukemia","A Phase 1 Study of Oral Cedazuridine and Decitabine Combination (ASTX727, NSC# 820631) and Filgrastim as Maintenance Therapy Post-Hematopoietic Stem Cell Transplant in Children With High-Risk Acute Myeloid Leukemia","Inclusion Criteria:\n\n* STEP 0: Patient must be ≤ 21 years of age\n\n  * PLEASE NOTE: Eligibility criteria to enroll onto Step 1 for the treatment trial is ≤ 21 years of age at the time of Step 1 enrollment. Please plan accordingly to ensure that patients who are screened with Step 0 will be at an eligible age at the time of enrollment onto Step 1. Patients who are 21 at the time of screening who turn 22 at the time of enrollment onto Step 1 will not be eligible to enroll onto the study\n* STEP 0: Patients with newly diagnosed high risk\\* de novo AML, newly diagnosed therapy-related AML, relapsed, or refractory AML. in complete remission at the time of transplant. Patients with a history of isolated or combined central nervous system (CNS) or extramedullary disease are eligible if they have no evidence of active CNS or extramedullary disease at the time of trial enrollment (Step 0) and treatment enrollment (Step 1). Eligible patients with histories of isolated or combined CNS or extramedullary disease at time of relapse are required to be in complete remission at time of transplant to be eligible for this study\n\n  * Based on risk criteria adopted by the AAML1831 study\n* STEP 0: Patient must plan to have bone marrow sample submitted to Hematologics within 14 days prior to the start of conditioning regimen for HCT.\n\n  * Note: In order to be eligible to enroll onto Step 1 to receive treatment on this study, pre-HCT disease status must be assessed prior to receiving HCT. AML must be in complete remission (Children's Oncology Group \\[COG\\]-complete remission \\[CR\\], COG-complete remission with partial recovery of platelelt count \\[CRp\\], COG-complete remission with incomplete blood count recovery \\[Cri\\], with or without detectable minimal residual disease \\[MRD\\]); bone marrow CR must be assessed by central flow cytometry performed at Hematologics prior to the start of the conditioning regimen\n* STEP 0: Human immunodeficiency virus (HIV)-infected patients are eligible for this trial if the following criteria are met:\n\n  * No history of HIV complications with the exception of CD4 count \\\u003C 200cells\u002Fmm\\^3\n  * No antiretroviral therapy with overlapping toxicity such as myelosuppression\n  * CD4 count \\> 500 cells\u002Fmm\\^3 prior to the diagnosis of newly diagnosed, relapsed, refractory AML.\n  * HIV viral loads below the limit of detection within 6 months, as long as the patient is NOT receiving anti-retroviral agents that may interact with ASTX727.\n  * No history of highly active antiretroviral therapy (HAART)-resistant HIV\n* STEP 0: Patients must be receiving an allogeneic (related, unrelated, and mismatched related, including haploidentical) marrow, peripheral blood, or cord blood transplant for the first time\n* STEP 0: HCT conditioning regimen must be planned to begin within 14 days after bone marrow assessment to determine disease status\n* STEP 0: Conditioning regimen must be myeloablative and include high dose busulfan, or treosulfan, or total body irradiation\n* STEP 0: Patients must not have received prior exposure to ASTX727. Note that patients may have had prior exposure to decitabine\n* STEP 1: Patient must be ≤ 21 years of age at the time of study enrollment to step 0 and step 1\n* STEP 1: Patients must have a body surface area ≥ 1m\\^2 at enrollment to step 1\n* STEP 1 (PRE-HCT): AML must be in complete remission (COG-CR, COG-CRp, COG-Cri), with or without detectable MRD; bone marrow CR must be assessed by central flow cytometry performed at Hematologics. Disease assessment must be performed within 14 days prior to the start of HCT conditioning regimen\n\n  * Patients with CNS or extramedullary disease within 14 days prior to the start of the HCT condition regimen are not eligible\n* STEP 1 (POST-HCT): AML must be in complete remission (COG-CR, COG-CRp, COG-CRi). Bone marrow evaluation must show CR with no detectable minimal residual disease (MRD negative by central flow cytometry at Hematologics)\n\n  * Note: Disease assessment is required to be performed within 14 days prior to enrollment onto Step 1\n  * Patients with CNS or extramedullary disease post-HCT are not eligible\n* STEP 1: Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients \\> 16 years of age and Lansky for patients ≤ 16 years of age. Patients must have Karnofsky performance score ≥ 50 or Lansky play-performance scale score ≥ 50\n* STEP 1: Patients must have fully recovered from the acute toxicities related to the conditioning regimen and the transplant. If, after 42-100 days post-transplant, the eligibility criteria are met, the patient is considered to have recovered adequately\n* STEP 1: Platelet count ≥ 50,000 µL (without requirement for platelet transfusion within the last 7 days)\n* STEP 1: Hemoglobin ≥ 8.0 g\u002FdL at baseline (may receive red blood cell \\[RBC\\] transfusions)\n* STEP 1: Absolute neutrophil count ≥ 1,000 µL with no myeloid growth factor support within the last 3 days\n* Estimated glomerular filtration rate (GFR) (eGFR) ≥ 60 mL\u002Fmin\u002F1.73 m\\^2 \"Bedside\" Schwartz formula (2009) OR\n\n  * OR- A 24 hour urine creatinine clearance ≥ 60 mL\u002Fmin\u002F1.73 m\\^2\n  * A GFR ≥ 60 mL\u002Fmin\u002F1.73 m\\^2. GFR must be performed using direct measurement with a nuclear blood sampling method OR direct small molecule clearance method (iothalamate or other molecule per institutional standard)\n  * Note: Estimated GFR (eGFR) from cystatin C or other estimates not listed above are not acceptable for determining eligibility\n* STEP 1: Bilirubin (total or sum of conjugated + unconjugated) ≤ 1.5 x upper limit of normal (ULN) for age\n* STEP 1: Alanine aminotransferase (ALT) ≤ 3 x ULN\n* STEP 1: Aspartate aminotransferase (AST) ≤ 3 x ULN\n* STEP 1: Albumin ≥ 2 g\u002FdL\n\nExclusion Criteria:\n\n* STEP 0: Patients with known inherited marrow failure syndromes, including, but not limited to Fanconi Anemia, Dyskeratosis congenita, and Shwachman-Diamond syndrome\n* STEP 0: Known or suspected hypersensitivity to filgrastim, decitabine or cedazuridine (ASTX727)\n* STEP 0: Patients who have received a prior solid organ transplantation are not eligible\n* STEP 1: ASTX727 can cause fetal harm when administered to pregnant women. Pregnancy tests must be obtained in girls who are post-menarchal. Males or females of reproductive potential may not participate unless they have agreed to use two effective methods of birth control, including a medically accepted barrier or contraceptive method (eg, male or female condom) for the duration of the study. Abstinence is an acceptable method of birth control. Women of childbearing potential must use highly effective contraception during treatment with ASTX727 and for at least 6 months after the last dose. Men with female partners of childbearing potential should be advised to practice highly effective contraceptive measures of birth control and not to father a child while receiving treatment with decitabine and for 3 months after the last dose. Breastfeeding is not allowed during the study and for at least 2 weeks after the last dose of study drug\n* STEP 1: Patients who are currently receiving another investigational drug are not eligible\n* STEP 1: Patients who are currently receiving other anti-cancer agents are not eligible. Patients receiving intrathecal chemotherapy in the prior 14 days are eligible\n* STEP 1: Patients receiving or for whom there is a plan to administer anticancer non-protocol therapy, radiation therapy or immunotherapy during the study period are not eligible (note that prophylactic use of chemotherapeutic agents for graft versus host disease \\[GVHD\\] is allowed, e.g. methotrexate for GVHD prophylaxis). Intrathecal cytarabine administered at the discretion of the treating physician throughout maintenance therapy is allowed\n* STEP 1: Drugs known to be metabolized by cytidine deaminase (CDA) should not be given (such drugs include cytarabine, gemcitabine, azacitidine, vidarabine, zalcitabine, zidovudine, telbivudine, didanosine, stavudine, lamivudine, abacavir, emtricitabine, entecavir, trifluridine, tenofovir and adefovir) on days when ASTX727 is administered and for 24 hours thereafter\n* STEP 1: Patients is not able to swallow intact tablets. Nasogastric or G tube administration is not allowed\n* STEP 1: Patient is not able to start ASTX727 and filgrastim (rh-GCSF) between day 42 and day 100 following completion of allo-HCT. If, after enrollment, protocol therapy is started more than 100 days following allo-HCT, the patient will be removed from protocol therapy\n* STEP 1: Patients with graft loss are not eligible\n* STEP 1: Patients with steroid refractory or dependent acute GVHD are not eligible. Patients must be on \\\u003C 1 mg\u002Fkg\u002Fday of methylprednisolone (or equivalent prednisone\u002Fprednisolone dose) that is being tapered. Patients must not be on any second line systemic therapies. Continued GVHD prophylaxis with calcineurin inhibitors, sirolimus, abatacept or mycophenolate mofetil is acceptable\n* STEP 1: Patients who have an uncontrolled viral, bacterial, fungal, or protozoal infection are not eligible\n* STEP 1: Patients with active transplant associated thrombotic microangiopathy with ongoing hemolysis and need treatment (e.g. eculizumab) are not eligible\n* STEP 1: Patients with sinusoidal obstruction syndrome with ongoing need for treatment (e.g. defibrotide, diuresis, supplemental oxygen) are not eligible\n* STEP 1: Idiopathic pneumonitis syndrome or other non-infectious lung injury requiring ongoing treatment (corticosteroids, tumor necrosis factor \\[TNF\\] inhibitors, or other biologics) or supplemental oxygen are not eligible\n* STEP 1: Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible","21 Years",{"count":134,"type":22},47,[54],"This phase I trial tests the safety, side effects, and best dose of ASTX727 and filgrastim for the treatment of children with high risk acute myeloid leukemia that has come back after a period of improvement (recurrent) or that does not respond to treatment (refractory) who have undergone allogenic hematopoietic stem cell transplantation. ASTX727 is a combination of cedazuridine and decitabine. Cedazuridine is in a class of medications called cytidine deaminase inhibitors. It prevents the breakdown of decitabine, making it more available in the body so that decitabine will have a greater effect. Decitabine is in a class of medications called hypomethylation agents. It works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow. Filgrastim stimulates the production of neutrophils (a type of white blood cell) which can help to prevent infection. Giving ATSX727 and filgrastim may be safe and tolerable in treating children with high risk, recurrent or refractory acute myeloid leukemia who have undergone allogenic hematopoietic stem cell transplantation.",[138,29,84],"Acute Myeloid Leukemia Post Cytotoxic Therapy","2026-06-17",{"date":117,"type":34},{"date":142,"type":34},"2026-06-09",{"date":144,"type":22},"2027-03-31",{"name":146,"class":147},"National Cancer Institute (NCI)","NIH",7,{"id":150,"slug":151,"hasResults":12,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":4,"eligibilityCriteria":155,"healthyVolunteers":12,"sex":17,"minAge":50,"maxAge":101,"enrollmentInfo":156,"targetDuration":4,"studyType":23,"phases":158,"briefSummary":159,"conditions":160,"keywords":164,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":168,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":69},"100337247","phase-1-211at-bc8-b10-followed-by-donor-stem-cell-transplant-in-treating-patients-with-relapsed-or-refractory-high-risk-acute-leukemia-or-myelodysplastic-syndrome-100337247","NCT03670966","211At-BC8-B10 Followed by Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory High-Risk Acute Leukemia or Myelodysplastic Syndrome","A Phase I\u002FII Study Evaluating Escalating Doses of 211At-Labeled Anti-CD45 MAb BC8-B10 (211At-BC8-B10) Followed by Related Haplo-Identical Allogeneic Hematopoietic Cell Transplantation for High-Risk Acute Leukemia or Myelodysplastic Syndrome (MDS)","Inclusion Criteria:\n\n* Patients must have AML, ALL, high-risk MDS, or MPAL (also known as biphenotypic) meeting one of the following descriptions:\n\n  * AML, ALL, or MPAL in first remission with evidence of measurable residual disease (MRD) by flow cytometry;\n  * AML, ALL, or MPAL beyond first remission (i.e., having relapsed at least one time after achieving remission in response to a treatment regimen);\n  * AML, ALL, or MPAL representing primary refractory disease (i.e., having failed to achieve remission at any time following one or more prior treatment regimens);\n  * AML evolved from myelodysplastic or myeloproliferative syndromes;\n  * MDS expressed as refractory anemia with excess blasts (RAEB)\n  * Chronic myelomonocytic leukemia (CMML) by French-American-British (FAB) criteria.\n* Patients not in remission must have CD45-expressing leukemic blasts. Patients in remission do not require phenotyping and may have leukemia previously documented to be CD45 negative (because in remission patients, virtually all antibody binding is to non-malignant cells which make up \\>= 95% of nucleated cells in the marrow).\n* Patients must be \\>= 18 and =\\\u003C 75 years of age.\n* Patients should have a circulating blast count of less than 10,000\u002Fmm\\^3 (control with hydroxyurea or similar agent is allowed).\n* Patients must have an estimated creatinine clearance greater than 50\u002Fml per minute by the following formula (Cockcroft-Gault). Serum creatinine value must be within 28 days prior to registration.\n* Total bilirubin within normal limits\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C 2 times the upper limit of normal.\n* Eastern Cooperative Oncology Group (ECOG) \\\u003C 2 or Karnofsky \\>= 70.\n* Patients must be free of uncontrolled infection.\n* Patients with prior non-myeloablative or reduced-intensity conditioning allogeneic-HCT must have no evidence of ongoing GVHD and be off all immunosuppression for at least 6 weeks at time of enrollment.\n* Patients must have normal elastography.\n* If ferritin is elevated, patient must have less than 7 mg\u002Fg liver iron concentration on liver T2 magnetic resonance imaging (MRI).\n* Patients should have an official gastrointestinal (GI) consult prior to the transplant for full evaluation.\n* Patients must have a related donor who is identical for one HLA haplotype and mismatched at the HLA-A, -B or DRB1 loci of the unshared haplotype with the exception of single HLA-A, -B or DRB1 mismatches.\n* DONOR: Donors must meet HLA matching criteria as well as standard Seattle Cancer Care Alliance (SCCA) criteria for PBSC or bone marrow donation. Preference should be given to donors who are mismatched at the HLA-A, -B and -DRB1 loci.\n\nExclusion Criteria:\n\n* Patients may not have symptomatic coronary artery disease and may not be on cardiac medications for anti-arrhythmic or inotropic effects.\n* Left ventricular ejection fraction \\\u003C 45%.\n* Corrected diffusion capacity of the lung for carbon monoxide (DLCO) \\\u003C 35% or receiving supplemental continuous oxygen. When pulmonary function tests (PFTs) cannot be obtained, the 6-minute walk test (6MWT, also known as exercise oximetry) will be used: Any patient with oxygen saturation on room air of \\\u003C 89% during a 6MWT will be excluded\n* Liver abnormalities: fulminant liver failure, cirrhosis of the liver with evidence of portal hypertension, alcoholic hepatitis, esophageal varices, hepatic encephalopathy, uncorrectable hepatic synthetic dysfunction as evidenced by prolongation of the prothrombin time, ascites related to portal hypertension, bacterial or fungal liver abscess, biliary obstruction, chronic viral hepatitis, or symptomatic biliary disease.\n* Patients who are known to be seropositive for human immunodeficiency virus (HIV).\n* Perceived inability to tolerate diagnostic or therapeutic procedures.\n* Active central nervous system (CNS) leukemia at time of treatment.\n* Patients with prior myeloablative allogeneic-HCT.\n* Women of childbearing potential who are pregnant (beta human chorionic gonadotropin \\[B-HCG\\]+) or breast feeding.\n* Fertile men and women unwilling to use contraceptives during and for 12 months post-transplant.\n* Inability to understand or give an informed consent.\n* Allergy to murine-based monoclonal antibodies.\n* Known contraindications to radiotherapy.",{"count":157,"type":22},30,[54,105],"This phase I\u002FII trial studies the side effects and best dose of a radioactive agent linked to an antibody (211At-BC8-B10) followed by donor stem cell transplant in treating patients with high-risk acute leukemia or myelodysplastic syndrome that has come back (recurrent) or isn't responding to treatment (refractory). 211At-BC8-B10 is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Giving chemotherapy and total body irradiation before a stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. When the healthy stem cells from a donor are infused into the patient, they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can attack the body's normal cells, called graft versus host disease. Giving cyclophosphamide, mycophenolate mofetil, and tacrolimus after a transplant may stop this from happening.",[161,109,162,110,111,113,29,112,84,114,115,163],"Acute Lymphoblastic Leukemia in Remission","Acute Myeloid Leukemia in Remission","Hematopoietic and Lymphoid Cell Neoplasm",[165,166,167],"Lymphoid Leukemia","Myeloid and Monocytic Leukemia","Other Hematopoietic",{"date":119,"type":34},{"date":170,"type":34},"2019-07-10",{"date":172,"type":22},"2029-10-20",{"name":67,"class":68},{"id":175,"slug":176,"hasResults":12,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":4,"eligibilityCriteria":180,"healthyVolunteers":12,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":181,"targetDuration":4,"studyType":23,"phases":183,"briefSummary":184,"conditions":185,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":69},"100594908","phase-1-miristen-for-the-treatment-of-relapsed-or-refractory-acute-myeloid-leukemia-100594908","NCT07025564","MiRisten for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia","A Phase 1 Trial of miRisten in Adult Patients With Relapsed\u002FRefractory AML","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative.\n* Agreement to allow the use of archival tissue from diagnostic tumor biopsies\n\n  * If unavailable, exceptions may be granted with study principal investigator (PI) approval.\n* ≥ 18 years.\n* Eastern Cooperative Oncology Group (ECOG) ≤ 2.\n* Patients with histologically confirmed AML, according to International Consensus Classification (ICC) or World Health Organization (WHO) criteria, with relapsed or refractory (R\u002FR) disease who have failed treatment with, or are ineligible for, available therapies known to be active for treatment of AML.\n\n  * Patients with extramedullary disease may be included if they also have concurrent marrow disease.\n* Fully recovered from the acute toxic effects (except alopecia) to ≤ grade 1 to prior anti-cancer therapy.\n* Life expectancy of ≥ 3 months.\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (performed within 28 days prior to day 1 of protocol therapy unless otherwise stated).\n* Aspartate aminotransferase (AST) ≤ 3 x ULN (performed within 28 days prior to day 1 of protocol therapy unless otherwise stated).\n* Alanine aminotransferase (ALT) ≤ 3 x ULN (performed within 28 days prior to day 1 of protocol therapy unless otherwise stated).\n* Creatinine clearance of ≥ 60 mL\u002Fmin per 24-hour urine test or the Cockcroft-Gault formula (performed within 28 days prior to day 1 of protocol therapy unless otherwise stated).\n* International normalized ratio (INR) or prothrombin (PT) ≤ 1.5 x ULN (performed within 28 days prior to day 1 of protocol therapy unless otherwise stated).\n* Activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN (performed within 28 days prior to day 1 of protocol therapy unless otherwise stated).\n* Left ventricular ejection fraction (LVEF) ≥ 45% (performed within 28 days prior to day 1 of protocol therapy unless otherwise stated).\n* Corrected QT interval (QTcF) ≤ 480 ms based on Fridericia's formula\n\n  * Note: To be performed within 28 days prior to day 1 of protocol therapy.\n* Women of childbearing potential (WOCBP): negative urine or serum pregnancy test (performed within 28 days prior to day 1 of protocol therapy unless otherwise stated).\n\n  * If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n* Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 3 months after the last dose of protocol therapy.\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only).\n\nExclusion Criteria:\n\n* Allogeneic hematopoietic stem cell transplant within 3 months prior to day 1 of protocol therapy. Patients must be off calcineurin inhibitors for at least 2 weeks prior to day 1 of protocol therapy.\n* Chemotherapy, radiation therapy, biological therapy, immunotherapy within 14 days prior to day 1 of protocol therapy, with the exception of hydroxyurea.\n* Strong and moderate CYP3A4 inducers and strong CYP3A inhibitors (with the exception of azole antifungals) within 7 days prior to day 1 of protocol therapy.\n* Foods\u002Fsupplements that are strong inhibitors or strong or moderate inducers of CYP3A (such as St. John's wort) within 3 days prior to initiation of and during study treatment.\n* Systemic steroid therapy \\> 10 mg\u002Fday (≤ 10mg\u002Fday prednisone equivalent ok) or any other form of immunosuppressive medication within 14 days. Inhaled or topical steroids, and adrenal replacement steroid doses ≤10 mg daily prednisone equivalent, are permitted. Steroids given for study drug infusion reaction prophylaxis or infusion reactions should not count towards this maximum.\n* Must not have received or planning to receive live vaccine while being on study or 28 days before and after completion of treatment.\n* Acute promyelocytic leukemia (APL).\n* History of allergic or infusion reactions attributed to compounds of similar chemical or biologic composition to study agent.\n* Inability to tolerate dexamethasone at the doses prescribed in this protocol.\n* Unstable cardiac disease as defined by the following:\n\n  * Unstable angina\n  * Uncontrolled atrial fibrillation or hypertension\n  * Acute coronary syndrome and\u002For revascularization (e.g., coronary artery bypass graft, stent) within 6 months of first dose of study drug.\n* Clinically significant uncontrolled illness.\n* Uncontrolled active infection.\n* Other active malignancy. Patients with a prior or concurrent malignancy whose natural history or treatment have the potential to interfere with the safety or efficacy assessment of the investigational regimen are not eligible for this trial. Low grade indolent malignancies may be allowed if not actively undergoing treatment (such as non-melanoma skin cancers, low grade prostate cancer and others per the PI discretion).\n* Females only: Pregnant or breastfeeding.\n* Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures.\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues).",{"count":182,"type":22},12,[54],"This phase I trial tests the safety, side effects, and best dose of miRisten in treating patients with acute myeloid leukemia (AML) that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). MiRisten may stop the growth of cancer cells by blocking some of the molecules needed for cell growth. Giving miRisten may be safe, tolerable and\u002For effective in treating patients with relapsed or refractory AML.",[29,84],"2026-06-15",{"date":139,"type":34},{"date":189,"type":34},"2025-10-24",{"date":191,"type":22},"2028-08-01",{"name":193,"class":68},"City of Hope Medical Center",{"id":195,"slug":196,"hasResults":12,"nctId":197,"briefTitle":198,"officialTitle":199,"acronym":4,"eligibilityCriteria":200,"healthyVolunteers":12,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":201,"targetDuration":4,"studyType":23,"phases":202,"briefSummary":203,"conditions":204,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":205,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":69},"100459489","phase-1-8-chloroadenosine-in-combination-with-venetoclax-for-the-treatment-of-patients-with-relapsedrefractory-acute-myeloid-leukemia-100459489","NCT05263284","8-Chloroadenosine in Combination With Venetoclax for the Treatment of Patients With Relapsed\u002FRefractory Acute Myeloid Leukemia","A Phase 1 Trial of 8-Chloro-Adenosine in Combination With Venetoclax in Patients With Relapsed\u002FRefractory Acute Myeloid Leukemia","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative.\n* Age: \\>= 18 years.\n* Eastern Cooperative Oncology Group (ECOG) =\\\u003C 2.\n* Life expectancy \\> 3 months.\n* Patients with histologically confirmed acute myeloid leukemia (AML), according to World Health Organization (WHO) criteria, with relapsed\u002Frefractory disease.\n* Patients must have any one of the following treatment history criteria:\n\n  * Relapsed AML\n\n    * Failed at least 1 line of salvage therapy or\n    * Untreated relapse and are not candidates for allogeneic hematopoietic stem cell transplantation (alloHCT)\n  * De novo AML\n\n    * have not achieved complete response (CR) after 2 lines of therapy or\n    * refractory to frontline therapy and not eligible for alloHCT\n  * AML evolving from myelodysplastic syndrome (MDS) or myeloproliferative disorder who have failed hypomethylating agents (HMA) or induction chemotherapy\n  * Patients who have relapsed after allo-HCT are eligible if they are at least 3 months after HCT, do not have active graft versus host disease (GVHD) and are off immunosuppression except for maintenance dose of steroids (prednisone 10 mg\u002Fday or less).\n* Male subjects must agree to not donate sperm while taking protocol therapy through at least 90 days after the last dose.\n* White blood cell (WBC) =\\\u003C 25 x 10\\^9\u002FL prior to initiation of venetoclax. Cytoreduction with hydroxyurea prior to treatment and\u002For during cycle 1 may be required.\n* Total bilirubin =\\\u003C 1.5 X upper limit of normal (ULN) (unless has Gilbert's disease).\n* Aspartate aminotransferase (AST) =\\\u003C 2.5 x ULN.\n* Alanine aminotransferase (ALT) =\\\u003C 2.5 x ULN.\n* Creatinine clearance of \\>= 50 mL\u002Fmin per 24 hour urine test or the Cockcroft-Gault formula.\n* QTc =\\\u003C 480 ms.\n* Women of childbearing potential (WOCBP): negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n* Agreement by females and males of childbearing potential\\* to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 6 months (females) and 3 months (males) after the last dose of protocol therapy.\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only).\n\nExclusion Criteria:\n\n* Current or planned use of other investigational agents, antineoplastic, biological, chemotherapy, or radiation therapy during the study treatment period, or within 2 weeks prior to day 1 of protocol therapy, with the following exception:\n\n  * Hydroxyurea which may be continued through cycle 1.\n* Expected to undergo HCT within 120 days of enrollment.\n* Current or planned use of agents that prolong or suspected to prolong QTc.\n* Received strong or moderate CYP3A inducers or St. John's Wort within 7 days prior to day 1 of protocol therapy.\n* Received strong or moderate CYP3A inhibitors, or consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges) or Star fruit within 3 days prior to day 1 of protocol therapy.\n* P-glycoprotein (P-gp) inhibitors within 7 days prior to day 1 of protocol therapy.\n* Narrow therapeutic index P-gp substrates within 7 days prior to day 1 of protocol therapy.\n* Acute promyelocytic leukemia.\n* Active central nervous system (CNS) leukemia.\n* Active fungal infection or bacterial sepsis.\n* Class III\u002FIV cardiovascular disability according to the New York Heart Association classification.\n* Participants with clinically significant arrhythmia or arrhythmias not stable on medical management within two weeks of enrollment. Subjects with controlled, asymptomatic atrial fibrillation can enroll.\n* History of acute cardiovascular ischemic event, i.e., myocardial infarction or unstable angina within 6 months of enrollment.\n* History of unexplained syncope, significant histories of CAD (requiring revascularization by percutaneous coronary intervention \\[PCI\\] or coronary artery bypass grafting \\[CABG\\]), cardiomyopathy (ejection fraction \\[EF\\] \\\u003C 50%).\n* Prior surgery or gastrointestinal dysfunction that may affect drug absorption (e.g., gastric bypass surgery, gastrectomy).\n* Unable to swallow capsules, has a partial or small bowel obstruction, or has a gastrointestinal condition resulting in a malabsorptive syndrome (e.g. small bowel resection with malabsorption).\n* Active peptic ulcer disease.\n* Other active malignancy except for localized skin cancer, bladder, prostate, breast or cervical carcinoma in situ.\n* Females only: Pregnant or breastfeeding.\n* Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures.\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics).",{"count":157,"type":22},[54],"This phase I trial tests the safety, side effects, and best dose of a new 8-chloroadenosine in combination with venetoclax in treating patients with acute myeloid leukemia that has come back (relapsed) or does not respond to treatment (refractory). 8-Chloroadenosine may help block the formation of growths that may become cancer. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving 8-chloroadenosine in combination with venetoclax may help prevent the disease from coming back in patients with acute myeloid leukemia.",[28,29,84],{"date":139,"type":34},{"date":207,"type":34},"2022-12-15",{"date":209,"type":22},"2029-01-25",{"name":193,"class":68},{"id":212,"slug":213,"hasResults":12,"nctId":214,"briefTitle":215,"officialTitle":216,"acronym":4,"eligibilityCriteria":217,"healthyVolunteers":12,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":218,"targetDuration":4,"studyType":23,"phases":220,"briefSummary":221,"conditions":222,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":227,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":234},"100553282","phase-1-testing-the-anti-cancer-drug-cirtuvivint-and-its-combination-with-astx727-to-improve-outcomes-in-patients-with-acute-myeloid-leukemia-and-myelodysplastic-syndromes-100553282","NCT06484062","Testing the Anti-cancer Drug, Cirtuvivint, and Its Combination With ASTX727 to Improve Outcomes in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndromes","A Phase I Study Evaluating the Safety of Cirtuvivint as Monotherapy and in Combination With ASTX727 in Patients With Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML)","Inclusion Criteria:\n\n* In Cohorts I and II, patients must have R\u002FR AML or MDS (venetoclax naïve or venetoclax exposed)\n\n  * Relapsed AML is defined as the appearance of 5% or greater myeloblasts in the bone marrow or peripheral blood after achieving a complete remission (CR), CR with partial hematologic recovery (CRh), or CR with incomplete hematologic recovery (CRi). Patients with a mutation in FLT3, IDH1 or IDH2 must have failed or been intolerant of a corresponding Food and Drug Administration (FDA) approved FLT3, IDH1 or IDH2 inhibitor before enrolling on study. The initial diagnosis of AML is defined by the ELN 2022 criteria, and therefore patients with either AML (peripheral blood or bone marrow blasts ≥ 20% or blasts ≥ 10% with recurrent genetic abnormalities) or MDS\u002FAML (peripheral blood or bone marrow blasts 10-19%) are eligible\n  * Refractory AML is defined as failure to achieve a CR, CRh, or CRi after one of the following regimens: (i) ≥ 2 cycles of intensive induction chemotherapy with a cytarabine containing regimen (e.g., 7+3, mitoxantrone, etoposide, cytarabine \\[MEC\\], high-dose cytarabine \\[HIDAC\\], reinduction chemotherapy such as 5 + 2, etc.) or, (ii) ≥ 2 cycles of hypomethylating agent (HMA)\u002Fvenetoclax or low-dose cytarabine (LDAC)\u002Fglasdegib or, (iii) ≥ 4 cycles of HMA monotherapy. The initial diagnosis of AML is defined by the ELN 2022 criteria, and therefore patients with either AML (peripheral blood or bone marrow blasts ≥ 20% or blasts ≥ 10% with recurrent genetic abnormalities) or MDS\u002FAML (peripheral blood or bone marrow blasts 10-19%) are eligible\n  * Patients with MDS\u002FAML (blasts 10-19%) who progress to AML (blasts ≥ 20%) after treatment will be considered relapsed or refractory MDS\u002FAML, and not as newly-diagnosed AML (i.e. the patients' treatment history for eligibility purposes does not reset)\n  * Relapsed MDS is defined as: (i) Intermediate, high, or very high-risk disease by International Prognostic Scoring System-Revised (IPSS-R) and, (ii) Any relapse after achieving any 2023 IWG MDS defined response\n  * Refractory MDS is defined as: (i) Intermediate, high, or very high-risk disease by IPSS-R and \\> 5% blasts in the bone marrow or peripheral blood, (ii) Failure to achieve a response (as per IWG 2006 criteria) after ≥ 4 cycles of HMA monotherapy, or (iii) ≥ 2 cycles of HMA + venetoclax\n* In Cohort III, patients must have prior untreated high-risk MDS\n\n  * MDS with \\> 5% blasts in the bone marrow or peripheral blood AND\n  * IPSS-R high or very high-risk disease OR\n  * Molecular International Prognostic Scoring System (IPSS-M) high or very high-risk disease\n  * No more than one single prior cycle of DNMTi therapy\n  * Prior use of erythropoiesis stimulating agents (ESA), thrombopoietin agonists, lenalidomide, and luspatercept are allowed\n* Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of SM08502 (cirtuvivint) in combination with ASTX727 in patients \\\u003C 18 years of age, children are excluded from this study\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3\n* Total bilirubin ≤ 2 x institutional upper limit of normal (ULN) (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin; in that case a cut off of ≤ 4 × institutional ULN will be used)\n* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT)(serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 3 x institutional ULN (unless considered due to organ involvement by the patient's myeloid malignancy; in that case a cut off of ≤ 5 x institutional ULN will be used)\n* Glomerular filtration rate (GFR) ≥ 45 mL\u002Fmin\u002F1.73m\\^2\n* If female, patient must be either:\n\n  * Postmenopausal (surgically sterile or age \\> 55 years with no menses for 12 or more months without an alternative medical cause or age equal to 55 or less with no menses for 12 or more months without an alternative medical cause and a follicle stimulating hormone \\[FSH\\] level \\> 40 IU\u002FL); or\n  * Of children bearing potential. These patients must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Patient must agree to have a negative urine or serum beta-human chorionic gonadotropin (HCG) test result during screening and repeated within 7 days prior to study drug (local labs are allowed) to be eligible\n* The effects of SM08502 (cirtuvivint) and ASTX727 on the developing human fetus are unknown. For this reason, and because these agents are known to be teratogenic, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and during the treatment therapy. Women of childbearing age should agree to use adequate contraception for 7 months after completion of SM08502 (cirtuvivint) administration. For ASTX727, adequate contraception must continue for at least 6 months after last dose of ASTX727. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study and for the duration of the study and at least 4 months after the last dose of SM08502 (cirtuvivint) and 3 months after last dose of ASTX727. Women who are lactating must refrain from breastfeed during the study and at least for two weeks after last dose of ASTX727\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants\n\nExclusion Criteria:\n\n* Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> grade 1) with the exception of alopecia or abnormal blood counts\n* Patients who are receiving any other investigational agents\n* Systemic anti-leukemic or other antineoplastic therapy within 14 days of first day of study treatment. Hydroxyurea may be continued through cycle 1 of treatment. Hydroxyurea is discouraged in subsequent cycles and should be discussed beforehand with principal investigator. If on venetoclax, then a wash-out period of at least five times the half-life of venetoclax is required. Exceptions: No wash-out required for intrathecal chemotherapy, hydroxyurea, cytarabine (Ara-C), or palliative radiation therapy to painful sites of leukemic disease. Patients are not allowed to receive concurrent therapy such as cytotoxic chemotherapy or radiation therapy for another cancer. Patients on hormonal adjuvant therapy for non-metastatic breast and prostate cancer or other minimally-myelosuppressive maintenance therapies for non-metastatic cancer may be eligible at the discretion of the study principal investigator (PI)\n* Patient is receiving known inhibitors or activators of flavin-containing monooxygenases (FMO1 or FMO3), and these cannot be stopped at least 5 days prior to SM08502 (cirtuvivint) treatment start. Known inhibitors of FOMO are chlorpromazine and imipramine\n* Patient is receiving strong inhibitors or strong inducers of CYP3A4\u002F5 and these cannot be stopped at least 5 days prior to SM08502 (cirtuvivint) treatment start\n\n  * Strong inhibitors include grapefruit juice or grapefruit\u002Fgrapefruit related citrus fruits (e.g., Seville oranges, pomelos), ketoconazole, miconazole, itraconazole, voriconazole, posaconazole, clarithromycin, telithromycin, indinavir, saquinavir, ritonavir, nelfinavir, amprenavir, fosamprenavir, nefazodone, lopinavir, troleandomycin, mibefradil, and conivaptan. Examples may be found at the FDA website. Refer to the prescribing information of concomitant medications if in doubt or consult the sponsor for guidance\n  * Strong inducers include phenobarbital, rifampin, phenytoin, carbamazepine, rifabutin, rifapentin, clevidipine, and St. John's Wort. Examples may be found at the FDA website. Refer to the prescribing information of concomitant medications if in doubt or consult the sponsor for guidance.\n  * While moderate inhibitors or moderate inducers of CYP3A4\u002F5 are not an exclusion criteria for the trial, it is preferred that moderate inhibitors or moderate inducers of CYP3A4\u002F5 be replaced prior to the first dose of SM08502 (cirtuvivint) and during study conduct where this is possible.\n\n    * Moderate inhibitors include erythromycin, ciprofloxacin, verapamil, diltiazem, atazanavir, fluconazole, darunavir, delavirdine, amprenavir, fosamprenavir, aprepitant, imatinib, tofisopam, and cimetidine. Examples may be found at the FDA website. Refer to the prescribing information of concomitant medications if in doubt or consult the sponsor for guidance\n    * Moderate inducers include bosentan, efavirenz, etravirine, modafinil, and nafcillin. Examples may be found at the FDA website. Refer to the prescribing information of concomitant medications if in doubt or consult the sponsor for guidance\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to SM08502 (cirtuvivint) or ASTX727\n* Chronic, active hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment. Note: patients with serologic evidence of prior vaccination to HBV (i.e. hepatitis B surface \\[HBs\\] antigen negative, anti-HBs antibody positive and anti-hepatitis B core \\[HBc\\] antibody negative) or positive anti-HBc antibody from intravenous immunoglobulins (IVIG) may participate. Patients who had prior HCV that has been definitively treated with negative HCV viral load prior to study initiation and no evidence of cirrhosis, are allowed to participate. If there is no known history of HBV infection no HBV studies need to be obtained. If there is no known history of HCV infection, no HCV studies need to be obtained\n* Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous\n* Pregnant and lactating women are excluded from this study because SM08502 (cirtuvivint) is a small molecule inhibitor of CLK DYRK with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with SM08502 (cirtuvivint), breastfeeding should be discontinued if the mother is treated with SM08502 (cirtuvivint). These potential risks may also apply to other agents used in this study\n* Patients with acute promyelocytic leukemia\n* Subject has symptomatic central nervous system (CNS) involvement with AML\n* Patient has immediate life-threatening, severe complications of their myeloid malignancy such as uncontrolled bleeding and\u002For uncontrolled infection\n* Patient has significant active cardiac disease within 6 months prior to the start of study treatment, including uncontrolled New York Heart Association (NYHA) class III or IV congestive heart failure; acute coronary syndrome (ACS); and\u002For stroke\n* Left ventricular ejection fraction (LVEF) \\\u003C 40% by echocardiogram (ECHO) or multi-gated acquisition (MUGA) scan obtained within 30 days prior to the start of study treatment\n* Patient is known to have dysphagia, short-gut syndrome, gastroparesis, or other conditions that limit the ingestion or gastrointestinal absorption of drugs administered orally. Patient needs to be able to swallow pills\n* Patient has active uncontrolled systemic fungal, bacterial, or viral infection (defined as ongoing signs\u002Fsymptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and\u002For other treatment)\n* Subject has prolonged corrected QC (QTc) interval (Fridericia's correction \\[QTcF\\]) ≥ 480 ms or known family history of long QT interval syndrome at screening",{"count":219,"type":22},54,[54],"This phase I trial tests the safety, side effects, and best dose of SM08502 (cirtuvivint) alone and in combination with ASTX727 in treating patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). Cirtuvivint may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. ASTX727 is a combination of two drugs, decitabine and cedazuridine. Decitabine is in a class of medications called hypomethylation agents. It works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow. Cedazuridine is in a class of medications called cytidine deaminase inhibitors. It prevents the breakdown of decitabine, making it more available in the body so that decitabine will have a greater effect. Giving cirtuvivint alone or in combination with ASTX727 may be safe, tolerable, and\u002For effective in treating patients with AML and MDS.",[28,57,223,29,58,224,84,83,225],"Myelodysplastic Syndrome\u002FAcute Myeloid Leukemia","Recurrent Myelodysplastic Syndrome\u002FAcute Myeloid Leukemia","Refractory Myelodysplastic Syndrome\u002FAcute Myeloid Leukemia","2026-06-10",{"date":228,"type":34},"2026-06-11",{"date":230,"type":34},"2025-08-15",{"date":232,"type":22},"2028-06-01",{"name":146,"class":147},22,{"id":236,"slug":237,"hasResults":12,"nctId":238,"briefTitle":239,"officialTitle":240,"acronym":4,"eligibilityCriteria":241,"healthyVolunteers":12,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":242,"targetDuration":4,"studyType":23,"phases":243,"briefSummary":244,"conditions":245,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":248,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":253,"locationsCount":69},"100400356","phase-2-cpx-351-and-ivosidenib-for-the-treatment-of-idh1-mutated-acute-myeloid-leukemia-or-high-risk-myelodysplastic-syndrome-100400356","NCT04493164","CPX-351 and Ivosidenib for the Treatment of IDH1 Mutated Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome","Phase II Investigator Sponsored Study of CPX-351 in Combination With Ivosidenib for Patients With IDH1 Mutated Acute Myeloid Leukemia or High-Risk MDS","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2\n* IDH1-R132 mutated disease status as assessed by local laboratory. 2HG-producing IDH1 variants outside of R132 (i.e. R100) may be eligible after discussion with the principal investigator (PI)\n* Treatment naive or relapsed\u002Frefractory AML who are eligible for intensive chemotherapy. Patients with high-risk MDS or MPN (defined as International Prognostic Scoring System Revised \\[IPSS-R\\] score ≥ 4 or dynamic \\[D\\]-IPSS ≥ 3) may also be eligible after discussion with the PI\n* Adequate hepatic function (direct bilirubin ≤ 2 x upper limit of normal (ULN), Alanine aminotransferase (ALT) and\u002For aspartate aminotransferase (AST) ≤ 3 x ULN unless deemed to be related to underlying leukemia\n* Adequate renal function including creatinine clearance ≥ 30 ml\u002Fmin based on the Cockcroft-Gault equation.\n* Willing and able to provide informed consent\n* In the absence of rapidly proliferative disease, the interval from prior treatment to time of initiation will be at least 7 days for cytotoxic or non-cytotoxic (immunotherapy) agents.\n* Male subjects must agree to refrain from unprotected sex and sperm donation from initial study drug administration until 90 days after the last dose of study drug\n\nExclusion Criteria:\n\n* Patients who have previously received CPX-351.\n* Patients with any concurrent uncontrolled clinically significant medical condition including infection, laboratory abnormality, or psychiatric illness, which could place the patient at unacceptable risk of study treatment.\n* The use of other chemotherapeutic agents or anti-leukemic agents is not permitted during study with the following exceptions (1) intrathecal chemotherapy for prophylactic use or for controlled CNS leukemia. (2) use of hydroxyurea, and\u002For cytarabine (1 or 2 doses; up to 2 g\u002Fm2) for patients with rapidly proliferative disease is allowed before the start of study therapy.\n* Patients with active graft-versus-host-disease (GVHD) status post stem cell transplant (patients without active GVHD on chronic suppressive immunosuppression and\u002For phototherapy for chronic skin GVHD are permitted after discussion with the PI).\n* Patients with any severe gastrointestinal or metabolic condition which could interfere with the absorption of oral study medications.\n* Patients with symptomatic congestive heart failure (NYHA Class III or IV), unstable angina, or an ejection fraction \\\u003C 45%.\n* Patients with prior anthracycline exposure of \\> 360 mg\u002Fm2 daunorubicin (or equivalent), or \\> 210 mg\u002Fm2 daunorubicin (or equivalent) in patients with prior mediastinal radiation.\n* QTc interval using Fridericia's formula (QTcF) \\> 470 msec. A prolonged QTc interval in the setting of right bundle branch block is permitted after discussion with the PI.\n* Nursing women, women of childbearing potential (WOCBP) with positive urine or serum pregnancy test, or women of childbearing potential who are not willing to maintain adequate contraception\n\n  a. Appropriate highly effective method(s) of contraception include oral or injectable hormonal birth control, IUD, and double barrier methods (for example a condom in combination with a spermicide).\n* Subjects with a known medical history of progressive multifocal leukoencephalopathy (PML).\n* Subjects taking strong CYP3A4 inducers are excluded from the study unless they can be transferred to other medications within ≥ 5 half-lives prior to dosing\n* Patients with a diagnosis of acute promyelocytic leukemia (APL).\n* Unresolved toxicities \\> grade 1 from prior treatment including chemotherapy, targeted therapy, immunotherapy, experimental agents, radiation, or surgery.",{"count":157,"type":22},[105],"This phase II trial investigates how well CPX-351 and ivosidenib work in treating patients with acute myeloid leukemia or high-risk myelodysplastic syndrome that has IDH1 mutation. The safety of this drug combination will also be studied. IDH1 is a type of genetic mutation (change). Chemotherapy drugs, such as CPX-351, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Ivosidenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. The purpose of this trial is to learn if CPX-351 in combination with ivosidenib can help to control IDH1-mutated acute myeloid leukemia or high-risk myelodysplastic syndrome.",[246,57,247,29,84],"Acute Myeloid Leukemia With Gene Mutations","Myeloproliferative Neoplasm",{"date":249,"type":34},"2026-06-12",{"date":251,"type":34},"2020-12-30",{"date":232,"type":22},{"name":254,"class":68},"M.D. Anderson Cancer Center",{"id":256,"slug":257,"hasResults":12,"nctId":258,"briefTitle":259,"officialTitle":260,"acronym":4,"eligibilityCriteria":261,"healthyVolunteers":12,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":262,"targetDuration":4,"studyType":23,"phases":264,"briefSummary":265,"conditions":266,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":272,"startDateStruct":273,"completionDateStruct":275,"leadSponsor":277,"locationsCount":69},"100366159","phase-1-cladribine-idarubicin-cytarabine-and-quizartinib-in-treating-patients-with-newly-diagnosed-relapsed-or-refractory-acute-myeloid-leukemia-or-high-risk-myelodysplastic-syndrome-100366159","NCT04047641","Cladribine, Idarubicin, Cytarabine, and Quizartinib in Treating Patients With Newly Diagnosed, Relapsed, or Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome","A Combination of Cladribine, Idarubicin, Cytarabine (CLIA) and Quizartinib for the Treatment of Patients With Newly Diagnosed or Relapsed\u002FRefractory Acute Myeloid Leukemia (AML) and High-Risk Myelodysplastic Syndrome (MDS))","Inclusion Criteria:\n\n* Diagnosis of\n\n  * AML (World Health Organization \\[WHO\\] classification definition of \\>= 20% blasts, excluding Acute promyelocytic leukemia),\n  * Acute biphenotypic leukemia or\n  * High-risk MDS (\\> 10% bone marrow blasts)\n* Frontline cohort: Patients aged 18 to 65 years\n* Relapse cohort: Patients aged \\>=18 years old\n* Patients may be newly diagnosed (Frontline cohort) or with prior therapy (Relapsed cohort) as follows:\n\n  * For frontline cohort: Patients must be chemonaive, i.e., not have received any chemotherapy (except hydroxyurea \\[Hydrea\\] \\[no dose limit\\], tretinoin \\[atra\\] \\[no dose limit\\] or ara-C \\[one or two doses (max 2 gr\u002Fm\\^2 per dose)\\] for transient control of hyperleukocytosis) for AML or MDS. They may have received hypomethylating agents for prior MDS and transfusions, hematopoietic growth factors or vitamins. Temporary prior measures such as apheresis or Hydrea are allowed\n  * For relapsed cohort: Patients with previously treated, relapsed or refractory AML, acute biphenotypic leukemia or high-risk MDS (\\> 10% bone marrow blasts)\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 2\n* Creatinine \\\u003C 1.5 mg\u002Fdl\n* Total bilirubin \\\u003C 1.5 mg\u002FdL, unless increase is due to hemolysis or congenital disorder\n* Transaminases (serum glutamate pyruvate transaminase \\[SGPT\\]) \\\u003C 2.5 x upper limit of normal (ULN)\n* Potassium, magnesium, and calcium (normalized for albumin) levels should be at least within institutional normal limits\n* Ability to take oral medication\n* Ability to understand and provide signed informed consent\n* Baseline test of left ventricular ejection fraction \\>= 50%\n* Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within 7 days\n* WOCBP must use appropriate method(s) of contraception such as oral contraceptive pills (OCP), birth control shots, intrauterine device (IUD) etc. WOCBP should use an adequate method to avoid pregnancy until 30 days after the last dose of investigational drug. Men must agree not to father a child and agree to use a condom if his partner is of child bearing potential. Women who are not of childbearing potential (ie, who are postmenopausal or surgically sterile) as well as men with known azoospermia do not require contraception\n* Patients with isolated extramedullary myeloid neoplasm will be eligible\n\nExclusion Criteria:\n\n* Any coexisting medical condition that in the judgment of the treating physician is likely to interfere with study procedures or results\n* Breastfeeding women\n* Patients with current active malignancies or any remission for \\\u003C 6 months, except patients with carcinoma in situ or with non-melanoma skin cancer who may be in remission for less than 6 months or have active disease\n* Active clinically serious and uncontrolled infection. Patients with recent infections must have no temperature of \\>= 101 degrees Fahrenheit (F) for at least 48 hours (hrs) (before first dose, day 1)\n* Patients with known significant impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of quizartinib\n* Documented active central nervous system leukemia (patients with history of central nervous system \\[CNS\\] leukemia without active disease are allowed)\n* Patients with a known confirmed diagnosis of human immunodeficiency virus (HIV) infection or active viral hepatitis\n* Patients who have had any major surgical procedure within 14 days of day 1\n* Impaired cardiac function including any of the following:\n\n  * Screening electrocardiography (ECG) with a corrected QT (QTc) \\> 450 msec. The QTc interval will be calculated by Fridericia's correction factor (QTcF). The QTcF will be derived from the average QTcF in triplicate. Patients are excluded if they have QTcF \\>= 450. Subjects with prolonged QTcF interval in the setting of RBBB (right bundle branch block) may participate upon review and approval by the medical monitor. RBBB for patients' triplicate electrocardiograms (EKGs) can show false QTc prolongation; therefore, the cardiology collaborator for this study will manually review to provide an accurate reading of the QTc\n  * Patients with congenital long QT syndrome\n  * Sustained ventricular tachycardia requiring medical intervention\n  * Any history of clinically significant ventricular fibrillation or torsades de pointes\n  * Known history of second or third degree heart block (may be eligible if the patient currently has a pacemaker)\n  * Heart rate of \\\u003C 50\u002Fminute on pre-entry ECG\n  * Left bundle branch block\n  * Right bundle branch block + left anterior hemiblock (bifascicular block)\n  * Patients with myocardial infarction or unstable angina within 6 months prior to starting study drug\n  * Congestive heart failure (CHF) New York (NY) Heart Association class III or IV\n  * Atrial fibrillation documented within 2 weeks prior to first dose of study drug\n  * Known family history of congenital long QT syndrome\n  * Patients who are actively taking a strong CYP3A4 inducing medication",{"count":263,"type":22},80,[54,105],"This phase I\u002FII trial studies the side effects and how well cladribine, idarubicin, cytarabine, and quizartinib work in treating patients with acute myeloid leukemia or high-risk myelodysplastic syndrome that is newly diagnosed, has come back (relapsed), or does not respond to treatment (refractory). Drugs used in chemotherapy, such as cladribine, idarubicin, and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Quizartinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving quizartinib with cladribine, idarubicin, and cytarabine may help to control acute myeloid leukemia or high-risk myelodysplastic syndrome.",[28,267,268,269,29,270,84,271],"Blasts 20 Percent or More of Bone Marrow Nucleated Cells","High Risk Myelodysplastic Syndrome","Recurrent Acute Biphenotypic Leukemia","Recurrent High Risk Myelodysplastic Syndrome","Refractory High Risk Myelodysplastic Syndrome",{"date":249,"type":34},{"date":274,"type":34},"2019-10-22",{"date":276,"type":22},"2027-12-31",{"name":254,"class":68},{"id":279,"slug":280,"hasResults":12,"nctId":281,"briefTitle":282,"officialTitle":283,"acronym":4,"eligibilityCriteria":284,"healthyVolunteers":12,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":285,"targetDuration":4,"studyType":23,"phases":287,"briefSummary":288,"conditions":289,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":290,"startDateStruct":291,"completionDateStruct":293,"leadSponsor":295,"locationsCount":69},"100440040","phase-1-astx727-venetoclax-and-gilteritinib-for-the-treatment-of-newly-diagnosed-relapsed-or-refractory-flt3-mutated-acute-myeloid-leukemia-or-high-risk-myelodysplastic-syndrome-100440040","NCT05010122","ASTX727, Venetoclax, and Gilteritinib for the Treatment of Newly Diagnosed, Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome","A Phase I\u002FII Study of ASTX727, Venetoclax, and Gilteritinib for Patients With Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome With an Activating FLT3 Mutation","Inclusion Criteria:\n\n* Diagnosis:\n\n  * Phase I cohort: Adults \\>= 18 years with relapsed\u002Frefractory FLT3-mutated AML or myelodysplastic syndrome (MDS) that is intermediate-2 or high-risk by the International Prognostic Scoring System\n  * Phase II cohort A: Adults \\>= 18 years with newly diagnosed FLT3-mutated AML. Patients should meet the following criteria:\n\n    * Confirmed newly diagnosed AML with FLT3 mutation\n    * Ineligible for induction therapy defined as\n\n      * Either age \\>= 75\n      * Or 18-74 with at least one comorbidity (congestive heart failure \\[CHF\\] requiring therapy or ejection fraction \\[EF\\] =\\\u003C 50%, diffusion capacity of the lung for carbon monoxide \\[DLCO\\] =\\\u003C 65% or forced expiratory volume in 1 second \\[FEV1\\] =\\\u003C 65%, or Eastern Cooperative Oncology Group \\[ECOG\\] 2 or 3, or other significant co-morbidity precluding use of cytotoxic chemotherapy as approved by the principal investigator (PI)\n  * Phase II cohort B: Adults \\>= 18 years with relapsed\u002Frefractory FLT3-mutated AML or MDS that is intermediate-2 or high-risk by the International Prognostic Scoring System who have received 1 prior therapy\n  * For all cohorts, patients with either FLT3-ITD or FLT3 D835 mutations will be eligible\n* Performance status =\\\u003C 3 (Eastern Cooperative Oncology Group \\[ECOG\\] scale)\n* Total serum bilirubin =\\\u003C 2.5 x upper limit of normal (ULN), unless due to Gilbert's syndrome, hemolysis or the underlying leukemia approved by the PI\n* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) =\\\u003C 3 x ULN, unless due to the underlying leukemia approved by the PI\n* Creatinine clearance \\>= 30 mL\u002Fmin\n* Ability to swallow\n* Signed informed consent\n* Hydroxyurea or one dose of cytarabine up to 1000 mg is allowed to reduce the white blood cell (WBC) to less than 25 x 10\\^9\u002FL prior to initiation of study treatment\n\nExclusion Criteria:\n\n* Prior therapies\n\n  * Phase I cohort: No restriction based on prior therapies\n  * Phase II cohort A: Patients with prior therapy for AML are not eligible. Prior therapy for antecedent hematologic disorder is allowed including prior hypomethylating agent (HMA) therapy for MDS. Prior hydroxyurea or cytarabine given for purposes of cytoreduction is also allowed. Prior all trans-retinoic acid given for presumed acute promyelocytic leukemia is also allowed\n  * Phase II cohort B: Patients with \\>= 3 prior lines of therapy are not eligible. Stem cell transplantation, treatment given only for cytoreductive purposes (e.g. hydroxyurea), and growth factors do not count as lines of therapy for this purpose. Prior therapy with venetoclax and gilteritinib is allowed\n* Patients suitable for and willing to receive intensive induction chemotherapy (for Phase II cohort A only)\n* Congenital long QT syndrome or corrected QT (QTc) \\> 450 msec. Repeat electrocardiograms (EKGs) after correction of electrolytes or discontinuation of QT prolonging medications are allowed to meet entry criteria\n* Active serious infection not controlled by oral or intravenous antibiotics (e.g. persistent fever or lack of improvement despite antimicrobial treatment)\n* Active grade III-V cardiac failure as defined by the New York Heart Association Criteria\n* Active central nervous system leukemia\n* Known hepatitis B surface antigen seropositive or known or suspected active hepatitis C infection\n\n  * Note: Patients who have isolated positive hepatitis B core antibody (i.e., in the setting of negative hepatitis B surface antigen and negative hepatitis B surface antibody) must have an undetectable hepatitis B viral load. Patients who have positive hepatitis C antibody may be included if they have an undetectable hepatitis C viral load\n* Patients with a prior or concurrent malignancy whose natural history or treatment is not anticipated to interfere with the safety or efficacy assessment of the investigational regimen may be included only after discussion with the PI\n* Consumed strong inducer of CYP3A or p-glycoprotein within 3 days of study enrollment. Agents include but are not limited to: carbamazepine, phenytoin, rifampin, and St. John's wart\n* Treatment with any investigational antileukemic agents or chemotherapy agents in the last 7 days before study entry, unless full recovery from side effects has occurred or patient has rapidly progressive disease judged to be life-threatening by the investigator. Prior recent treatment with corticosteroids, hydroxyurea and\u002For cytarabine (given for cytoreduction) permitted. Use of hydroxyurea or one dose cytarabine to reduce WBC below 25 prior to initiation of study treatment is recommended\n* Pregnant women will not be eligible; women of childbearing potential should have a negative pregnancy test prior to entering on the study and be willing to use effective methods of contraception throughout the study period and for at least 6 months after the last dose of study drugs. Women do not have childbearing potential if they have had a hysterectomy or are postmenopausal without menses for 12 months. In addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential and should practice an effective method of birth control throughout the study period and for at least 4 months after the last dose of study drugs. Lactating women (or those planning to breastfeed) should not breastfeed during treatment of gilteritinib and for at least 2 months after the last dose of gilteritinib\n* Medical, psychiatric, cognitive or other conditions that compromise the patient's ability to understand the patient information, to give informed consent, to comply with the study protocol or to complete the study",{"count":286,"type":22},42,[54,105],"This phase I\u002FII trial studies the best dose of gilteritinib given together with ASTX727 and venetoclax and the effect of ASTX727, venetoclax, and gilteritinib in treating patients with FLT3-mutated acute myeloid leukemia that is newly diagnosed, has come back (relapsed) or does not respond to treatment (refractory) or high-risk myelodysplastic syndrome. Chemotherapy drugs, such as ASTX727, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Gilteritinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving ASTX727, venetoclax, and gilteritinib may help to control the disease.",[28,57,29,84],{"date":228,"type":34},{"date":292,"type":34},"2021-07-08",{"date":294,"type":22},"2028-01-30",{"name":254,"class":68},{"id":297,"slug":298,"hasResults":12,"nctId":299,"briefTitle":300,"officialTitle":301,"acronym":4,"eligibilityCriteria":302,"healthyVolunteers":12,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":303,"targetDuration":4,"studyType":23,"phases":305,"briefSummary":306,"conditions":307,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":308,"lastUpdatePostDateStruct":309,"startDateStruct":310,"completionDateStruct":312,"leadSponsor":314,"locationsCount":69},"100583060","phase-1-genetically-engineered-cells-cd83-car-t-cells-for-the-treatment-of-relapsed-or-refractory-acute-myeloid-leukemia-100583060","NCT06871410","Genetically Engineered Cells (CD83 CAR T Cells) for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia","CD83 CAR T in Relapsed or Refractory Acute Myeloid Leukemia (AML): A Phase I Trial","Inclusion Criteria:\n\n* Age ≥ 18 years old.\n* Karnofsky performance status score ≥ 70%.\n* Relapsed or refractory AML based upon ELN 2022 criteria.\n* Creatinine clearance: ≥ 40 mL\u002Fmin (Cockroft-Gault).\n* Total bilirubin: ≤ 2mg\u002FdL except for patients with Gilbert's syndrome, hemolysis, or related to disease.\n* Aspartate aminotransferase (AST) and alanine transaminase (ALT) \\\u003C 3.0 x upper limit of normal (ULN).\n* Left ventricular (LV) ejection fraction: \\> 45% and be free of symptomatic congestive heart failure or uncontrolled arrhythmia.\n* Oxygen (O2) saturation: ≥ 92% on room air without needs for supplemental O2.\n* Absolute lymphocyte count: ≥ 0.2 x 10\\^9\u002FL, HCT of ≥ 27% and platelets of ≥ 20 x 10\\^9\u002FL. Transfusion support is allowed to meet HCT and platelet parameters prior to apheresis.\n* Life expectancy ≥12 weeks from the time of enrollment, per clinical judgment.\n* Negative serum pregnancy test in females of child-bearing potential (FOCBP). FOCBP is defined as any female who has experienced menarche and who has not undergone successful surgical sterilization or who is not postmenopausal.\n* If history of allogeneic HCT, must have completed transplant at least 3 months prior, be off immunosuppression, including ruxolitinib, at least 2 weeks prior to apheresis, and have no evidence of GVHD requiring treatment at enrollment.\n* Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry and for 12 months following duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n* Participants must be considered preliminarily eligible for an allogeneic hematopoietic cell transplantation, with potential donors identified per a transplant and cellular therapy consult at Roswell Park Comprehensive Cancer Center.\n* Participant must understand the investigational nature of this study and sign an Independent Ethics Committee\u002FInstitutional Review Board approved written informed consent form prior to receiving any study related procedure.\n\nExclusion Criteria:\n\n* Concomitant systemic glucocorticoid use at a dose equivalent to \\> 10 mg daily prednisone at the time of apheresis and\u002For within 4 weeks of CD83 CAR T infusion for any reasons other than GVHD.\n* Diagnosis of acute promyelocytic leukemia (APL; AML M3 by French-American-British \\[FAB\\] classification).\n* Active central nervous system (CNS) leukemia; patients with history of CNS leukemia in complete response (CR) are eligible.\n* Patients enrolled in another investigational therapy protocol for their disease within 14 days or 5 half-lives prior to leukapheresis, whichever is shorter.\n* Patients requiring agents or any treatments other than hydroxyurea, single agent cytarbine,hypomethylating agents with or without ventoclax and\u002For targeted agents (i.e., FLT3, IDH2 or IDH1 inhibitors) to control blast counts within 14 days or 5 half-lives (whichever is shorter) prior to lymphodepletion.\n* Ongoing uncontrolled serious infection, pulmonary disease or psycho\u002Fsocial concerns.\n* HIV seropositivity or active hepatitis B or C infection within (defined by positive polymerase chain reaction \\[PCR\\]) 4 weeks of enrollment.\n* Other active malignancy within 2 years of study entry, except for basal cell cancer of skin, cervical cancer treated surgically with curative intent or localized prostate cancer managed with observational approach.\n* Active grade II-IV acute GVHD in patients with relapsed AML after HCT requiring treatment.\n* Prior solid organ transplant.\n* Active autoimmune disease requiring immunosuppressive therapy.\n* Pregnant or nursing female participants.\n* Unwilling or unable to follow protocol requirements.\n* Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug.",{"count":304,"type":22},26,[54],"This phase I trial tests the safety, side effects, and best dose of genetically engineered cells (CD83 chimeric antigen receptor \\[CAR\\] T cells) in treating patients with acute myeloid leukemia (AML) that has come back after a period of improvement (relapsed) or has not responded to previous treatment (refractory). CD83 is a protein that is found on AML blasts. Blasts are abnormal immature white blood cells that can multiply uncontrollably: filling up the bone marrow and preventing the production of other cells important for survival. CD83 CAR T cells represent a new cell therapy to eliminate AML blasts, while avoiding the risk for graft versus host disease (GVHD) after stem cell transplant to replace bone marrow or, tumor toxicity like myeloid aplasia where the body's own immune system causes damage to the bone marrow stem cells. Therefore, human CD83 CAR T cells are a promising cell-based approach to preventing two critical complications of stem-cell transplant - GVHD and relapse. Giving CD83 CAR T cells may be safe, tolerable, and\u002For effective in treating patients with relapsed or refractory AML.",[29,84],"2026-06-08",{"date":226,"type":34},{"date":311,"type":34},"2026-03-02",{"date":313,"type":22},"2028-04-01",{"name":315,"class":68},"Roswell Park Cancer Institute",{"id":317,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":318,"targetDuration":4,"studyType":23,"phases":319,"briefSummary":26,"conditions":320,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":321,"lastUpdatePostDateStruct":322,"startDateStruct":324,"completionDateStruct":325,"leadSponsor":326,"locationsCount":69},"100594686",{"count":21,"type":22},[25],[28,29],"2026-05-29",{"date":323,"type":34},"2026-06-02",{"date":36,"type":34},{"date":38,"type":22},{"name":40,"class":41},{"id":328,"slug":329,"hasResults":12,"nctId":330,"briefTitle":331,"officialTitle":331,"acronym":4,"eligibilityCriteria":332,"healthyVolunteers":12,"sex":17,"minAge":333,"maxAge":334,"enrollmentInfo":335,"targetDuration":4,"studyType":23,"phases":337,"briefSummary":338,"conditions":339,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":359,"lastUpdatePostDateStruct":360,"startDateStruct":362,"completionDateStruct":364,"leadSponsor":366,"locationsCount":69},"100264904","phase-2-personalized-nk-cell-therapy-in-cbt-100264904","NCT02727803","Personalized NK Cell Therapy in CBT","Inclusion Criteria:\n\n* Patients must have one of the following hematologic malignancies: acute myelogenous leukemia (AML), induction failure, high-risk for relapse first remission (with intermediate-risk or high-risk cytogenetics including complex karyotype, abnormal \\[abn\\]\\[3q\\], -5\u002F5q-, -7\u002F7q-, abn\\[12p\\], abn\\[17p\\], myeloid\u002Flymphoid or mixed-lineage leukemia \\[MLL\\] gene re-arrangement and t \\[6;9\\]47, fms related tyrosine kinase 3 \\[flt3\\] mutation positive and\u002For evidence of minimal residual disease by flow cytometry), secondary leukemia from prior chemotherapy and\u002For arising from myelodysplastic syndromes (MDS), any disease beyond first remission\n* Myelodysplastic syndrome (MDS): Primary or therapy related, including patients that will be considered for transplant; these include any of the following categories: 1) revised International Prognostic Scoring System (IPSS) intermediate and high risk groups, 2) malondialdehyde (MDA) with transfusion dependency, 3) failure to respond or progression of disease on hypomethylating agents, 4) refractory anemia with excess of blasts, 5) transformation to acute leukemia, 6) chronic myelomonocytic leukemia, 7) atypical MDS\u002Fmyeloproliferative syndromes, 8) complex karyotype, abn(3g), -5\u002F5g-, -7\u002F7g-, abn(12p), abn(17p)\n* Acute lymphoblastic leukemia (ALL): Induction failure, primary refractory to treatment (do not achieve complete remission after first course of therapy) or are beyond first remission including second or greater remission or active disease; patients in first remission are eligible if they are considered high risk, defined as any of the following detected at any time: with translocations 9;22 or 4;11, hypodiploidy, complex karyotype, secondary leukemia developing after cytotoxic drug exposure, and\u002For evidence of minimal residual disease or acute biphenotypic leukemia, or double hit non-Hodgkin's lymphoma\n* Non-Hodgkin's lymphoma (NHL) in second or third complete remission, or relapse (including relapse post autologous hematopoietic stem cell transplant); relapsed double hit lymphomas; patients with options for treatment that are known to be curative are not eligible\n* Small lymphocytic lymphoma (SLL), or chronic lymphocytic leukemia (CLL) with progressive disease following a minimum of two lines of standard therapy\n* Chronic myeloid leukemia (CML) second chronic phase or accelerated phase\n* Hodgkin's disease (HD): Induction failures, after first complete remission, or relapse (including relapse post autologous hematopoietic stem cell transplant), or those with active disease\n* Multiple myeloma: stage II or III, symptomatic, secretory multiple myeloma requiring treatment\n* A person (such as a haploidentical family member) or unit of cord blood must be identified as a source of back-up cells source in case of engraftment failure\n* Patient age criteria: age \\>= 15 and =\\\u003C 45 years (myeloablative regimen 1; age \\>= 15 and =\\\u003C 80 years (nonmyeloablative regimen 2) at the discretion of the investigator(s); age \\>= 15 and =\\\u003C 80 years old that in the opinion of the investigator(s) would preclude myeloablative therapy may receive reduced intensity regimen 3\n* Performance score of at least 60% by Karnofsky\n* Left ventricular ejection fraction of at least 40% (myeloablative regimen 1, reduced intensity regimen 3)\n* Left ventricular ejection fraction of at least 30% (nonmyeloablative regimen 2)\n* Pulmonary function test (PFT) demonstrating an adjusted diffusion capacity of least 50% predicted value for hemoglobin concentration (myeloablative regimen 1, reduced intensity regimen 3)\n* Serum creatinine within normal range, or if serum creatinine outside normal range, then renal function (measured or estimated creatinine clearance or glomerular filtration rate \\[GFR\\]) \\> 40mL\u002Fmin\u002F1.73 m\\^2\n* Serum glutamate pyruvate transaminase (SGPT)\u002Fbilirubin \\\u003C to 2.0 x normal (myeloablative regimen 1), reduced intensity regimen 3; SGPT\u002Fbilirubin \\\u003C to 4.0 x normal (nonmyeloablative regimen 2)\n* Negative beta human chorionic gonadotropin (HCG) test in a woman with child bearing potential defined as not post-menopausal for 12 months\n* Patients with options for treatment that are known to be curative are not eligible\n* Patients enrolled in this study may be enrolled on other supportive care investigational new drug (IND) studies at the discretion of the principal investigator (PI)\n\nExclusion Criteria:\n\n* Human immunodeficiency virus (HIV) positive; HIV results will be determined by nucleic acid testing\n* Uncontrolled serious medical condition such as persistent septicemia despite adequate antibiotic therapy, decompensated congestive heart failure despite cardiac medications or pulmonary insufficiency requiring intubation (excluding primary disease for which cord blood \\[CB\\] transplantation is proposed), or psychiatric condition that would limit informed consent\n* Active central nervous system (CNS) disease in patient with history of CNS malignancy\n* Availability of appropriate, willing, human leukocyte antigen (HLA)-matched related stem cell donor","15 Years","80 Years",{"count":336,"type":22},100,[105],"This phase II clinical trial studies how well personalized natural killer (NK) cell therapy works after chemotherapy and umbilical cord blood transplant in treating patients with myelodysplastic syndrome, leukemia, lymphoma or multiple myeloma. This clinical trial will test cord blood (CB) selection for human leukocyte antigen (HLA)-C1\u002Fx recipients based on HLA-killer-cell immunoglobulin-like receptor (KIR) typing, and adoptive therapy with CB-derived NK cells for HLA-C2\u002FC2 patients. Natural killer cells may kill tumor cells that remain in the body after chemotherapy treatment and lessen the risk of graft versus host disease after cord blood transplant.",[340,341,108,161,342,343,344,345,110,346,347,348,349,57,111,350,351,352,29,353,354,355,112,356,357,358],"Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive","Acute Biphenotypic Leukemia","Acute Myeloid Leukemia With Myelodysplasia-Related Changes","Acute Myeloid Leukemia With Variant MLL Translocations","B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1","Chemotherapy-Related Leukemia","Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive","High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements","ISS Stage II Plasma Cell Myeloma","ISS Stage III Plasma Cell Myeloma","Myelodysplastic Syndrome With Gene Mutation","Myelodysplastic\u002FMyeloproliferative Neoplasm","Previously Treated Myelodysplastic Syndrome","Recurrent Adult Acute Myeloid Leukemia","Recurrent Hodgkin Lymphoma","Recurrent Non-Hodgkin Lymphoma","Refractory Adult Acute Lymphoblastic Leukemia","Secondary Acute Myeloid Leukemia","Therapy-Related Myelodysplastic Syndrome","2026-05-20",{"date":361,"type":34},"2026-05-22",{"date":363,"type":34},"2016-05-19",{"date":365,"type":22},"2027-05-31",{"name":254,"class":68},{"id":368,"slug":369,"hasResults":12,"nctId":370,"briefTitle":371,"officialTitle":372,"acronym":4,"eligibilityCriteria":373,"healthyVolunteers":12,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":374,"targetDuration":4,"studyType":23,"phases":376,"briefSummary":377,"conditions":378,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":379,"lastUpdatePostDateStruct":380,"startDateStruct":381,"completionDateStruct":383,"leadSponsor":385,"locationsCount":69},"100421944","phase-1-decitabinecedazuridine-and-venetoclax-in-combination-with-ivosidenib-or-enasidenib-for-the-treatment-of-relapsed-or-refractory-acute-myeloid-leukemia-100421944","NCT04774393","Decitabine\u002FCedazuridine and Venetoclax in Combination With Ivosidenib or Enasidenib for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia","Phase 1b\u002F2 Study of Oral Decitabine\u002FCedazuridine (ASTX727) and Venetoclax in Combination With the Targeted Mutant IDH1 Inhibitor Ivosidenib or the Targeted Mutant IDH2 Inhibitor Enasidenib","Inclusion Criteria:\n\n* Patients with a diagnosis of relapsed or refractory acute myeloid leukemia (AML) (including biphenotypic or bilineage leukemia including a myeloid component or isolated extramedullary AML); OR\n* Patients (\\> 60 year old) with newly diagnosed AML not eligible for intensive chemotherapy are also eligible\n* To be considered not eligible for intensive chemotherapy, participants must be defined by the following: Age 75 years or older, or Age 18 to 74 years with at least one of the following comorbidities:\n* Severe cardiac disorder (eg, congestive heart failure requiring treatment, ejection fraction ≤50%, or chronic stable angina).\n* Severe pulmonary disorder (eg, DLCO ≤65% or forced expiratory volume in 1 second \\[FEV1\\] ≤65%).\n* Creatinine clearance ≥30 mL\u002Fmin to \\\u003C45 mL\u002Fmin.\n* Moderate hepatic impairment with total bilirubin \\>1.5 to ≤3.0 × upper limit of normal (ULN)\n* ECOG performance status of 2 or 3\n* Age \\>= 18 years\n* Subjects must have documented IDH1 or IDH2 gene mutation\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 2\n* Adequate renal function including creatinine \\\u003C 2 unless related to the disease\n* Direct bilirubin \\\u003C 2 x upper limit of normal (ULN) unless increase is due to Gilbert's disease or leukemic involvement\n* Aspartate aminotransferase (AST) and\u002For alanine aminotransferase (ALT) \\\u003C 3 x ULN unless considered due to leukemic involvement, in which case direct bilirubin or AST and\u002For ALT \\\u003C 5 x ULN will be considered eligible)\n* In the absence of rapidly proliferative disease, the interval from prior treatment to time of initiation will be at least 7 days for cytotoxic or non-cytotoxic (immunotherapy agent(s). Oral hydroxyurea and\u002For cytarabine (up to 2 g\u002Fm\\^2) for patients with rapidly proliferative disease is allowed before the start of study therapy, as needed, for clinical benefit and after discussion with the principle investigator (PI). Concurrent therapy for central nervous system (CNS) prophylaxis or continuation of therapy for controlled CNS disease is permitted\n* Male subjects who are sexually active with a women of childbearing potential (WOCBP) and who have not had vasectomies must be willing to use a barrier method of contraception and refrain from sperm donation from initial study drug until 90 days after last dose of study drug\n* Willing and able to provide informed consent\n\nExclusion Criteria:\n\n* Patients with t(15;17) karyotypic abnormality or acute promyelocytic leukemia (French-American-British \\[FAB\\] class M3-AML)\n* Patients with any concurrent uncontrolled clinically significant medical condition including life-threatening severe infection, or psychiatric illness, which could place the patient at unacceptable risk of study treatment\n* Patients with active graft-versus-host-disease (GVHD) status post stem cell transplant (patients without active GVHD on chronic suppressive immunosuppression and\u002For phototherapy for chronic skin GVHD are permitted after discussion with the PI)\n* Patients with any severe gastrointestinal or metabolic condition which could interfere with the absorption of oral study medications\n* Corrected QT (QTc) interval using Fridericia's formula (QTcF) \\>= 450 msec. Bundle branch block and prolonged QTc interval are permitted after discussion with the PI\n* Known active hepatitis B (HBV) or hepatitis C (HCV) infection or known human immunodeficiency virus (HIV) infection\n* Subject has a white blood cell count \\> 25 x 10\\^9\u002FL. (Note: Hydroxyurea is permitted to meet this criterion)\n* Nursing women, women of childbearing potential (WOCBP) with positive urine pregnancy test, or women of childbearing potential who are not willing to maintain adequate contraception\n\n  * Appropriate highly effective method(s) of contraception include oral or injectable hormonal birth control, intrauterine device (IUD), and double barrier methods (for example a condom in combination with a spermicide)",{"count":375,"type":22},84,[54,105],"This phase Ib\u002FII trials studies the side effects of decitabine\u002Fcedazuridine (ASTX727) and venetoclax in combination with ivosidenib or enasidenib, and how well they work in treating patients with acute myeloid leukemia that has come back (relapsed) or does not respond to treatment (refractory). ASTX727 is the combination of a fixed dose of 2 drugs, cedazuridine and decitabine. Cedazuridine may slow down how fast decitabine is broken down by the body, and decitabine may block abnormal cells or cancer cells from growing. Venetoclax may stop the growth of cancer cells by blocking BCL-2, a protein needed for cancer cell survival. Enasidenib and ivosidenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving decitabine\u002Fcedazuridine and venetoclax in combination with ivosidenib or enasidenib may help control acute myeloid leukemia.",[28,29,84],"2026-05-18",{"date":359,"type":34},{"date":382,"type":34},"2021-05-24",{"date":384,"type":22},"2027-11-29",{"name":254,"class":68},{"id":387,"slug":388,"hasResults":12,"nctId":389,"briefTitle":390,"officialTitle":391,"acronym":4,"eligibilityCriteria":392,"healthyVolunteers":12,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":393,"targetDuration":4,"studyType":23,"phases":395,"briefSummary":396,"conditions":397,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":379,"lastUpdatePostDateStruct":398,"startDateStruct":399,"completionDateStruct":401,"leadSponsor":403,"locationsCount":69},"100334039","phase-2-liposome-encapsulated-daunorubicin-cytarabine-and-venetoclax-in-treating-participants-with-relapsed-refractory-or-untreated-acute-myeloid-leukemia-100334039","NCT03629171","Liposome-encapsulated Daunorubicin-Cytarabine and Venetoclax in Treating Participants With Relapsed, Refractory or Untreated Acute Myeloid Leukemia","Phase II Study of CPX-351 in Combination With Venetoclax in Patients With Acute Myeloid Leukemia (AML)","Inclusion Criteria:\n\n* For the lead in phase: Patients \\>= 18 years of age with a diagnosis of relapsed and\u002For refractory AML will be eligible. Patients who have had prior treatment with venetoclax will be allowed to participate in the lead in phase and cohort A\n* For the dose expansion cohort A (relapsed\u002Frefractory \\[R\u002FR\\] AML): Patients \\>= 18 years of age with a diagnosis of relapsed and\u002For refractory AML will be eligible\n* For the dose expansion cohort B (de novo AML): Patients \\>= 18 years to 69 years of age; patients in this cohort must have received no prior therapy for AML\n* Prior therapy with hydroxyurea, hematopoietic growth factors, or tretinoin (ATRA) (for emergency use for stabilization) is allowed with no washout. A cumulative dose of ara-C of up to 3 g for emergency stabilization in patients with rapidly proliferating disease is also allowed provided it was administered \\> 48 hrs prior to enrollment\n* Bilirubin =\\\u003C 2 mg\u002FdL\n* Aspartate aminotransferase (AST) and\u002For alanine aminotransferase (ALT) =\\\u003C 3 x upper limit of normal (ULN) or \\\u003C 5 x ULN if related to leukemic involvement\n* Creatinine =\\\u003C 1.5 x ULN\n* Known cardiac ejection fraction of \\> or = 45% within the past 3 months\n* Eastern Cooperative Oncology Group (ECOG) performance status of =\\\u003C 2\n* A negative urine or serum pregnancy test is required within 1 week for all women of childbearing potential prior to enrolling on this trial. A woman of childbearing potential is defined as a woman who has not been naturally postmenopausal for at least 12 consecutive months, or who had no previous surgical sterilization\n* Patient must have the ability to understand the requirements of the study and signed informed consent. A signed informed consent by the patient or his legally authorized representative is required prior to their enrollment on the protocol\n\nExclusion Criteria:\n\n* Pregnant women are excluded from this study because the agents used in this study have the potential for teratogenic or abortifacient effects. Because there is a potential risk for adverse events in nursing infants secondary to treatment of the mother with the chemotherapy agents, breastfeeding should also be avoided\n* Uncontrolled intercurrent illness including, but not limited to active uncontrolled infection, symptomatic congestive heart failure (New York Heart Association \\[NYHA\\] class III or IV), unstable angina pectoris, clinically significant cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Patient with documented hypersensitivity to any of the components of the chemotherapy program\n* Patients with acute promyelocytic leukemia (M3) or core-binding factor AML\n* Patients with active central nervous system (CNS) leukemia are excluded since the antileukemia activity of the treatment components against CNS leukemia are not known\n* Men and women of childbearing potential who do not practice contraception. Women of childbearing potential and men must agree to use contraception prior to study entry and for the duration of study participation\n* Prior treatment with CPX-351 or venetoclax. Patients with prior treatment with venetoclax will be allowed in patients with relapsed\u002Frefractory (R\u002FR) disease including those in the lead-in phase as well as those in cohort A",{"count":394,"type":22},52,[105],"This phase II trial studies how well liposome-encapsulated daunorubicin-cytarabine and venetoclax work in treating participants with acute myeloid leukemia that has come back (relapsed), does not respond to treatment (refractory), or has not been treated (untreated). Drugs used in chemotherapy, such as liposome-encapsulated daunorubicin-cytarabine and venetoclax, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.",[29,84],{"date":359,"type":34},{"date":400,"type":34},"2018-10-29",{"date":402,"type":22},"2026-12-31",{"name":254,"class":68},{"id":405,"slug":406,"hasResults":12,"nctId":407,"briefTitle":408,"officialTitle":409,"acronym":4,"eligibilityCriteria":410,"healthyVolunteers":12,"sex":17,"minAge":50,"maxAge":411,"enrollmentInfo":412,"targetDuration":4,"studyType":23,"phases":414,"briefSummary":415,"conditions":416,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":379,"lastUpdatePostDateStruct":424,"startDateStruct":425,"completionDateStruct":427,"leadSponsor":429,"locationsCount":69},"100218005","phase-2-cladribine-idarubicin-cytarabine-and-venetoclax-in-treating-patients-with-acute-myeloid-leukemia-high-risk-myelodysplastic-syndrome-or-blastic-phase-chronic-myeloid-leukemia-100218005","NCT02115295","Cladribine, Idarubicin, Cytarabine, and Venetoclax in Treating Patients With Acute Myeloid Leukemia, High-Risk Myelodysplastic Syndrome, or Blastic Phase Chronic Myeloid Leukemia","Phase II Study of Cladribine Plus Idarubicin Plus Cytarabine (ARAC) in Patients With AML, HR MDS, or Myeloid Blast Phase of CML","Inclusion Criteria:\n\n1. Patients with a diagnosis of AML, Acute Biphenotypic Leukemia, or high risk MDS (\\>\u002F= 10% blasts or IPSS \\>\u002F= intermediate-2) will be eligible. Patients with CML in Myeloid Blast Phase are also eligible.\n2. For Frontline cohort (1 or 4): No prior potentially-curative therapy for leukemia. Prior therapy with hydroxyurea, hematopoietic growth factors, azacytidine, decitabine, ATRA, or a total dose of cytarabine up to 2g (for emergency use for stabilization) is allowed. Patients deemed able to receive venetoclax (ie. insurance clearance) will be assigned to Frontline cohort 4. Patients with secondary AMLwho have been treated for their antecedent myeloid neoplasm will be enrolled into the separate Secondary AML cohort.\n3. For Salvage cohort: Patients with previously treated, relapsed or refractory AML, Acute Biphenotypic Leukemia, or CML in Myeloid Blast Phase are eligible.\n4. Age \\\u003C\u002F= 65 years.\n5. Adequate organ function as defined below:\n\n   * liver function (bilirubin \\\u003C 2mg\u002FdL, AST and\u002For ALT \\\u003C3 x ULN - or \\\u003C5 x ULN if related to leukemic involvement)\n   * kidney function (creatinine \\\u003C 1.5 x ULN ).\n   * known cardiac ejection fraction of \\> or = 45% within the past 6 months\n6. ECOG performance status of ≤ 2.\n7. A negative urine pregnancy test is required within 1 week for all women of childbearing potential prior to enrolling on this trial.\n8. Patient must have the ability to understand the requirements of the study and signed informed consent. A signed informed consent by the patient is required prior to their enrollment on the protocol.\n\nExclusion Criteria:\n\n1. Pregnant women are excluded from this study because the agents used in this study have the potential for teratogenic or abortifacient effects. Because there is a potential risk for adverse events in nursing infants secondary to treatment of the mother with the chemotherapy agents, breastfeeding should also be avoided.\n2. Uncontrolled intercurrent illness including, but not limited to active uncontrolled infection, symptomatic congestive heart failure (NYHA Class III or IV), unstable angina pectoris, clinically significant cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n3. Patient with documented hypersensitivity to any of the components of the chemotherapy program.\n4. Men and women of childbearing potential who do not practice contraception. Women of childbearing potential and men must agree to use contraception prior to study entry and for the duration of study participation.","65 Years",{"count":413,"type":22},508,[105],"This phase II trial studies how well cladribine, idarubicin, cytarabine, and venetoclax work in patients with acute myeloid leukemia, high-risk myelodysplastic syndrome, or blastic phase chronic myeloid leukemia. Drugs used in chemotherapy, such as cladribine, idarubicin, cytarabine, and venetoclax, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.",[341,28,417,418,419,420,57,352,29,421,84,422,357,423],"Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive","Blasts 10 Percent or More of Bone Marrow Nucleated Cells","Blasts 10 Percent or More of Peripheral Blood White Cells","de Novo Myelodysplastic Syndrome","Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive","Refractory Chronic Myelogenous Leukemia, BCR-ABL1 Positive","Untreated Adult Acute Myeloid Leukemia",{"date":359,"type":34},{"date":426,"type":34},"2014-05-19",{"date":428,"type":22},"2030-05-31",{"name":254,"class":68},{"id":431,"slug":432,"hasResults":12,"nctId":433,"briefTitle":434,"officialTitle":435,"acronym":4,"eligibilityCriteria":436,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":334,"enrollmentInfo":437,"targetDuration":4,"studyType":23,"phases":438,"briefSummary":439,"conditions":440,"keywords":456,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":460,"lastUpdatePostDateStruct":461,"startDateStruct":462,"completionDateStruct":464,"leadSponsor":466,"locationsCount":69},"100310864","phase-1-ha-1-t-tcr-t-cell-immunotherapy-for-the-treatment-of-patients-with-relapsed-or-refractory-acute-leukemia-after-donor-stem-cell-transplant-100310864","NCT03326921","HA-1 T TCR T Cell Immunotherapy for the Treatment of Patients With Relapsed or Refractory Acute Leukemia After Donor Stem Cell Transplant","Phase I Study of Adoptive Immunotherapy With CD8+ and CD4+ Memory T Cells Transduced to Express an HA-1-Specific T Cell Receptor (TCR) for Children and Adults With Recurrent Acute Leukemia After Allogeneic Hematopoietic Stem Cell Transplantation (HCT)","Inclusion Criteria:\n\n* Subject age 0-80 years at the time of enrollment.\n* Subject must express HLA-A\\*0201\n* Subject must have the HA-1(H) genotype (RS\\_1801284: A\u002FG, A\u002FA)\n* Subject must have an adult donor for HCT who is adequately HLA matched by institutional standards (includes HLA-matched related or unrelated donors, and HLA-mismatched family donors, including haploidentical donors) and is either:\n\n  * HLA-A\\*0201 positive and HA-1(H) negative (RS\\_1801284: G\u002FG) or\n  * HLA-A\\*0201 negative\n* Subjects who are currently undergoing or who previously underwent allogeneic HCT for\n\n  * Acute myeloid leukemia (AML) of any subtype\n  * Acute lymphoid leukemia (ALL) of any subtype\n  * Mixed phenotype\u002Fundifferentiated\u002Fany other type of acute leukemia, including blastic plasmacytoid dendritic cell neoplasm\n  * Chronic myeloid leukemia with a history of blast crisis and:\n\n    * With relapse or refractory disease (\\>= 5% marrow blasts, or circulating blasts) at any time after HCT\n    * With persistent rising minimal residual disease (defined as detectable disease by morphology, flow cytometry, molecular or cytogenetic testing but \\\u003C 5% marrow blasts by morphology, no circulating blasts on \\>= 2 of two consecutive tests), refractory or ineligible for treatment with tyrosine kinase inhibitors at any time after HCT\n  * Myelodysplastic syndrome (MDS) of any subtype\n  * Chronic myelomonocytic leukemia (CMML)\n  * Juvenile myelomonocytic leukemia (JMML)\n* Subjects must be able to understand and be willing to give informed consent; decision-impaired adults may consent with their legally authorized representative; parent or legal representative will be asked to consent for subjects younger than 18 years old\n* Subjects must agree to participate in long-term follow-up for up to 15 years if they are enrolled in the study and receive T cell infusion\n* Subjects who have relapsed or have MRD after HCT may receive other agents for treatment of disease and remain eligible for the protocol\n* A specific performance status score is not required for enrolling on the protocol; a delay in infusion of the HA-1 TCR T cells may be required for subjects with low performance status\n\nDONOR SELECTION INCLUSION\n\n* Donor age \\>= 18 years\n* Donors must be able to give informed consent\n\nExclusion Criteria:\n\n* Medical or psychological conditions that would make the subject unsuitable candidate for cell therapy at the discretion of the principal investigator (PI)\n* Fertile subjects unwilling to use contraception during and for 12 months after treatment\n* Subjects with a life expectancy of \\\u003C 3 months of enrollment from coexisting disease other than leukemia\n* Subjects who have ongoing grade IV acute GVHD or severe chronic GVHD following most recent transplant. Exception: the principal investigator (PI) may make an exception on a case-by-case basis to include such a subject if there is doubt surrounding the GVHD diagnosis and\u002For sustained significant improvement in GVHD severity\n* The presence of organ toxicities will not necessarily exclude subjects from enrolling on the protocol at the discretion of the PI; however, a delay in the infusion of HA-1 TCR T cells may be required\n\nDONOR SELECTION EXCLUSION\n\n* Donors who are human immunodeficiency virus (HIV)-1, HIV-2, human T-lymphotropic virus (HTLV)-1, HTLV-2 seropositive or with active hepatitis B or hepatitis C virus infection\n* Unrelated donor residing outside of the United States of America (USA) unless the donor screening, testing and leukapheresis occur at an National Marrow Donor Program (NMDP)-affiliated and qualified donor center and are facilitated by the NMDP",{"count":42,"type":22},[54],"This phase I trial studies the side effects and best dose of CD4+ and CD8+ HA-1 T cell receptor (TCR) (HA-1 T TCR) T cells in treating patients with acute leukemia that persists, has come back (recurrent) or does not respond to treatment (refractory) following donor stem cell transplant. T cell receptor is a special protein on T cells that helps them recognize proteins on other cells including leukemia. HA-1 is a protein that is present on the surface of some peoples' blood cells, including leukemia. HA-1 T cell immunotherapy enables genes to be added to the donor cells to make them recognize HA-1 markers on leukemia cells.",[441,269,442,443,444,112,356,445,446,58,447,83,448,116,449,450,113,29,57,28,108,341,451,110,452,453,114,454,455],"Juvenile Myelomonocytic Leukemia","Recurrent Acute Undifferentiated Leukemia","Recurrent Childhood Acute Lymphoblastic Leukemia","Recurrent Childhood Acute Myeloid Leukemia","Blast Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive","Recurrent Blastic Plasmacytoid Dendritic Cell Neoplasm","Refractory Blastic Plasmacytoid Dendritic Cell Neoplasm","Acute Undifferentiated Leukemia","Recurrent Chronic Myeloid Leukemia, BCR-ABL1 Positive","Refractory Chronic Myeloid Leukemia, BCR-ABL1 Positive","Chronic Myeloid Leukemia","Minimal Residual Disease","Recurrent Chronic Myelomonocytic Leukemia","Leukemia","Chronic Myeloid Leukemia, BCR-ABL1 Positive",[457,458,459,454],"HA-1","TCR","Immunotherapy","2026-05-15",{"date":379,"type":34},{"date":463,"type":34},"2018-02-23",{"date":465,"type":22},"2028-07-16",{"name":67,"class":68},{"id":468,"slug":469,"hasResults":12,"nctId":470,"briefTitle":471,"officialTitle":472,"acronym":4,"eligibilityCriteria":473,"healthyVolunteers":474,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":475,"targetDuration":4,"studyType":23,"phases":476,"briefSummary":477,"conditions":478,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":481,"lastUpdatePostDateStruct":482,"startDateStruct":483,"completionDateStruct":485,"leadSponsor":487,"locationsCount":69},"100587459","phase-1-chemotherapy-decitabine-in-combination-with-flag-ida-and-total-body-irradiation-followed-by-donor-stem-cell-transplant-for-the-treatment-of-adults-with-myeloid-malignancies-at-high-risk-of-relapse-100587459","NCT06928662","Chemotherapy (Decitabine in Combination With FLAG-Ida) and Total-Body Irradiation Followed by Donor Stem Cell Transplant for the Treatment of Adults With Myeloid Malignancies at High Risk of Relapse","Sequential Decitabine in Combination With FLAG-Ida Followed Immediately by Reduced-Intensity Conditioning (RIC) Allogeneic Hematopoietic Cell Transplantation (DEC-FLAG-Ida\u002FRIC) for Adults With Myeloid Malignancies at High Risk of Relapse: A Phase 1\u002F2 Study","Inclusion Criteria:\n\n* Age ≥ 18 years with an HCT-co-morbidity index (CI) ≤ 5 for patients over 60 years.\n* AML (2022 World Health Organization \\[WHO\\] criteria) that is either primary refractory (as defined by failure of 2 cycles of 7+3-like chemotherapy, 1 cycle of high-dose cytarabine-based chemotherapy, or at least 2 cycles of venetoclax in combination with other therapies) or is in untreated or unsuccessfully treated first or subsequent relapse. Patients in morphologic remission (i.e. \\\u003C 5% blasts in the bone marrow) but evidence of minimal residual disease (MRD) by multiparameter flow cytometry, cytogenetics\u002Ffluorescence in situ hybridization (FISH), or molecular means will be eligible for trial participation. Patients with relapsed or refractory acute leukemia of ambiguous lineage (acute undifferentiated leukemia or mixed phenotype acute leukemia) that is either primary refractory or is in untreated or unsuccessfully treated first or subsequent relapse are also eligible.\n* MDS and CMML: Subjects with previously treated MDS and CMML, defined as prior treatment with at least one hypomethylating agent (hypomethylating agent \\[HMA\\]; azacitidine, decitabine and\u002For decitabine-cedazuridine) whose disease progressed, relapsed, or was refractory to HMA treatment as follows: 1) patients who have failed at least 4 cycles of monotherapy with azacitidine, decitabine or decitabine-cedazuridine, 2) patients who received at least 2 cycles of HMA in combination with another therapeutic agent. Subjects with MDS and CMML who failed at least 1 cycle of induction chemotherapy will be also eligible. Patients with MDS or CMML who progress to secondary AML will be eligible if they received at least 4 cycles of HMA alone or 2 cycles of HMA in combination with another therapeutic agent.\n* Patients may have previously received hypomethylating agents or chemotherapy with a mitoxantrone, idarubicin- or cladribine\u002Ffludarabine-based regimen for MDS or AML. If the patient has received cladribine-cytarabine-filgrastim-mitoxantrone (CLAG-M) or FLAG-Ida before and has been sensitive to this regimen, defined as MRD negative complete remission (CR) immediately after receiving the treatment and which lasts ≥ 1 year, eligibility will be determined on a case-by-case basis by the study principal investigator (PI).\n* The use of hydroxyurea prior to initiation of study treatment is allowed. Patients with symptoms\u002Fsigns of hyperleukocytosis, white blood cells (WBC) \\> 100,000\u002FμL or with concern for other complications of high tumor burden of high tumor dynamics (e.g. disseminated intravascular coagulation) can be treated with leukapheresis or may receive up to 2 doses of cytarabine (up to 500 mg\u002Fm\\^2 per dose) prior to start of study treatment.\n* Karnofsky score ≥ 70; Eastern Cooperative Oncology Group (ECOG) 0-1.\n* Adequate cardiac function defined as absence of decompensated congestive heart failure and\u002For uncontrolled arrhythmia and left ventricular ejection fraction ≥ 45%.\n* Bilirubin ≤ 2.5 x Institutional Upper Limit of Normal unless elevation is thought to be due to hepatic infiltration by AML, Gilbert's syndrome, or hemolysis\n* Adequate pulmonary function defined as absence of oxygen (O2) requirements and either diffusion capacity of the lung for carbon monoxide (DLCO) corrected ≥ 70%mmHg or DLCO corrected 60-69%mmHg and partial pressure of oxygen (pO2) ≥ 70mmHg.\n* Creatinine clearance \\> 60 mL\u002Fmin.\n* Prior autologous HCT is permissible if relapse occurred \\> 6 months after HCT.\n* Prior TBI-containing allogeneic HCT up to 3 Gy is permissible if \\> 6 months after HCT.\n* A human leukocyte antigen (HLA)-matched sibling\u002Funrelated donor, mismatched unrelated donor or haploidentical donor for collection of stimulated peripheral blood stem cells must be identified and readily available.\n* Ability to understand and sign a written informed consent document (or legal representative).\n* SIBLING DONOR: Related to the patient and genotypically or phenotypically identical for HLA-A, B, C, DRB1 and DQB1. Phenotypic identity must be confirmed by high-resolution typing.\n* MATCHED UNRELATED DONOR: Matched for HLA-A, B, C, DRB1 and DQB1 by high resolution typing; OR mismatched for a single allele without antigen mismatching at HLA-A, B, or C as defined by high resolution typing but otherwise matched for HLA-A, B, C, DRB1 and DQB1 by high resolution typing.\n* MATCHED UNRELATED DONOR: Donors are excluded when preexisting immunoreactivity is identified that would jeopardize donor hematopoietic cell engraftment. The recommended procedure for patients with 10 of 10 HLA allele level (phenotypic) match is to obtain panel reactive antibody (PRA) screens to class I and class II antigens for all patients before HCT. If the PRA shows \\> 10% activity, then flow cytometric or B and T cell cytotoxic cross matches should be obtained. The donor should be excluded if any of the cytotoxic cross match assays are positive. For those patients with an HLA Class I allele mismatch, flow cytometric or B and T cell cytotoxic cross matches should be obtained regardless of the PRA results. A positive anti-donor cytotoxic crossmatch is an absolute donor exclusion.\n* MATCHED UNRELATED DONOR: Patient and donor pairs homozygous at a mismatched allele in the graft rejection vector are considered a two-allele mismatch, i.e., the patient is A\\*0101 and the donor is A\\*0102, and this type of mismatch is not allowed.\n* MISMATCHED UNRELATED DONOR: HLA-matching must be based on results of high resolution typing at HLA-A, -B, -C, -DRB1, and -DQ.\n* MISMATCHED UNRELATED DONOR: Mismatch for one HLA class I antigen with or without an additional mismatch for one HLA-class I allele but matched for HLA-DRB1 and HLA-DQ.\n* MISMATCHED UNRELATED DONOR: Mismatched for two HLA class I alleles but matched for HLA-DRB1 and HLA-DQ.\n* MISMATCHED UNRELATED DONOR: HLA class I HLA-A, -B, -C allele matched donors allowing for any one or two DRB1 and\u002For DQB1 antigen\u002Fallele mismatch.\n* MISMATCHED UNRELATED DONOR: If the patient is homozygous at the mismatch HLA class I locus or II locus, the donor must be heterozygous at that locus and one allele must match the patient (i.e., patient is homozygous A\\*01:01 and donor is heterozygous A\\*01:01, A\\*02:01). This mismatch will be considered a one-antigen mismatch for rejection only.\n* HAPLOIDENTICAL DONOR: Donors must be haploidentical relatives of the patients. Donor-recipient compatibility will be tested through HLA typing at high resolution for the HLA loci (-A, -B, -C, -DRB1, -DQB1). Donor and recipient should share at least 5\u002F10 HLA loci.\n* HAPLOIDENTICAL DONOR: Age ≥ 18 years.\n* HAPLOIDENTICAL DONOR: Weight ≥ 40 kg.\n* HAPLOIDENTICAL DONOR: Donor must meet the selection criteria as defined by the Foundation of the Accreditation of Cell Therapy (FACT) and will be screened per the American Association of Blood Banks (AABB) guidelines.\n* DONOR: In case of more available donors, selection criteria should include, in this order:\n\n  * For cytomegalovirus (CMV) seronegative recipients, a CMV seronegative donor\n  * Red Blood Cell compatibility\n\n    * Red blood cell (RBC) cross match compatible\n    * Minor ABO incompatibility\n    * Major ABO incompatibility\n* DONOR: Donors will undergo diagnostic evaluation (clinical, laboratory test and imaging) as indicated per institutional guidelines.\n\nExclusion Criteria:\n\n* Active central nervous system (CNS) disease.\n* Concomitant illness associated with a likely survival of \\\u003C 1 year.\n* Active systemic fungal, bacterial, viral, or other infection, unless disease is under treatment with antimicrobials and\u002For controlled or stable. Patients with fever thought to be likely secondary to myeloid malignancy are eligible.\n* Known hypersensitivity or contraindication to any study drug used in this trial.\n* Pregnancy or lactation.\n* Concurrent treatment with any other approved or investigational anti-leukemia agent.\n* HAPLOIDENTICAL DONOR: Since detection of anti-donor-specific antibodies (anti-DSA) is associated with higher graft rejection rate, patients will be screened for anti-DSA pre-transplant. Patient with DSA mean fluorescent intensity (MFI) \\\u003C 5000 after desensitization treatment, will be considered eligible to participate in the study.",true,{"count":5,"type":22},[54,105],"This phase I\u002FII trial studies the safety, side effects, and best dose of decitabine in combination with fludarabine, cytarabine, filgrastim, and idarubicin (FLAG-Ida) and total body irradiation (TBI) followed by a donor stem cell transplant in treating adult patients with cancers of blood-forming cells of the bone marrow (myeloid malignancies) that are at high risk of coming back after treatment (relapse). Cancers eligible for this trial are acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and chronic myelomonocytic leukemia (CMML). Decitabine is in a class of medications called hypomethylation agents. It works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow. The FLAG-Ida regimen consists of the following drugs: fludarabine, cytarabine, filgrastim, and idarubicin. These are chemotherapy drugs that work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Filgrastim is in a class of medications called colony-stimulating factors. It works by helping the body make more neutrophils, a type of white blood cell. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. TBI is radiation therapy to the entire body. Giving chemotherapy and TBI before a donor peripheral blood stem cell (PBSC) transplant helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. When the healthy stem cells from a donor are infused into a patient, they may help the patient's bone marrow make more healthy cells and platelets. Giving decitabine in combination with FLAG-Ida and TBI before donor PBSC transplant may work better than FLAG-Ida and TBI alone in treating adult patients with myeloid malignancies at high risk of relapse.",[28,448,116,29,442,453,114,58,84,479,480,115,83,357],"Refractory Acute Undifferentiated Leukemia","Refractory Chronic Myelomonocytic Leukemia","2026-05-13",{"date":460,"type":34},{"date":484,"type":34},"2025-09-23",{"date":486,"type":22},"2028-11-29",{"name":67,"class":68},{"id":489,"slug":490,"hasResults":12,"nctId":491,"briefTitle":492,"officialTitle":493,"acronym":4,"eligibilityCriteria":494,"healthyVolunteers":12,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":495,"targetDuration":4,"studyType":23,"phases":496,"briefSummary":497,"conditions":498,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":502,"lastUpdatePostDateStruct":503,"startDateStruct":505,"completionDateStruct":507,"leadSponsor":509,"locationsCount":511},"100533189","phase-1-sndx-5613-and-gilteritinib-for-the-treatment-of-relapsed-or-refractory-flt3-mutated-acute-myeloid-leukemia-and-concurrent-mll-rearrangement-or-npm1-mutation-100533189","NCT06222580","SNDX-5613 and Gilteritinib for the Treatment of Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia and Concurrent MLL-Rearrangement or NPM1 Mutation","Safety and Efficacy of Dual Menin and FLT3 Inhibition in Patients With Relapsed\u002FRefractory FLT3- Mutated Acute Myeloid Leukemia Containing a Concurrent MLL-Rearrangement or NPM1 Mutation: A Phase I (Ph I) Study of SNDX-5613 + Gilteritinib","Inclusion Criteria:\n\n* Signed informed consent must be obtained prior to participation in the study\n* Age ≥ 18 years at the date of signing the informed consent form (ICF)\n* Morphologically confirmed diagnosis of the following based on 2022 World Health Organization (WHO) classification:\n\n  * Relapsed or Refractory Acute Myeloid Leukemia with the following:\n\n    * Refractory disease classified as having received 2 cycles of intensive induction or 2 cycles of hypomethylating agent (HMA) + Venetoclax with persistent disease of ≥ 5% blasts in the bone marrow and\u002For reappearance of peripheral blasts\n  * FLT-3 mutated disease of the ITD or TKD subtype, AND\n  * NPM1 mutation, MLL gene rearrangement and any other mutation that has proven HOXA-MEIS1 overexpression (NUP98, UBTF-TD, MLL-PTD and any others that have supporting literature)\n* Patients must be receiving itraconazole, ketoconazole, posaconazole, or voriconazole (strong CYP3A4 inhibitors) for antifungal prophylaxis for at least 24 hours prior to enrollment and while on SNDX-5613 treatment. Patients must not be receiving any other strong CYP3A4 inhibitors\u002Finducers\n* Not suitable for immediate myeloablative\u002Fintensive chemotherapy based on investigator assessment of age, comorbidities, local guidelines, institutional practice (any or all of these)\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN)\n* Total bilirubin ≤ 1.5 × ULN (except in the setting of isolated Gilbert syndrome)\n* Estimated Glomerular Filtration Rate (eGFR) ≥ 60 mL\u002Fmin\u002F1.73m\\^2 (estimation based on Modification of Diet in Renal Disease (MDRD) formula, by local laboratory)\n* Adequate cardiac function defined as ejection fraction (EF) of ≥50% by echocardiogram or multigated acquisition (MUGA) scan\n* Patient can communicate with the investigator and has the ability to comply with the requirements of the study procedures\n* Participants of childbearing potential must agree to have a negative serum pregnancy test at screening and a negative serum or urine pregnancy test on the first day of study treatment\n* Participants capable of impregnating others who are having intercourse with people of childbearing potential must agree to abstain from intercourse or have their partner use 2 forms of contraception from the screening visit until 90 days after the last dose of study treatment. They must also refrain from sperm donation from the screening visit until 90 days following the last dose of study treatment\n* Must be able to swallow the study medications\n* Any prior treatment-related toxicities resolved to ≤ grade 1 prior to enrollment, with the exception of ≤ grade 2 neuropathy or alopecia\n* Patients are not currently receiving the following therapies or have discontinued therapy based on the time periods below:\n\n  * Radiation Therapy: At least 60 days from prior total body irradiation (TBI), craniospinal radiation and\u002For ≥ 50% radiation of the pelvis, or at least 14 days from local palliative radiation therapy (small port)\n  * Stem Cell Infusion: At least 60 days must have elapsed from hematopoietic stem cell transplant (HSCT) and at least 4 weeks must have elapsed from donor lymphocyte infusion (DLI)\n  * Immunotherapy: At least 42 days since prior immunotherapy, including tumor vaccines and checkpoint inhibitors, and at least 21 days since receipt of chimeric antigen receptor therapy or other modified T cell therapy\n  * Antileukemia Therapy\\*\\*\\*: At least 14 days, or 5 half-lives, whichever is shorter, since the completion of antileukemic therapy (for example, but not limited to, small molecule or cytotoxic\u002Fmyelosuppressive therapy), with the following exceptions:\n  * Wah-out can be shorter for patients with rapidly progressing disease as determined by the treating investigator\n  * Hydroxyurea for cytoreduction can be initiated without restriction related to timing of study entry. Hydroxyurea can be continued concomitantly with SNDX-5613, with medical monitor approval. Patients may continue to receive prophylactic intrathecal chemotherapy at any time at the treating physician's discretion\n  * Hematopoietic Growth Factors: At least 7 days since the completion of therapy with short-acting hematopoietic growth factors and 14 days with long-acting growth factors\n  * Biologics (e.g., monoclonal antibody therapy): At least 90 days, or 5 half-lives, whichever is shorter, since the completion of therapy with an antineoplastic biologic agent\n  * Steroids: At least 7 days since systemic glucocorticoid therapy, unless receiving physiologic dosing (equivalent to ≤10 mg prednisone daily for patients ≥ 18 years or ≤10 mg\u002Fm\\^2 \u002Fday for patients\n\n    * Prior treatment with gilteritinib is allowed\n\nExclusion Criteria:\n\n* Diagnosis of acute promyelocytic leukemia\n* Diagnosis of extra-medullary acute myeloid leukemia (AML) based on WHO 2022 classification or myeloid sarcoma\n* Suspected central nervous system (CNS) involvement. Patients with history of cerebrospinal fluid (CSF) involvement must either have documented CSF clearance prior to treatment initiation or be receiving active treatment for CNS involvement\n* Participants with prior malignancy, except:\n\n  * Participants with history of adequately treated malignancy for which no anticancer systemic therapy (namely chemotherapy, radiotherapy or surgery) is ongoing or required during the course of the study\n  * Participants who are receiving adjuvant therapy such as hormone therapy are eligible. However, participants who developed therapy related neoplasms are not eligible\n* Previous known allergy\u002Fsensitivity to components of gilteritinib or SNDX-5613. Prior treatment with gilteritinib is allowed and does not exclude a patient\n* Patient with known human immunodeficiency virus (HIV) or has active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV). HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. For patients with evidence of chronic HBV infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Individuals with a history of HCV infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Fridericia's corrected QT interval (QTcF) \\> 450 msec at time of screening\n* Clinically significant ventricular arrhythmia (e.g., ventricular tachycardia, ventricular fibrillation, or Torsades de pointes)\n* Uncontrolled intercurrent illness including, but not limited to, unstable angina pectoris, serious cardiac arrhythmia, myocardial infarction within 2 months prior to enrollment, New York Heart Association (NYHA) Class III or IV heart failure\n* Patients with uncontrolled infection will not be enrolled until infection is treated and under control per the principal investigator or their designee\n* Any psychiatric illness that prevents patient from informed consent process\n* Pregnant or breastfeeding at the time of enrollment\n* Patient has a malabsorption syndrome or other condition that precludes an enteral route of administration\n* Patient has history of a cardiovascular, endocrinologic, hepatic, immunologic metabolic, neurologic, psychiatric, pulmonary, renal disease, or any other condition that in the opinion of the investigator would adversely affect his\u002Fher participation in this study or interpretation of study results",{"count":157,"type":22},[54],"This phase I trial tests the safety, side effects, and best dose of SNDX-5613 and gilteritinib for treating patients with acute myeloid leukemia that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory) and has a mutation in the FLT3 gene along with either a mutation in the NMP1 gene or a type of mutation called a rearrangement in the MLL gene. SNDX-5613 is in a class of medications called menin inhibitors. It works by blocking the action of mutated MLL and NMP1 proteins that signal cancer cells to multiply. Gilteritinib is in a class of medications called tyrosine kinase inhibitors. It works by blocking the action of mutated FLT3 proteins that signal cancer cells to multiply. Giving SNDX-5613 with gilteritinib may be safe, tolerable and\u002For effective in treating patients with relapsed\u002Frefractory FLT3 mutated acute myeloid leukemia.",[499,500,501,29,84],"Acute Myeloid Leukemia With FLT3\u002FITD Mutation","Acute Myeloid Leukemia With KMT2A Rearrangement","Acute Myeloid Leukemia With NPM1 Mutation","2026-05-12",{"date":504,"type":34},"2026-05-14",{"date":506,"type":34},"2024-02-20",{"date":508,"type":22},"2027-02-28",{"name":510,"class":68},"Uma Borate",4,{"id":513,"slug":514,"hasResults":12,"nctId":515,"briefTitle":516,"officialTitle":517,"acronym":4,"eligibilityCriteria":518,"healthyVolunteers":12,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":519,"targetDuration":4,"studyType":23,"phases":521,"briefSummary":522,"conditions":523,"keywords":4,"overallStatus":530,"whyStopped":4,"lastUpdateSubmitDate":531,"lastUpdatePostDateStruct":532,"startDateStruct":533,"completionDateStruct":535,"leadSponsor":537,"locationsCount":69},"100639858","phase-2-total-marrow-and-lymphoid-irradiation-in-combination-with-fludarabine-and-melphalan-as-conditioning-for-allogeneic-peripheral-blood-stem-cell-hematopoietic-cell-transplant-in-older-patients-with-refractory-and-relapsed-acute-myeloid-leukemia-and-high-risk-myelodysplastic-syndrome-100639858","NCT07582172","Total Marrow and Lymphoid Irradiation in Combination With Fludarabine and Melphalan as Conditioning for Allogeneic Peripheral Blood Stem Cell Hematopoietic Cell Transplant in Older Patients With Refractory and Relapsed Acute Myeloid Leukemia and High-risk Myelodysplastic Syndrome","Phase 2 Trial of Total Marrow and Lymphoid Irradiation (TMLI) as Conditioning for Allogeneic Peripheral Blood Stem Cell Hematopoietic Cell Transplantation (PBSC-HCT) From a Match Donor With Fludarabine and Melphalan in Older Patients With Refractory Acute Myeloid Leukemia and MDS","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative\n\n  * Assent, when appropriate, will be obtained per institutional guidelines\n* Agreement to allow the use of archival tissue from diagnostic tumor biopsies\n\n  * If unavailable, exceptions may be granted with study principal investigator (PI) approval\n* Age: ≥ 50 years (no upper age limit)\n\n  * Note: Patients ≥ 18 years and \\\u003C 50 years are also included if they are not candidates for myeloablative conditioning regimens due to comorbidities or active disease\n* Karnofsky or Lansky performance status ≥ 70\n* Eligible patients will have a histopathological confirmed diagnosis of hematologic malignancy in one of the following categories:\n\n  * Acute myeloid leukemia (AML):\n\n    * Patients with de novo or secondary disease in unfavorable risk group including poor risk cytogenetics according to National Comprehensive Cancer Network (NCCN) guidelines for AML i.e., monosomal karyotype, -5,5q-,-7,7q-,11q23-non t(9;11), inv (3), t(3;3), t(6;9), t(9;22) and complex karyotypes (≥ 3 unrelated abnormalities), or all patient in intermediate risk groups\n    * Patients with active disease:\n\n      * Morphologically\n      * Minimal residual disease (MRD) testing (MRD+ through flow cytometry, cytogenetics, or molecular assays)\n  * Myelodysplastic syndrome\u002Fchronic myelomonocytic leukemia (CMML) (MDS) with ≥ 10% blast\n* Patients must have an human leukocyte antigen (HLA) (A, B, C, and DRB1) identical sibling or a 8\u002F8 (A, B, C, and DR) allele matched unrelated donor who is willing to donate primed blood stem cells\n* Serum direct bilirubin ≤ 2.0 x upper limit of normal (ULN) (unless has Gilbert's disease) (within 35 days prior to day 1 of protocol therapy unless otherwise stated)\n* Aspartate aminotransferase (AST) ≤ 2.5 x ULN (within 35 days prior to day 1 of protocol therapy unless otherwise stated)\n* Alanine aminotransferase (ALT) ≤ 2.5 x ULN (within 35 days prior to day 1 of protocol therapy unless otherwise stated)\n* Creatinine clearance of ≥ 60 mL\u002Fmin per 24 hour urine test or the Cockcroft-Gault formula (within 35 days prior to day 1 of protocol therapy unless otherwise stated)\n* Left ventricular ejection fraction (LVEF) ≥ 50%\n\n  * Note: To be performed within 35 days prior to day 1 of protocol therapy\n* If able to perform pulmonary function tests: Forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC) and DLCO (diffusion capacity) ≥ 50% of predicted (corrected for hemoglobin)\n\n  * Note: To be performed within 35 days prior to day 1 of protocol therapy\n* If unable to perform pulmonary function tests: Oxygen (O2) saturation \\> 92% on room air\n\n  * Note: To be performed within 35 days prior to day 1 of protocol therapy\n* Seronegative for HIV antigen (Ag)\u002Fantibody (Ab) combo, hepatitis C virus (HCV), active hepatitis B virus (HBV) (surface antigen negative) (within 35 days prior to day 1 of protocol therapy unless otherwise stated)\n\n  * If seropositive for HIV, HCV or HBV, nucleic acid quantitation must be performed. Viral load must be undetectable\n  * HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* Meets institutional and federal requirements for infectious disease titer requirements\n\n  * Note: Infectious disease testing to be performed within 28 days prior to day 1 of protocol therapy\n* Women of childbearing potential (WOCBP): Negative urine or serum pregnancy test (within 35 days prior to day 1 of protocol therapy unless otherwise stated)\n\n  * If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 6 months after the last dose of protocol therapy\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only)\n\nExclusion Criteria:\n\n* Allogeneic stem cell transplant or autologous HCT within 1 year prior to day 1 of protocol therapy\n* Chemotherapy, radiation therapy, biological therapy, immunotherapy within 14 days of day 1 of protocol therapy\n\n  * Note: Low dose chemotherapy or maintenance chemotherapy given within 7 days of planned study enrollment is permitted. These include hydroxyurea, 6-meraptopurine, oral methotrexate, vincristine, oral etoposide, and tyrosine kinase inhibitors (TKIs). TKIs can also be given up to 3-5 days before conditioning regimen\n* More than three previous lines of intensive chemotherapy, where the regimen intent was to induce remission\n* Co-enrollment in other clinical trials involving post-HCT maintenance interventions or any study with potential to affect disease-free survival is not allowed\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent\n* Clinically significant uncontrolled illness\n* Active infection not responding to antibiotics\n* Other active malignancy. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Females only: Pregnant or breastfeeding\n* Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)",{"count":520,"type":22},35,[105],"This phase II trial tests the effect of total marrow and lymphoid irradiation (TMLI) in combination with fludarabine and melphalan as conditioning regimen in older patients with acute myeloid leukemia or high-risk myelodysplastic syndrome that has not responded to previous treatment (refractory) and that has come back after a period of improvement (relapsed) and are undergoing a donor (allogeneic) peripheral blood stem cell (PBSC) hematopoietic cell transplant (HCT) from a matched related or unrelated donor. HCT is the only curative treatment for high-risk patients, but the side effects related to the current conditioning treatments limit the use to younger and more fit patients. TMLI is a targeted form of total body radiation that uses intensity-modulated radiation therapy to target marrow, lymph node chains, and the spleen. It is designed to reduce radiation-associated side effects and maximize the radiation therapeutic effect. Fludarabine blocks cells from making deoxyribonucleic acid (DNA) and may kill cancer cells. It is a type of purine antagonist and a type of ribonucleotide reductase inhibitor. Melphalan is in a class of medications called alkylating agents. It may kill cancer cells by damaging their DNA and stopping them from dividing. Giving chemotherapy, such as fludarabine and melphalan, and TMLI before an allogeneic transplant helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells to grow. When healthy stem cells from a related or unrelated donor, such as PBSC HCT, that closely match the patient's blood, are infused into a patient, they may help the patient's bone marrow make more healthy cells and platelets, an may help destroy any remaining cancer cells. Giving TMLI in combination with fludarabine and melphalan as conditioning treatment for an allogeneic PBSC HCT from a matched related or unrelated donor may be safe, tolerable, and\u002For effective in treating high-risk older patients with relapsed and refractory acute myeloid leukemia or high-risk myelodysplastic syndrome.",[524,525,57,29,526,58,527,84,528,83,529],"Acute Myeloid Leukemia With Complex Karyotype","Myelodysplastic Chronic Myelomonocytic Leukemia","Recurrent Myelodysplastic Chronic Myelomonocytic Leukemia","Recurrent Secondary Acute Myeloid Leukemia","Refractory Myelodysplastic Chronic Myelomonocytic Leukemia","Refractory Secondary Acute Myeloid Leukemia","NOT_YET_RECRUITING","2026-05-06",{"date":502,"type":34},{"date":534,"type":22},"2027-04-05",{"date":536,"type":22},"2029-04-05",{"name":193,"class":68},{"id":539,"slug":540,"hasResults":12,"nctId":541,"briefTitle":542,"officialTitle":543,"acronym":4,"eligibilityCriteria":544,"healthyVolunteers":12,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":545,"targetDuration":4,"studyType":23,"phases":547,"briefSummary":548,"conditions":549,"keywords":4,"overallStatus":530,"whyStopped":4,"lastUpdateSubmitDate":531,"lastUpdatePostDateStruct":550,"startDateStruct":551,"completionDateStruct":553,"leadSponsor":555,"locationsCount":69},"100637206","phase-1-bsb-2002-after-cyclophosphamide-and-fludarabine-for-the-treatment-of-relapsed-or-refractory-acute-myeloid-leukemia-patients-with-npm1-mutation-100637206","NCT07583303","BSB-2002 After Cyclophosphamide and Fludarabine for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia Patients With NPM1 Mutation","A Phase 1 Dose Finding Study to Evaluate the Safety of BSB-2002 in Relapsed or Refractory Acute Myeloid Leukemia (AML) Patients With NPM1 Mutation","Inclusion Criteria:\n\n* Documented informed consent of the participant\n\n  * Note: For research participants who do not speak English, a short form consent may be used with a City of Hope (COH) certified interpreter\u002Ftranslator to proceed with screening, while the request for a translated full consent is processed\n* Age: ≥ 18 years\n* HLA-A\\*02:01\n* Eastern Cooperative Oncology Group (ECOG) ≤ 2\n* Adequate venous access for apheresis or agree to use of a central line for apheresis collection\n* AML diagnosed per ELN criteria which has been treated with at least two lines of therapy, and meet one of these 3 criteria:\n\n  * Which is relapsed (after previously complete remission, CR, CRh or CRi), OR\n  * Are refractory (failed to achieve complete remission) to the last treatment\n\n    * Primary refractory patients should have received at least two cycles of induction treatment, OR\n  * MRD positive (at least 1% leukemic blasts in blood or bone marrow) after being MRD negative following the last treatment\n* Positive for NPM1 mutation type A, D, G or H. The confirmation for NPM1 mutation must be performed by NGS within 3 months from enrollment\n* If participant has had prior hematopoietic cell transplant (HCT), all 3 of the following must be met:\n\n  * More than 3 months from transplant at the time of enrollment\n  * No clinically significant graft-versus (vs)-host disease requiring systemic treatment\n  * Any non-hematological toxicity related to transplant has resolved to \\\u003C grade 2 per Common Terminology Criteria for Adverse Events (CTCAE)\n* Total bilirubin ≤ 2 X upper limit of normal (ULN) (unless has Gilbert's disease or related to leukemia involving the liver) (performed within 6 weeks prior to leukapheresis unless otherwise stated)\n* Aspartate aminotransferase (AST) ≤ 3.0 x ULN (unless related to leukemia involving the liver) (performed within 6 weeks prior to leukapheresis unless otherwise stated)\n* Alanine aminotransferase (ALT) ≤ 3.0 x ULN (unless related to leukemia involving the liver) (performed within 6 weeks prior to leukapheresis unless otherwise stated)\n* Creatinine clearance of ≥ 40 mL\u002Fmin per 24 hour urine test or the Cockcroft-Gault formula, or serum creatinine ≤ 1.6mg\u002FdL and the participant is not on hemodialysis (performed within 6 weeks prior to leukapheresis unless otherwise stated)\n* No history of congestive heart failure class III or IV New York Heart Association (NYHA) OR left ventricular ejection fraction (LVEF) ≥ 45% up to 90 days before enrollment\n* If able to perform pulmonary function tests: Forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC) and diffusion capacity of the lung for carbon monoxide (DLCO) (diffusion capacity) ≥ 50% of predicted (corrected for hemoglobin)\n\n  * Note To be performed up to 90 days before enrollment\n* If unable to perform pulmonary function tests: Oxygen (O2) saturation \\> 92% on room air\n\n  * Note To be performed up to 90 days before enrollment\n* Seronegative for HIV antigen (Ag)\u002Fantibody (Ab) combo and no active hepatitis C virus (HCV) and hepatitis B virus (HBV) (surface antigen negative) (performed within 6 weeks prior to leukapheresis unless otherwise stated)\n\n  * If seropositive for HIV, HCV or HBV, nucleic acid quantitation must be performed. Viral load must be undetectable\n* Meets other institutional and federal requirements for infectious disease titer requirements\n\n  * Note Infectious disease testing to be performed within 28 days prior to leukapheresis\n* Women of childbearing potential (WOCBP): Negative urine or serum pregnancy test (performed within 6 weeks prior to leukapheresis unless otherwise stated)\n\n  * If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 12 months from the date of BSB-2002 infusion\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only)\n* CRITERIA TO PROCEED WITH LEUKAPHERESIS: Research participant has signed the informed consent\n* CRITERIA TO PROCEED WITH LEUKAPHERESIS: Research participant must have appropriate venous access, have a central line or be willing to undergo central or temporary line placement\n* CRITERIA TO PROCEED WITH LEUKAPHERESIS: Biochemistry laboratory results have been reviewed for clinical significance and appropriate measures taken. Hematology assessments are expected to be out of the normal range and do not need to be assessed for clinical significance\n* CRITERIA TO PROCEED WITH LEUKAPHERESIS: The last dose of systemic chemotherapy must be at least 2 weeks or 5 half-lives, whichever is shorter, before the leukapheresis procedure with the following exceptions:\n\n  * Steroids and vincristine are allowed up to 7 days prior to leukapheresis\n  * Intrathecal chemotherapy is allowed up to 3 days prior to leukapheresis\n  * Hydroxyurea is allowed up to 48 hours prior to leukapheresis\n  * The research participant cannot be on prednisone or equivalent doses of other corticosteroids at the time of leukapheresis. Note: Topical and inhaled corticosteroids in standard doses and physiologic replacement for subjects with adrenal insufficiency are allowed\n* CRITERIA TO PROCEED WITH LEUKAPHERESIS: The last dose of prior targeted agents, immunotherapy or radiation must be at least 2 weeks or 5 half-lives, whichever is shorter, before the leukapheresis procedure\n* CRITERIA TO PROCEED WITH LEUKAPHERESIS: If the research participant has undergone prior HCT, at least 3 months must have elapsed since receiving transplant to undergo peripheral blood mononuclear cell (PBMC) collection for BSB-2002 manufacturing\n* CRITERIA TO PROCEED WITH LYMPHODEPLETION: Research participant's BSB-2002 product is received by COH\n* CRITERIA TO PROCEED WITH LYMPHODEPLETION: Biochemistry laboratory results have been reviewed for clinical significance and appropriate measures taken. Hematology assessments are expected to be out of the normal range and do not need to be assessed for clinical significance\n* CRITERIA TO PROCEED WITH LYMPHODEPLETION: Research participant with no active CNS leukemia\n* CRITERIA TO PROCEED WITH LYMPHODEPLETION: Research participant must meet the following washout criteria:\n\n  * Regimen: Hydroxyurea; Required washout period: Stopped prior to start of lymphodepletion\n* CRITERIA TO PROCEED WITH LYMPHODEPLETION: ECOG ≤ 2\n* CRITERIA TO PROCEED WITH LYMPHODEPLETION: Women of childbearing potential (WOCBP): negative urine or serum pregnancy test within 30 days prior to the start of lymphodepletion. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* CRITERIA TO PROCEED WITH LYMPHODEPLETION: Research participants of reproductive potential must agree to use and utilize an adequate method of contraception throughout treatment and for at least 12 months after BSB-2002 T cell infusion\n* CRITERIA TO PROCEED WITH LYMPHODEPLETION: Not requiring supplemental oxygen or mechanical ventilation, oxygen saturation 92% or higher on room air\n* CRITERIA TO PROCEED WITH LYMPHODEPLETION: Not requiring pressor support, no symptomatic cardiac arrhythmias, no acute coronary syndrome, or uncontrolled hypertension\n* CRITERIA TO PROCEED WITH LYMPHODEPLETION: Calculated creatinine clearance (absolute value) of ≥ 40 mL\u002Fminute\n* CRITERIA TO PROCEED WITH LYMPHODEPLETION: Total bilirubin ≤ 2 times the institutional upper limit of normal (ULN)\n\n  * Note: In the event a participant has elevated levels of liver enzymes possibly related to underlying disease\u002Fdisease progression, the participant will still be considered eligible\n* CRITERIA TO PROCEED WITH LYMPHODEPLETION: ALT ≤ 3 times the institutional ULN\n\n  * Note: In the event a participant has elevated levels of liver enzymes possibly related to underlying disease\u002Fdisease progression, the participant will still be considered eligible\n* CRITERIA TO PROCEED WITH LYMPHODEPLETION: AST ≤ 3 times the institutional ULN\n\n  * Note: In the event a participant has elevated levels of liver enzymes possibly related to underlying disease\u002Fdisease progression, the participant will still be considered eligible\n* CRITERIA TO PROCEED WITH LYMPHODEPLETION: No new neurological deficits\n* CRITERIA TO PROCEED WITH LYMPHODEPLETION: No clinical evidence of uncontrolled active infectious process\n* CRITERIA TO PROCEED WITH LYMPHODEPLETION: Participants must be cytomegalovirus (CMV) negative (by polymerase chain reaction \\[PCR\\])\n* CRITERIA TO PROCEED WITH BSB-2002 INFUSION: Biochemistry laboratory results have been reviewed for clinical significance and appropriate measures taken. Hematology assessments are expected to be out of the normal range and do not need to be assessed for clinical significance\n* CRITERIA TO PROCEED WITH BSB-2002 INFUSION: Prohibited medications have not been administered\n* CRITERIA TO PROCEED WITH BSB-2002 INFUSION: ECOG ≤ 2\n* CRITERIA TO PROCEED WITH BSB-2002 INFUSION: Absolute lymphocyte count (ALC) \\\u003C 500\u002FµL (0.5 × 10\\^⁹\u002FL)\n\n  * Discuss with sponsor if ALC target is not achieved by day -1\n* CRITERIA TO PROCEED WITH BSB-2002 INFUSION: Patient must not have any medical condition that render the patient unstable, including but not limited to untreated infection, altered mental status, unstable vital signs, worsening cardiovascular status, requiring discussion with the sponsor\n\nExclusion Criteria:\n\n* Leukemic blast count of \\> 20,000\u002Fµl. If the blast count can be maintained below the threshold with hydroxyurea, the patient would be eligible\n* Extramedullary only AML\n* Central nervous system (CNS) involvement refractory to intrathecal chemotherapy and\u002For standard cranial- spinal radiation\n* Candidates for hematopoietic cell transplant\n* Eligible to receive an approved targeted therapy\n* Treatment with other investigational agents within 5 half-lives of the planned dosing of BSB-2002 (day 0)\n* Ongoing treatment with chronic immunosuppressants (e.g., cyclosporine or systemic steroids at any dose)\n* Unstable cardiac disease as defined by one of the following:\n\n  * Cardiac events such as myocardial infarction (MI) within the past 6 months\n  * NYHA (New York Heart Association) heart failure class III-IV\n  * Uncontrolled atrial fibrillation or hypertension\n* Uncontrolled bacterial, viral, or fungal infections at time of enrollment\n* Other active malignancy that requires treatment. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Females only: Pregnant or breastfeeding\n* Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures or interference with study participation or data interpretation\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)",{"count":546,"type":22},19,[54],"This phase I trial studies the side effects and best dose of BSB-2002 when given after cyclophosphamide and fludarabine and tests how well it works in treating NPM1-mutated acute myeloid leukemia (AML) that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). BSB-2002 is a type of personalized autologous T cell receptor-modified T cell therapy. T cells are infection fighting blood cells that can kill cancer cells. The T cells given in this study come from the patient and have a new gene put in them that makes them able to recognize mutated NPM1, a protein on the surface of cancer cells. These NPM1 mutated-specific T cells may help the body's immune system identify and kill NPM1-mutated AML cells. Giving chemotherapy, such as cyclophosphamide and fludarabine, before BSB-2002 helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. Giving BSB-2002 after cyclophosphamide and fludarabine may be safe, tolerable, and\u002For effective in treating relapsed or refractory AML in patients with NPM1 mutation.",[29,84],{"date":481,"type":34},{"date":552,"type":22},"2026-12-14",{"date":554,"type":22},"2027-04-16",{"name":193,"class":68},{"id":557,"slug":558,"hasResults":12,"nctId":559,"briefTitle":560,"officialTitle":561,"acronym":4,"eligibilityCriteria":562,"healthyVolunteers":12,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":563,"targetDuration":4,"studyType":23,"phases":565,"briefSummary":566,"conditions":567,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":570,"lastUpdatePostDateStruct":571,"startDateStruct":573,"completionDateStruct":575,"leadSponsor":577,"locationsCount":69},"100373289","phase-1-azacitidine-venetoclax-and-gilteritinib-in-treating-patients-with-recurrentrefractory-flt3-mutated-acute-myeloid-leukemia-chronic-myelomonocytic-leukemia-or-high-risk-myelodysplastic-syndromemyeloproliferative-neoplasm-100373289","NCT04140487","Azacitidine, Venetoclax, and Gilteritinib in Treating Patients With Recurrent\u002FRefractory FLT3-Mutated Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia, or High-Risk Myelodysplastic Syndrome\u002FMyeloproliferative Neoplasm","A Phase I\u002FII Study of Azacitidine, Venetoclax, and Gilteritinib for Patients With Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome With an Activating FLT3 Mutation","Inclusion Criteria:\n\n* Diagnosis:\n\n  * Phase I cohort: Adults ≥ 18 years with relapsed\u002Frefractory FLT3-mutated AML or CMML or other MDS\u002FMPN that is intermediate-2 or high-risk by the International Prognostic Scoring System\n  * Phase II cohort A: Adults ≥ 18 years with newly diagnosed FLT3-mutated AML\n  * Phase II cohort B: Adults ≥ 18 years with relapsed\u002Frefractory FLT3-mutated AML or CMML or other MDS\u002FMPN that is intermediate-2 or high-risk by the International Prognostic Scoring System\n  * For all cohorts, patients with either FLT3-internal tandem duplication (FLT3-ITD) or FLT3 D835 mutations will be eligible\n* Performance status ≤ 3 (Eastern Cooperative Oncology Group \\[ECOG\\] scale)\n* Total serum bilirubin ≤ 2.5 x upper limit of normal (ULN), unless due to Gilbert's syndrome, hemolysis or the underlying leukemia approved by the principal investigator (PI)\n* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 3 x ULN, unless due to the underlying leukemia approved by the PI\n* Creatinine clearance ≥ 30 mL\u002Fmin\n* Ability to swallow\n* Signed informed consent\n\nExclusion Criteria:\n\n* Prior therapies:\n\n  * Phase I cohort: No restriction based on prior therapies\n  * Phase II cohort A: Patients with prior therapy for AML are not eligible. Prior therapy for antecedent hematologic disorder is allowed. Prior hydroxyurea or cytarabine given for purposes of cytoreduction is also allowed. Prior all trans-retinoic acid given for presumed acute promyelocytic leukemia is also allowed\n  * Phase II cohort B: No restriction on number of prior therapies\n* Patients suitable for and willing to receive intensive induction chemotherapy (for Phase II cohort A only)\n* Congenital long QT syndrome or corrected QT interval by Fridericia (QTcF) \\> 450 msec. Repeat electrocardiograms (EKGs) after correction of electrolytes or discontinuation of QT prolonging medications are allowed to meet entry criteria. In cases where QTcF \\> 450 msec is considered to be falsely increased due to inaccurate automated reading and not clinically significant (e.g. due to bundle branch block), patients are still eligible if cardiologist reviews and documents that QTcF is ≤ 450 msec when manually measured\n* Active serious infection not controlled by oral or intravenous antibiotics (e.g. persistent fever or lack of improvement despite antimicrobial treatment)\n* Active grade III-V cardiac failure as defined by the New York Heart Association criteria\n* Active central nervous system leukemia\n* Known human immunodeficiency virus (HIV) seropositive\n* Known hepatitis B surface antigen seropositive or known or suspected active hepatitis C infection\n\n  * Note: Patients who have isolated positive hepatitis B core antibody (i.e., in the setting of negative hepatitis B surface antigen and negative hepatitis B surface antibody) must have an undetectable hepatitis B viral load. Patients who have positive hepatitis C antibody may be included if they have an undetectable hepatitis C viral load\n* Patients with a prior or concurrent malignancy whose natural history or treatment is not anticipated to interfere with the safety or efficacy assessment of the investigational regimen may be included only after discussion with the PI\n* Consumed strong inducer of cytochrome P450, family 3, subfamily A (CYP3A) or p-glycoprotein within 3 days of study enrollment. Agents include but are not limited to: carbamazepine, phenytoin, rifampin, and St. John's wort\n* Treatment with any investigational antileukemic agents or chemotherapy agents in the last 7 days before study entry, unless full recovery from side effects has occurred or patient has rapidly progressive disease judged to be life-threatening by the investigator. Prior recent treatment with corticosteroids, hydroxyurea and\u002For cytarabine (given for cytoreduction) permitted\n* Pregnant women will not be eligible; women of childbearing potential should have a negative pregnancy test prior to entering on the study and be willing to practice methods of contraception throughout the study period and for at least 6 months after the last dose of study drugs. Women do not have childbearing potential if they have had a hysterectomy or are postmenopausal without menses for 12 months. In addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential and should practice an effective method of birth control throughout the study period and for at least 4 months after the last dose of study drugs. Lactating women (or those planning to breastfeed) should not breastfeed during treatment of gilteritinib and for at least 2 months after the last dose of gilteritinib",{"count":564,"type":22},97,[54,105],"This phase I\u002FII trial studies the side effects and best dose of gilteritinib and to see how well it works in combination with azacitidine and venetoclax in treating patients with FLT3-mutation positive acute myeloid leukemia, chronic myelomonocytic leukemia, or high-risk myelodysplastic syndrome\u002Fmyeloproliferative neoplasm that has come back (recurrent) or has not responded to treatment (refractory). Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Gilteritinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving azacitidine, venetoclax, and gilteritinib may work better compared to azacitidine and venetoclax alone in treating patients with acute myeloid leukemia, chronic myelomonocytic leukemia, or myelodysplastic syndrome\u002Fmyeloproliferative neoplasm.",[29,453,568,84,480,569],"Recurrent Myelodysplastic\u002FMyeloproliferative Neoplasm","Refractory Myelodysplastic\u002FMyeloproliferative Neoplasm","2026-04-13",{"date":572,"type":34},"2026-04-16",{"date":574,"type":34},"2019-12-17",{"date":576,"type":22},"2028-09-01",{"name":254,"class":68},{"id":579,"slug":580,"hasResults":12,"nctId":581,"briefTitle":582,"officialTitle":583,"acronym":4,"eligibilityCriteria":584,"healthyVolunteers":12,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":585,"targetDuration":4,"studyType":23,"phases":587,"briefSummary":588,"conditions":589,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":590,"lastUpdatePostDateStruct":591,"startDateStruct":593,"completionDateStruct":595,"leadSponsor":597,"locationsCount":69},"100239243","phase-1-onc201-in-treating-patients-with-relapsed-or-refractory-acute-leukemia-or-high-risk-myelodysplastic-syndrome-100239243","NCT02392572","ONC201 in Treating Patients With Relapsed or Refractory Acute Leukemia or High-Risk Myelodysplastic Syndrome","Phase I\u002FII Study of Oral ONC201 in Patients With Relapsed or Refractory Acute Leukemias and High-Risk Myelodysplastic Syndromes","Inclusion Criteria:\n\n* For Arms A, B, C, D, E, F patients must have relapsed or refractory acute leukemias or high-risk MDS for which no standard therapies are anticipated to result in a durable remission\n* Age \\>= 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n* Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use acceptable contraceptive methods (abstinence, intrauterine device \\[IUD\\], oral contraceptive or double barrier device, such as a condom, diaphragm, or cervical\u002Fvault cap), for 16 weeks after the last dose of study drug, and must have a negative serum or urine pregnancy test within 1 week prior to beginning treatment on this trial; nursing patients are excluded; sexually active men must also use acceptable contraceptive methods for the duration of time on study and for at least 16 weeks after the last dose of study drug; pregnant and nursing patients are excluded because the effects of ONC201on a fetus or nursing child are unknown\n* Must be able and willing to give written informed consent\n* The interval from prior treatment to time of study drug administration should be at least 2 weeks for cytotoxic agents or at least 5 half-lives for noncytotoxic agents; if the patient is on hydroxyurea to control peripheral blood leukemic cell counts, the patient must be off hydroxyurea for at least 24 hours before initiation of treatment on this protocol; persistent clinically significant toxicities from prior therapy must not be greater than grade 1\n* Serum creatinine \\\u003C 2.0 mg\u002Fdl\n* Total bilirubin =\\\u003C 1.5 x the upper limit of normal (ULN) unless considered due to Gilbert's syndrome\n* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) =\\\u003C 3 x the ULN unless considered due to organ leukemic involvement\n* Relapse \\> 6 months since autologous or allogeneic stem cell transplantation provided:\n\n  * No active graft-versus-host disease (GVHD \\> grade 1)\n  * No treatment with high dose steroids for GVHD (up to \\>= 20 mg prednisolone or equivalent per day)\n  * No treatment with immunosuppressive drugs with the exception of low dose cyclosporine and tacrolimus\n\nExclusion Criteria:\n\n* Uncontrolled intercurrent illness including, but not limited to uncontrolled infection, symptomatic congestive heart failure (New York Heart Association class III and IV), uncontrolled cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Active heart disease including myocardial infarction within previous 3 months, symptomatic coronary artery disease, arrhythmias not controlled by medication, or uncontrolled congestive heart failure (New York Heart Association class III and IV)\n* Patients receiving any other standard or investigational treatment for their hematologic malignancy within past 2 weeks for cytotoxic agents or at least 5 half-lives for noncytotoxic agents\n* Subject has been diagnosed or treated for another malignancy within 3 years of enrolment, except in situ malignancy, or low-risk prostate, skin or cervix cancer after curative therapy\n* Known history of seropositive for human immunodeficiency virus (HIV) antibodies (HIV1 and HIV2), hepatitis C antibody (Hep C Ab) or a hepatitis B carrier (positive for hepatitis B surface antigen \\[HBsAg\\])\n* Active drug use or alcoholism\n* Known or active central nervous system (CNS) involvement by leukemia\n* White blood cell count more than 25 x 109\u002FL prior to initiation of venetoclax",{"count":586,"type":22},120,[54,105],"This phase I\u002FII trial studies the side effects and best dose of ONC201 and to see how well it works in treating patients with acute leukemia or high-risk myelodysplastic syndrome that has returned after a period of improvement (relapsed) or does not respond to treatment (refractory). ONC201 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.",[113,29,58,112,84,83],"2026-04-10",{"date":592,"type":34},"2026-04-14",{"date":594,"type":34},"2015-11-03",{"date":596,"type":22},"2026-11-30",{"name":254,"class":68}]