[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"leukemia-myeloid-acute\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:leukemia-myeloid-acute":27},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,26,0,25,[9,66,90,111,133,158,188,221,245,267,297,324,352,375,400,421,456,478,500,525,550,581,608,633,657],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":65},"100609581","phase-2-trial-of-orca-t-following-reduced-intensity-or-nonmyeloablative-conditioning-in-patients-with-acute-myeloid-leukemia-or-myelodysplastic-syndrome-100609581",false,"NCT07216443","Trial of Orca-T Following Reduced Intensity or Nonmyeloablative Conditioning in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome","A Phase 2 Trial of Orca-T Following Reduced Intensity or Nonmyeloablative Conditioning in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome","Inclusion Criteria:\n\n1. Age ≥18 years at the time of enrollment\n2. Diagnosed with 1 of the following diseases:\n\n   1. Acute myeloid, or mixed phenotype leukemia in complete remission (CR) or CR with incomplete hematologic recovery (CRi), with or without the presence of known minimal residual disease.\n   2. Myelodysplastic syndrome that is indicated for alloHCT per the 2017 International Expert Panel recommendations and\u002For therapy-related\u002Fsecondary MDS as defined by the World Health Organization (WHO) classification of myeloid malignancies, with ≤10% blast burden in the bone marrow.\n3. Planned to undergo 1 of the following preparative regimens as per Investigator discretion:\n\n   1. RIC cohort: Planned RIC-alloHCT including RIC regimen with TBI\u002Fthiotepa\u002Ffludarabine\n   2. NMA cohort: Planned NMA-alloHCT including NMA regimen with fludarabine\u002Fcyclophosphamide\u002FTBI\n4. Identified related or unrelated donor who is an 8\u002F8 match for HLA-A, -B, -C, and -DRB1\n5. Estimated glomerular filtration rate ≥30 mL\u002Fminute\n6. Cardiac ejection fraction at rest ≥40% or shortening fraction of ≥22% by echocardiogram or radionuclide scan (MUGA)\n7. Diffusing capacity of the lung for carbon monoxide (adjusted for hemoglobin) ≥40%\n8. Negative serum or urine β-HCG test in persons of childbearing potential\n9. Alanine transaminase (ALT)\u002Faspartate transaminase (AST) \\\u003C5 times the upper limit of normal (ULN)\n10. Total bilirubin \\\u003C3 × ULN\n11. Deemed ineligible for a fully myeloablative alloHCT per assessment of the principal investigator\n\nExclusion Criteria:\n\n1. Prior alloHCT\n2. Currently receiving corticosteroids or other immunosuppressive therapy. Topical corticosteroids or oral systemic corticosteroid doses less than or equal to 10 mg\u002Fday are allowed.\n3. Planned donor lymphocyte infusion (DLI)\n4. Planned pharmaceutical in vivo or ex vivo T-cell depletion\n5. Recipient-positive antidonor HLA antibodies against a mismatched allele in the selected donor\n6. Karnofsky performance score \\\u003C60%\n7. For RIC cohort only: HCT-Specific Comorbidity Index (HCT-CI) ≥6\n8. Uncontrolled bacterial, viral, or fungal infection (currently taking antimicrobial therapy and with progression or no clinical improvement) at the time of enrollment\n9. Seropositive for HIV-1 or -2, HTLV-1 or -2, hepatitis B surface antigen, or HCV antibody unless previously treated with curative therapy and are HCV NAT negative\n10. Known allergy or hypersensitivity to or intolerance of tacrolimus\n11. Documented allergy or hypersensitivity to iron dextran or bovine, murine, algal, or Streptomyces avidinii proteins\n12. Any uncontrolled autoimmune disease requiring active immunosuppressive treatment\n13. Concurrent malignancy within 1 year except nonmelanoma skin cancer that has been curatively resected\n14. Psychosocial circumstances that preclude the participant being able to go through transplantation or participate responsibly in follow-up care\n15. Persons who are pregnant or breastfeeding\n16. Person of childbearing potential (POCBP) or men who have sexual contact with POCBP who are unwilling to use effective forms of birth control or abstinence for 1 year after transplantation.\n17. Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's or medical monitor's judgment, precludes the recipient's safe participation in and completion of the trial or which could affect compliance with the protocol or interpretation of results","ALL","18 Years",{"count":20,"type":21},80,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This study will evaluate the safety, tolerability, and efficacy of Orca-T in participants undergoing reduced intensity or non-myeloablative allogeneic hematopoietic cell transplantation (alloHCT) for hematologic malignancies. Orca-T is an allogeneic stem cell and T-cell immunotherapy biologic manufactured for each patient (transplant recipient) from the mobilized peripheral blood of a specific, unique donor. It is composed of purified hematopoietic stem and progenitor cells (HSPCs), purified regulatory T cells (Tregs), and conventional T cells (Tcons).",[27,28,29],"Leukemia, Myeloid, Acute","Myelodysplastic Syndromes","Mixed Phenotype Acute Leukemia",[27,28,29,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52],"Therapy-Related Myelodysplastic Syndrome","Hematopoietic Stem Cell Transplantation","Humans","Graft vs Host Disease","SERENE-T","ORCA-T","Disease","Pathologic Processes","Neoplasms by Histologic Type","Neoplasms","Hematologic Diseases","Bone Marrow Diseases","Precancerous Conditions","Neoplasms by Site","Disease Attributes","Immunoproliferative Disorders","Immune System Diseases","Leukemia","Preleukemia","Hematologic Neoplasms","Syndrome","Acute Disease","RECRUITING","2026-06-18",{"date":56,"type":57},"2026-06-23","ACTUAL",{"date":59,"type":57},"2025-12-09",{"date":61,"type":21},"2028-12",{"name":63,"class":64},"Orca Biosystems, Inc.","INDUSTRY",5,{"id":67,"slug":68,"hasResults":12,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":22,"phases":76,"briefSummary":78,"conditions":79,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":89},"100581585","phase-3-a-study-of-bleximenib-venetoclax-and-azacitidine-for-treatment-of-participants-with-newly-diagnosed-acute-myeloid-leukemia-aml-100581585","NCT06852222","A Study of Bleximenib, Venetoclax and Azacitidine For Treatment of Participants With Newly Diagnosed Acute Myeloid Leukemia (AML)","A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Study of Bleximenib, Venetoclax and Azacitidine for the Treatment of Participants With Newly Diagnosed Acute Myeloid Leukemia Harboring KMT2A Rearrangements or NPM1 Mutations Who Are Ineligible for Intensive Chemotherapy","cAMeLot-2","Inclusion criteria:\n\n* Be 18 years of age or older at the time of informed consent\n* Previously untreated lysine N-methyltransferase 2A gene rearranged (KMT2Ar) or nucleophosmin 1 gene mutated (NPM1m) acute myeloid leukemia (AML) with greater than or equal to (\\> or =) 10% bone marrow blasts per 2022 international Consensus Classification criteria\n* Ineligible for intensive chemotherapy based on the following criteria: a) \\>= 75 years of age and ineligible per physician's discretion, with Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, b) \\>=18 to \\\u003C75 years of age with \\>= 1 of the following comorbidities: i) ECOG performance status of 2, ii) Severe cardiac disorder, iii) Severe pulmonary disorder, iv) Renal impairment, v) Moderate hepatic impairment vi) Comorbidity that, in the investigator's opinion, makes the participant unsuitable for intensive chemotherapy, which must be documented before enrollment as defined in the protocol. Ineligibility for intensive chemotherapy should be explicitly approved by a multidisciplinary team in countries in which this process is standard of care\n* Participants must have adequate hepatic and renal function\n* A female participant must agree not to be pregnant, breast-feed, plan to become pregnant and use protocol-specified contraception while enrolled in this study and for 6 months after the last dose of study treatment\n* A male participant must agree to use protocol-specified contraception while enrolled in this study for at least 90 days after the last dose of study treatment\n* Must sign an informed consent form indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study\n\nExclusion criteria:\n\n* Diagnosis of acute promyelocytic leukemia (APL)\n* Known active leukemic involvement of the central nervous system (CNS)\n* Recipient of solid organ transplant\n* Any cardiac disorders such as heart attack, uncontrolled\u002Funstable chest pain, congestive heart failure, uncontrolled or symptomatic irregular heartbeat, blockage of a blood vessel to brain, or transient ischemic (decreased oxygen in tissue) attack within 6 months of randomization\n* Active infectious hepatitis\n* Live, attenuated vaccine within 4 weeks of randomization\n* Known allergies, hypersensitivity, or intolerance of bleximenib, azacitidine, or venetoclax excipients",{"count":75,"type":21},600,[77],"PHASE3","The purpose of this study is to assess how bleximenib and Venetoclax (VEN)+ Azacitidine (AZA) works as compared to placebo and VEN+AZA alone for the treatment of participants with newly diagnosed Acute Myeloid Leukemia (AML) with a mutation in the NPM1 or KMT2A gene.",[27],"2026-06-04",{"date":82,"type":57},"2026-06-05",{"date":84,"type":57},"2025-06-04",{"date":86,"type":21},"2029-08-15",{"name":88,"class":64},"Janssen Research & Development, LLC",250,{"id":91,"slug":92,"hasResults":12,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":4,"eligibilityCriteria":96,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":97,"targetDuration":4,"studyType":22,"phases":99,"briefSummary":101,"conditions":102,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":104,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},"100566134","phase-1-a-study-of-jnj-90189892-for-relapsed-or-refractory-acute-myeloid-leukemia-or-myelodysplastic-neoplasms-100566134","NCT06651229","A Study of JNJ-90189892 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms","A Phase 1, First-in-Human, Dose Escalation Study of JNJ-90189892 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms","Inclusion Criteria:\n\n* A. For Parts 1, 2, and 3: Have a diagnosis, per the world health organization (WHO) 2022 criteria, of (a) Parts 1, 2, and 3: Acute myeloid leukemia (AML) or (b) Parts 1 and 2: Moderate high, high, or very high-risk myelodysplastic neoplasms (MDS) per Molecular International Prognostic Scoring System (IPSS-M); B. For Part 4 only: Previously untreated acute myeloid leukemia (AML) per the WHO 2022 criteria\n* Body weight that is greater than or equals to (\\>=) 40 kg\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2\n* Have adequate renal function defined as Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Estimated Glomerular Filtration Rate (eGFR) \\>=40 milligrams per minute (mL\u002Fmin) computed with the calculator on the national kidney foundation website\n* Participants must have laboratory parameters in the required range\n\nExclusion Criteria:\n\n* Has a medical history of clinically significant pulmonary compromise, particularly the current need for supplemental oxygen use to maintain adequate oxygenation\n* Has evidence of uncontrolled systemic viral, bacterial, or fungal infection. Antimicrobial prophylaxis is permitted\n* All participants- Has known allergies, hypersensitivity, or intolerance to JNJ-90189892 or its excipients; Parts 3 and 4- Has known allergies, hypersensitivity, or intolerance to venetoclax (VEN), azacitadine (AZA), or their excipients\n* Had major surgery or had significant traumatic injury within 14 days of planned first dose of JNJ-90189892\n* Had a prior or concurrent second malignancy with natural history or treatment likely to interfere with any study endpoints of safety or the efficacy of the study treatment\n* Has known active central nervous system involvement",{"count":98,"type":21},155,[100],"PHASE1","The purpose of Part 1 (Dose Escalation) of the study is to assess the effective dose (recommended Phase 2 dose\\[s\\] \\[RP2Ds\\]) that can be safely administered, and dosing regimens of JNJ-90189892 in participants with relapsed or refractory (R\u002FR) acute myeloid leukemia (AML) or R\u002FR higher-risk type of myelodysplastic neoplasms (MDS \\[type of cancer of the blood and bone marrow, which does not respond to treatment or comes back after treatment\\]). The purpose of Part 2 (Cohort Expansion) is to further assess the safety, tolerability and efficacy in participants with R\u002FR AML or higher-risk types of MDS at the RP2D regimen(s). The purpose of Part 3 and 4 is to assess the effective dose (recommended Phase 2 combination dose \\[RP2CD\\]) that can be safely administered, and dosing regimens of JNJ-90189892 in combination with azacitadine (AZA) + venetoclax (VEN) in participants with R\u002FR AML (part 3) and newly diagnosed (ND) AML (part 4).",[27,103],"Myelodysplastic Neoplasms",{"date":82,"type":57},{"date":106,"type":57},"2025-03-21",{"date":108,"type":21},"2028-11-21",{"name":88,"class":64},9,{"id":112,"slug":113,"hasResults":12,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":4,"eligibilityCriteria":117,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":118,"targetDuration":4,"studyType":22,"phases":120,"briefSummary":121,"conditions":122,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":132},"100548695","phase-1-mb-dnpm1-tcr1-in-relapsedrefractory-aml-100548695","NCT06424340","MB-dNPM1-TCR.1 in Relapsed\u002FRefractory AML","A Phase I\u002FII Trial of MB-dNPM1-TCR.1 in HLA-A*02:01-positive Patients With Relapsed or Refractory NPM1-mutated AML to Determine Safety and Obtain First Data on Efficacy","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Patients must be able to understand and be willing to give signed informed consent\n3. Relapsed or refractory acute myeloid leukemia (last disease staging within 4 weeks prior to screening) without standard treatment options defined as:\n\n   * No morphological CR or extramedullary AML after at least two courses of intensive chemotherapy, decitabine or other standard therapy or\n   * MRD positive after at least two courses of intensive chemotherapy or other standard therapy and not eligible for allogeneic stem cell transplantation or\n   * Relapsed bone marrow or blood disease or extramedullary AML after CR after first line treatment and not eligible to undergo allogeneic stem cell transplantation or\n   * Bone marrow, blood, extramedullary AML relapse or non-response or MRD positivity after allogeneic stem cell transplantation and not eligible to receive Donor Lymphocyte Infusion (DLI) according to local standards, relapse or MRD positive after DLI.\n4. Positive for HLA-A\\*02:01 according to genotyping results.\n5. AML has NPM1 mutation which is recognized by dNPM1-TCR.1 and for which a specific Q-PCR is available for disease monitoring.\n6. Number of circulating WBC above 1x109\u002FL with less than 50% leukemic blasts and 0.03 x 109 CD8+ T cells\u002FL.\n7. Life expectancy of at least 3 months.\n8. ECOG performance status 0-3.\n9. Negative pregnancy test in women of childbearing potential.\n10. For fertile men and women, agreement to use highly effective contraceptive methods during the trial.\n\nExclusion Criteria:\n\n1. Pregnant or breast feeding women.\n2. Active infection with HIV-1, HIV-2, HBV, HCV, HTLV-I, HTLV-II, SARS-CoV-2 or Treponema Pallidum.\n3. Any clinically significant, advanced or unstable disease or inadequate main organ function that may put the patient at increased risk for severe complications of trial participation at the discretion of the investigator.\n4. Use of systemic immune suppression including, but not limited to:\n\n   immunosuppressive agents such as cyclosporine or corticosteroids (at an equivalent dose of 0.5 mg prednisone\u002Fkg body weight per day, or higher). Inhaled steroid and physiological replacement for adrenal insufficiency are allowed.\n5. Unwillingness or inability to comply with procedures required in this clinical trial protocol.\n6. Uncontrolled life-threatening infections or uncontrolled disseminated intravascular coagulation; however, if these problems resolve, the start of treatment can be initiated on a delayed schedule.\n7. Subjects currently on any other IMP (including within the last 30 days before start of treatment).\n8. Current use of high dose immunosuppression for immune disorders interfering with T cell function (on discretion of the investigator).\n9. Known hypersensitivity against any drug of the mandatory trial procedures.\n10. Serum creatinine ≥ 2.0 × ULN or eGFR \\\u003C 30 mL\u002Fmin calculated according to the modified MDRD formula.\n11. BMI ≥40\n12. Has received vaccination with live vaccines 6 weeks prior to treatment\n13. Major surgery less than 30 days before start of treatment.\n14. Committal to an institution on judicial or official order.",{"count":119,"type":21},29,[100,24],"The goal of this Phase I\u002FII, single arm, prospective, open label, dose escalation trial is to assess safety, feasibility and efficacy of ex vivo expanded autologous T cells genetically modified to express a T cell receptor (TCR) specific for dNPM1 peptides restricted to human leukocyte antigen (HLA) A\\*02:01 in patients with relapsed or refractory AML.",[27],"2026-04-13",{"date":125,"type":57},"2026-04-16",{"date":127,"type":57},"2024-08-01",{"date":129,"type":21},"2028-06",{"name":131,"class":64},"Miltenyi Biomedicine GmbH",1,{"id":134,"slug":135,"hasResults":12,"nctId":136,"briefTitle":137,"officialTitle":137,"acronym":4,"eligibilityCriteria":138,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":139,"targetDuration":4,"studyType":22,"phases":141,"briefSummary":143,"conditions":144,"keywords":4,"overallStatus":148,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":132},"100629049","ehealth-mindfulness-based-music-therapy-intervention-for-patients-undergoing-stem-cell-transplantation-100629049","NCT07469592","eHealth Mindfulness-based Music Therapy Intervention for Patients Undergoing Stem Cell Transplantation","Inclusion Criteria:\n\n* ≥ 18 years of age\n* have a primary diagnosis of a hematologic malignancy (e.g., myelodysplastic syndrome \\[MDS\\], acute myeloid leukemia \\[AML\\], acute lymphoblastic leukemia \\[ALL\\], or non Hodgkin's Lymphoma \\[NHL\\])\n* have a treatment plan for a hematopoietic stem cell transplant\n* Speak English or Spanish\n\nExclusion Criteria:\n\n* history of severe psychiatric illness (e.g., psychosis, active suicidality, inpatient treatment in the past 12 months)\n* severe cognitive impairment (per the short portable mental status questionnaire)\n* hearing impairment\n* active alcohol or substance dependence within the past six months\n* participated in the prior pilot MBMT R61 phase\n* participated in music therapy or mindfulness programs in the past six months",{"count":140,"type":21},165,[142],"NA","The goal of this study is to test an electronic health (eHealth) mindfulness-based music therapy intervention to improve health-related quality of life and reduce symptom burden and disease activity in patients undergoing stem cell transplantation.",[145,28,27,146,147],"Stem Cell Transplantation","Precursor Cell Lymphoblastic Leukemia-Lymphoma","Lymphoma, Non-Hodgkin","NOT_YET_RECRUITING","2026-04-10",{"date":123,"type":57},{"date":152,"type":21},"2026-06-30",{"date":154,"type":21},"2028-06-30",{"name":156,"class":157},"University of Miami","OTHER",{"id":159,"slug":160,"hasResults":12,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":4,"eligibilityCriteria":164,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":165,"targetDuration":4,"studyType":22,"phases":167,"briefSummary":168,"conditions":169,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":179,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":187},"100516228","phase-1-safety-and-tolerability-of-ziftomenib-combinations-in-patients-with-relapsedrefractory-acute-myeloid-leukemia-100516228","NCT06001788","Safety and Tolerability of Ziftomenib Combinations in Patients With Relapsed\u002FRefractory Acute Myeloid Leukemia","Phase 1 Study to Determine the Safety and Tolerability of Ziftomenib Combinations for the Treatment of KMT2A-rearranged or NPM1-mutant Relapsed\u002FRefractory Acute Myeloid Leukemia","Key Inclusion Criteria:\n\n* Has been diagnosed with relapsed\u002Frefractory AML.\n* Has a documented NPM1 mutation or KMT2A rearrangement.\n* Has a documented FLT3 mutation (cA-3 only).\n* Has an Eastern Cooperative Oncology Group (ECOG) Performance status ≤ 2.\n* Has adequate hepatic and renal function as defined per protocol.\n* Has an ejection fraction above a protocol defined limit.\n* Participant, or legally authorized representative, must be able to understand and provide written informed consent prior to the first screening procedure.\n* Has agreed to use contraception as defined per protocol.\n\nKey Exclusion Criteria:\n\n* Has a diagnosis of acute promyelocytic leukemia or blast chronic myeloid leukemia.\n* Has clinically active central nervous system leukemia.\n* Has an active and uncontrolled infection.\n* Has a mean corrected QT interval (QTcF) \\> 480ms.\n* Has uncontrolled intercurrent illness, including, but not limited to protocol defined cardiac disease.\n* Has received radiation, chemotherapy, immunotherapy, or any other anticancer therapy including investigational therapy \\\u003C14 days or within 5 drug half-lives prior to the first dose of study intervention.\n* Has had major surgery within 4 weeks prior to the first dose of study intervention.\n* Has received a hematopoietic stem cell transplant (HSCT) and has not previously had adequate recovery per protocol defined criteria.\n* Has active graft-versus-host disease (GvHD) and or on immunosuppressive drugs for the treatment of GvHD\n* Participant is pregnant or lactating.",{"count":166,"type":21},171,[100],"The safety, tolerability, and antileukemic response of ziftomenib in combination with standard of care treatments for patients with relapsed\u002Frefractory acute myeloid leukemia will be examined with the following agents: FLAG-IDA, low-dose cytarabine, and gilteritinib.",[170,171,172,173,174,175,48,176,177,27,178,39],"AML","AML With Mutated NPM1","Hematologic Malignancy","KMT2Ar","NPM1 Mutation","MLL Rearrangement","Acute Myeloid Leukemia","Leukemia, Myeloid","Acute Leukemia",{"date":180,"type":57},"2026-04-14",{"date":182,"type":57},"2024-02-22",{"date":184,"type":21},"2027-08",{"name":186,"class":64},"Kura Oncology, Inc.",45,{"id":189,"slug":190,"hasResults":12,"nctId":191,"briefTitle":192,"officialTitle":193,"acronym":4,"eligibilityCriteria":194,"healthyVolunteers":12,"sex":17,"minAge":195,"maxAge":4,"enrollmentInfo":196,"targetDuration":4,"studyType":22,"phases":198,"briefSummary":199,"conditions":200,"keywords":203,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":220},"100438382","phase-1-a-phase-12-study-of-enzomenib-dsp-5336-in-patients-with-acute-leukemia-horizen-1-100438382","NCT04988555","A Phase 1\u002F2 Study of Enzomenib (DSP-5336) in Patients With Acute Leukemia (Horizen-1)","A Phase 1\u002F2, Open-Label, Dose-Escalation, Dose-Expansion Study of Enzomenib (DSP-5336) in Patients With Acute Leukemia and Other Selected Hematologic Malignancies, With and Without Mixed Lineage Leukemia (MLL) Rearrangement or Nucleophosmin 1 (NPM1) Mutation (Horizen-1)","Inclusion Criteria:\n\nFor patients in Phase I:\n\n1. Have a diagnosis of relapsed or refractory AML, ALL or acute leukemia of ambiguous lineage according to World Health Organization (WHO) 2022 classification, or, in selected sites and regions, a diagnosis of MDS or MM as determined by pathology review at the treating institution, and whose disease has progressed after available standard therapies known to be active for their AML, ALL, or acute leukemia of ambiguous lineage or, in selected sites and regions, for MM or MDS. If acute leukemia patients are transformation from MDS or other hematologic malignancies, patients need to receive available standard therapies as acute leukemia after AML transformation and before enrolling this trial. In regions or countries where required by regulatory authorities, participants must have a documented KMT2A (MLL) fusion or NPM1 mutation, including those with coexisting FLT3 genomic alterations and\u002For IDH1\u002F2 mutation. Participants who are candidates for stem cell transplantation must have been offered this therapeutic option.\n\n   For patients with MDS (selected sites and regions):\n   1. Patients with MDS must have bone marrow blasts ≥ 5%\n   2. Patients with MDS must have relapsed or refractory disease and have exhausted available standard therapies including at least 2 cycles of treatment with HMA\n\n      For patients with MM (selected sites and regions):\n   3. Have a confirmed diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) 2016 classification (Kumar, 2016) and whose disease has progressed after treatment with a minimum of 3 prior anti-myeloma regimens including a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 monoclonal antibody (mAb); patients must not be candidates for available therapies with established clinical benefit\n   4. Have measurable disease as defined in the protocol\n   5. Meet the laboratory parameters set in the protocol\n\n      For patients with relapsed\u002Frefractory AML in the venetoclax and azacitidine combination cohort (in countries and sites where permitted):\n   6. Have MLLr or NPM1m.\n\n      For patients with relapsed\u002Frefractory AML in the gilteritinib combination cohort (in countries and sites where permitted):\n   7. Have MLLr or NPM1m AND any of the following FLT3 mutations: FLT3-ITD, FLT3-TKD\u002FD835 or FLT3-TKD\u002FI836.\n\n      For patients with relapsed\u002Frefractory AML with NPM1 enrolled in the RP2D confirmation cohort:\n   8. Must have ≥5% blasts in bone marrow by morphologic assessment\n   9. Must not have received prior treatment with a menin inhibitor\n\n      For patients with newly diagnosed AML:\n   10. Must have AML as defined by WHO 2022 criteria with a documented MLLr or NPM1m (patients with AML characterized by MLL partial tandem duplications, MLL deletions, or trisomy 11 are not eligible)\n   11. Must not have received treatment for AML with the exception of hydroxyurea for control of white blood cell counts.\n\n   For patients in Phase 2:\n2. Have a confirmed diagnosis of relapsed AML or ALL according to WHO 2022 classification, as determined by pathology review at the treating institution, and who have ≥5% blasts by morphologic assessment in the bone marrow. Patients with extramedullary disease or peripheral blasts as the only manifestation of relapse are not eligible. Patients must have received clinically applicable standard therapies with confirmed survival benefit. Patients must not have had prior exposure to a menin inhibitor.\n3. Have a documented KMT2A (MLL)-fusion assessed at relapse or immediately prior to the determination of refractory status. KMT2A genetic alterations other than fusions (eg, KMT2A-PTD, amplification, point mutation) are not permitted.\n\n   For all patients:\n4. Be \\> 18 years of age. For countries and sites where approved, for DSP-5336 monotherapy, acute leukemia patients ≥12 years of age who weigh ≥40 kg may be enrolled.\n5. Have an Eastern Cooperative Oncology Group (ECOG) performance status ≤2.\n6. For monotherapy, WBC below 30,000\u002Fμ at enrollment. For the combination arms, WBC count must be below 25,000\u002FuL at enrollment and prior to starting treatment. (Hydroxyurea and steroids for cytoreduction purposes are allowed prior to enrollment and during study treatment)\n7. Clearance of creatinine level ≥ 50 ml\u002Fmin, assessed by the CPK-EPI formula (2021 version and Cystatin C not required)\n8. Total bilirubin ≤1.5 the upper limit of normal (ULN) (or ≤2.0 ULN for patients with known Gilbert's syndrome)\n9. Aspartate aminotransferase (AST) ≤3.0 times ULN\n10. Alanine aminotransferase (ALT) ≤3.0 times ULN\n11. Any prior treatment-related toxicities resolved to Grade ≤1 prior to enrollment, with the exception of Grade ≤2 alopecia or neuropathy\n12. Be willing to attend study visits as required by the protocol\n13. Have an estimated life expectancy ≥3 months, based on the investigator's assessment\n14. Females of childbearing potential must have a negative serum pregnancy test. Females of childbearing potential are defined as women who have (1) experienced menarche and have not undergone sterilization procedures (hysterectomy, or bilateral oophorectomy), or have (2) not experienced menopause as defined in the protocol.\n15. All men and all women of childbearing potential and male patients' partners who are women of childbearing potential are required to use a highly effective method of contraception during the study and for 6 months (for females and males alike) after the last dose of study drug. Further guidelines noted in protocol.\n16. Have AML\u002FALL\u002FMDS\u002FMM bone marrow material suitable for genomic analysis of AML,ALL, MDS, or MM genetic alterations. Note: If a bone marrow material is insufficient, an alternative suitable tissue (ex: peripheral blood) must be provided.\n\nExclusion Criteria:\n\n1. Has a left ventricular ejection fraction (LVEF) \\\u003C50%, as determined by ECHO\n2. Histological diagnosis of acute promyelocytic leukemia\n3. Received systemic calcineurin inhibitors within 2 weeks prior to the first dose of DSP 5336\n4. Have abnormal ECGs at screening that are clinically significant, such as (QTc \\>480 msec, with QTc corrected according to Fridericia's formula (QTcF). For clinical sites in the UK, have abnormal ECGs at screening that are clinically significant, such as QTc ≥470 msec and ≥450 msec with QTc corrected according to Fridericia's formula (QTcF), for females and males, respectively. In addition, patients with a history of prolonged QT syndrome or who are required to take therapies associated with QT-interval prolongation are excluded.\n\n   Note: In case of bundle branch block, QT interval correction can be performed.\n5. Has an active and uncontrolled, bacterial, viral, or fungal infection requiring parenteral therapy. Note: Patients must be afebrile with negative blood cultures at least 72 hours prior to Cycle 1 Day 1.\n6. Receives concurrent sensitive substrates with a narrow safety window or strong inhibitors or inducers of CYP3A4\u002F5, including specifically: ketoconazole, isavuconazole and itraconazole. Other antifungals that are used as standard of care to prevent or treat infections are permitted. If a patient is on one of the excluded azole class antifungals, he\u002Fshe can be taken off or switched to a permitted azole 7 or more days prior to first dose, then the patient could be allowed on study (Arm B) with approval of the medical monitor.\n7. Had major surgery within 28 days prior to the first dose of DSP-5336\n8. Has active central nervous system leukemia (prophylactic intrathecal chemotherapy is allowed).\n9. Underwent HSCT or chimeric antigen receptor cell (CAR-T) therapy or other modified T-cell therapy within 60 days prior to the first dose of DSP-5336. For clinical sites in the UK, underwent CAR-T therapy or other modified T-cell therapy within 6 months prior to the first dose of DSP-5336.\n10. Received a donor lymphocyte infusion within 28 days prior to the first dose of DSP-5336, or receiving immunosuppressive therapy post-HSCT at the time of screening, or with clinically active GVHD or GVHD requiring active medical intervention other than the use of topical steroids for ongoing cutaneous GVHD\n11. Received antineoplastic agents (except hormonal therapies as adjuvant maintenance for breast or prostate cancers if a patient is taking before starting study treatment, and hydroxyurea given for controlling blast cells) or other investigational treatment within 7 days or 5 half-lives, whichever is shortest, prior to the first dose of DSP-5336\n12. In the opinion of the treating investigator, have any concurrent conditions that could pose an undue medical hazard or interfere with interpretation of study results; these conditions include, but are not limited to: clinically significant non-healing or healing wounds; concurrent congestive heart failure (New York Heart Association Functional Classification Class III or IV; see Section 21.2); concurrent unstable angina; concurrent cardiac arrhythmia requiring treatment (excluding asymptomatic atrial fibrillation); recent (within the prior 6 months) myocardial infarction; acute coronary syndrome within the previous 6 months; significant pulmonary disease (shortness of breath at rest or on mild exertion), eg, due to concurrent severe obstructive pulmonary disease, concurrent hypertension not controlled with concomitant medication, or diabetes mellitus with more than 2 episodes of ketoacidosis in the prior 6 months\n13. Have a known detectable viral load for human immunodeficiency virus or hepatitis C, or evidence of hepatitis B surface antigen, all being indicative of active infection.\n\n    For sites in Japan, Taiwan, and Korea only: Hepatitis B core (HBc) antibody or hepatitis B surface (HBs) antibody test should be performed if HBsAg is negative. If HBc antibody or HBs antibody test is positive, HBV DNA quantification test should be performed to confirm that HBV DNA is negative.\n14. Have severe dysphagia, short-gut syndrome, gastroparesis, or other conditions that limit the ingestion or gastrointestinal absorption of drugs administered orally, including the inability to swallow oral medication\n15. Have cognitive, psychological, or psychosocial impediment that would impair the ability of the patient to receive therapy according to the protocol, or adversely affect the ability of the patient to comply with the informed consent process, protocol, or protocol-required visits and procedures\n16. Are pregnant or breastfeeding or planning to become pregnant. Note: Patients who are breastfeeding may be enrolled if they interrupt breastfeeding prior to the first dose of any study drugs and do not feed the baby with breast milk expressed after receiving the first dose of any study drugs. Breastfeeding should not be resumed for at least 6 months after the last dose of study drug\n17. Have any history or complication of interstitial lung disease (for sites in Japan in Phase 1 dose escalation).\n\n    For clinical sites in the EU, have a history of Grade ≥ 2 drug-induced interstitial lung disease or Grade ≥ 2 non-infectious pneumonitis within 6 months of starting study treatment.\n18. Have a history of Torsades de Pointes\n19. Received systemic calcineurin inhibitors within 4 weeks prior to the first dose of DSP-5336\n20. Have plasma cell leukemia (\\>2.0 x 109 \u002FL plasma cells in blood by standard differential) (for patients with MM)\n21. For patients intending to enroll into the combination cohort with gilteritinib: Patients must be gilteritinib-naïve or sensitive and have not received a FLT3 inhibitor in the relapsed refractory setting (prior FLT3 inhibitor in front line therapy is allowed)\n22. Have a known intolerance of hypersensitivity reaction to components of the investigational medicinal product\n23. For clinical sites in the UK: In Arm E (DSP-5336 + venetoclax\u002Fazacitidine), have received a live vaccine within 30 days prior to the first dose of DSP-5336","12 Years",{"count":197,"type":21},606,[100,24],"A phase 1\u002F2 dose escalation \u002F dose expansion study of Enzomenib (DSP-5336) in patients with acute leukemia.",[27,201,202,28],"Leukemia, Lymphocytic, Acute","Multiple Myeloma",[204,205,206,207,208,209,210],"Relapsed or refractory AML","MLLr","Menin","NPM1m","KMT2A","MDS","MM","2026-03-20",{"date":213,"type":57},"2026-03-24",{"date":215,"type":57},"2022-02-28",{"date":217,"type":21},"2027-12-31",{"name":219,"class":64},"Sumitomo Pharma America, Inc.",104,{"id":222,"slug":223,"hasResults":12,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":4,"eligibilityCriteria":227,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":228,"enrollmentInfo":229,"targetDuration":4,"studyType":22,"phases":231,"briefSummary":232,"conditions":233,"keywords":234,"overallStatus":148,"whyStopped":4,"lastUpdateSubmitDate":236,"lastUpdatePostDateStruct":237,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":243,"locationsCount":132},"100482674","phase-2-cd34-transplants-for-leukemia-and-lymphoma-100482674","NCT05565105","CD34+ Transplants for Leukemia and Lymphoma","A Phase II Trial of CD34+ Enriched Transplants From HLA-Compatible Related or Unrelated Donors for Treatment of Patients With Leukemia or Lymphoma","Inclusion Criteria:\n\n* Malignant conditions or other life-threatening disorders correctable by transplant for which CD34+ selected, T-cell depleted allogeneic hematopoietic stem cell transplantation is indicated such as:\n\n  1. AML in 1st remission - for patients who is AML does not have 'good risk' cytogenetic features (i.e. t8:21, t 15: 17, inv16).\n  2. Secondary AML in 1st remission\n  3. AML in 1st relapse or 2nd remission\n  4. ALL\u002FCLL in patient remission clinical or molecular features indicating a high risk for relapse; or ALL\u002FCLL 2nd remission\n  5. CML failing to respond to or not tolerating imatinib or dasatinib in first chronic phase of disease; CML in accelerated phase, second chronic phase, or in CR after accelerated phase or blast crisis.\n  6. Non-Hodgkin's lymphoma with chemo responsive disease in any of the following categories:\n\n     1. Intermediate or high-grade lymphomas who have failed to achieve a first CR or have relapsed following a 1st remission who are not candidates for autologous transplants.\n     2. Any NHL in remission which is considered not curable with chemotherapy alone and not eligible\u002Fappropriate for autologous transplant.\n  7. Chronic myelomonocyte leukemia: CMML-1 and CMML-2.\n\nThe following inclusion criteria are also required:\n\n* Patient's age includes from ≥18 to ≤74 years old.\n* Patients may be of either gender or any ethnic background.\n* Patients must have a Karnofsky (adult) Performance Status of at least 70%\n* Patients must have adequate organ function measured by:\n\nCardiac: asymptomatic or if symptomatic then LVEF at rest must be 50% and must improve with exercise.\n\nHepatic: \\\u003C 3x ULN AST and: s 1.5 total serum bilirubin, unless there is congenital benign hyperbilirubinemia or if the hyperbilirubinemia is directly caused by the disease in which the patient is receiving a transplant (e.g. AML Chloroma obstructing the biliary tree). Patients with higher bilirubin levels due to causes other than active liver disease is also eligible with Pl approval e.g. patients with PNH, Gilbert's disease or other hemolytic disorders.\n\nRenal: serum creatinine: s; 1.2 mg\u002FdL or if serum creatinine is outside the normal range, then CrCl \\> 30 ml\u002Fmin (measured or calculated\u002Festimated).\n\nPulmonary: asymptomatic or if symptomatic, DLCO 50% of predicted (corrected for hemoglobin).\n\nEach patient must be willing to participate as a research subject and must sign an informed consent form.\n\nExclusion Criteria:\n\n* Female patients who are pregnant or breast-feeding\n* Active viral, bacterial or fungal infection\n* Patient seropositive for HIV-I \u002FII; HTLV -I \u002FII\n* Presence of leukemia in the CNS","74 Years",{"count":230,"type":21},100,[24],"This study will evaluate whether processing blood stem cell transplants using an investigational device (the CliniMACS system) results in less complications for patients undergoing transplant for treatment of a blood malignancy (cancer) or blood disorder.",[27,201],[235],"Stem Cell Transplant","2026-03-02",{"date":238,"type":57},"2026-03-03",{"date":240,"type":21},"2026-06",{"date":242,"type":21},"2033-06",{"name":244,"class":157},"Guenther Koehne",{"id":246,"slug":247,"hasResults":12,"nctId":248,"briefTitle":249,"officialTitle":250,"acronym":4,"eligibilityCriteria":251,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":252,"targetDuration":4,"studyType":254,"phases":4,"briefSummary":255,"conditions":256,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":257,"lastUpdatePostDateStruct":258,"startDateStruct":260,"completionDateStruct":262,"leadSponsor":264,"locationsCount":266},"100560665","toxicity-genetic-determinants-and-response-to-azacitidine-and-venetoclax-in-aml-100560665","NCT06580106","Toxicity Genetic Determinants and Response to Azacitidine and Venetoclax in AML","A Prospective Pilot Study of the Genetic Determinants of Toxicity and Response to Azacitidine and Venetoclax in Patients With Newly Diagnosed Acute Myeloid Leukemia Through Evaluation of Polymorphisms in Pharmacokinetic Genes and Venetoclax Levels","Inclusion Criteria:\n\n* Written informed consent and HIPAA authorization for release of personal health information.\n* Age ≥ 18 years of age at the time of enrollment\n* Confirmed diagnosis of AML\n* Planned initial treatment with azacitidine and venetoclax\n* Ability to read and understand the English and\u002For Spanish language\n* As determined by the enrolling investigator, ability of the participant to understand and comply with study procedures for the entire length of the study\n\nExclusion Criteria:\n\n* None",{"count":253,"type":21},50,"OBSERVATIONAL","The purpose of this research is to see how certain genetic variations relate to side effects and outcomes experienced while receiving treatment with azacitidine and venetoclax.",[27],"2026-01-30",{"date":259,"type":57},"2026-02-02",{"date":261,"type":57},"2025-04-09",{"date":263,"type":21},"2030-01",{"name":265,"class":157},"Wake Forest University Health Sciences",2,{"id":268,"slug":269,"hasResults":12,"nctId":270,"briefTitle":271,"officialTitle":271,"acronym":272,"eligibilityCriteria":273,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":274,"enrollmentInfo":275,"targetDuration":4,"studyType":22,"phases":277,"briefSummary":278,"conditions":279,"keywords":282,"overallStatus":148,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":289,"startDateStruct":291,"completionDateStruct":293,"leadSponsor":295,"locationsCount":266},"100542604","phase-1-chimeric-antigen-receptor-treatment-targeting-cd70-seventy-100542604","NCT06345027","Chimeric Antigen Receptor Treatment Targeting CD70 (SEVENTY)","CASEY","Procurement Inclusion Criteria:\n\n1. Diagnosis of primary refractory or relapsed Acute Myeloid Leukemia (AML) with the exception of acute promyelocytic leukemia (APL). Patients with targetable mutations should have failed or be ineligible for targeted therapies (e.g. FLT3 inhibitors, IDH inhibitors or anti-CD33 drug conjugate)\n\n   OR\n\n   Patients with other relapsed or refractory CD70+ leukemia that would be considered an indication for allogeneic Hematopoietic Stem Cell Transplant (HSCT) if remission can be achieved. (CD19+ leukemia only: Patients must have failed or be ineligible to receive commercial CD19.CAR T cell treatments.)\n\n   Primary refractory or resistant disease, for purposes of procurement, defined as not achieving complete remission (CR) (i.e., a remaining blast count of 5% or more) after 1 to 2 cycles of intense induction therapy.\n\n   Relapse is defined as (1) hematologic relapse after complete remission based on bone marrow blasts \\>=5%, or reappearance of blasts in the blood, or development of extramedullary disease; (2) molecular relapse after minimal residual disease (MRD) negative, complete remission based on reoccurrence of MRD as assessed by RT-qPCR or by multi-parametric flow cytometry (MFC)\n2. CD70 positive leukemia with at least 26% CD70+ blasts by flow cytometry or immunohistochemistry (staining can be pending at time of procurement)\n3. Age ≤75 years. NOTE: The first three (3) patients treated on the study will be adults (≥18 years of age)\n4. Hemoglobin ≥ 7.0 g\u002FdL (can be transfused)\n5. If apheresis required to collect blood\n\n   * PT and aPTT \\\u003C1.5x ULN\n   * Serum Creatinine \\\u003C 2 x ULN\n   * AST \\\u003C 5 x ULN\n6. Informed consent\n\nProcurement Exclusion Criteria:\n\n1. Diagnosis of acute promyelocytic leukemia (APL)\n2. Active infection (bacterial, fungal, or viral) requiring ongoing treatment without improvement.\n3. Known active infection with HIV or HTLV (collected blood will be sent for HIV\u002FHTLV testing, separate testing prior to procurement not required). Patients with HIV are eligible if viral load is undetectable on therapy and CD4 count is \\>350 mm3.\n4. Active second cancer (except non-melanoma skin cancer or in situ breast cancer or cervical cancer) or other cancer treated ≤ 2 years prior to enrollment\n5. Ongoing treatment with immune suppression for prophylaxis\u002Ftreatment of GVHD including high dose steroids (e.g. prednisone equivalent \\> 0.5 mg\u002Fkg\u002Fday)\n\nTreatment Inclusion Criteria:\n\n1. Diagnosis of primary refractory or relapsed Acute Myeloid Leukemia (AML) with the exception of acute promyelocytic leukemia (APL) Patients with targetable mutations should have failed or be ineligible for targeted therapies (e.g. FLT3 inhibitors, IDH inhibitors, or anti-CD33 drug conjugate).\n\n   OR\n\n   Patients with other relapsed or refractory CD70+ hematological leukemias that would be considered an indication for allogeneic Hematopoietic Stem Cell Transplant (HSCT) if remission can be achieved. Patients with CD19+ malignancies must have failed or be ineligible to receive commercial CD19.CAR T cell treatments.\n\n   Primary refractory or resistant disease as defined by not achieving complete remission (CR) (i.e., a remaining blast count of 5% or more) after 1 to 2 cycles of intense induction therapy. Patients with no reduction in blast count after the first cycle or with p53 mutations without CR after the first cycle of intense induction therapy are also considered primary refractory.\n\n   Relapse is defined as (1) hematologic relapse after complete remission based on bone marrow blasts \\>=5%, or reappearance of blasts in the blood, or development of extramedullary disease; (2) molecular relapse after minimal residual disease (MRD) negative, complete remission based on reoccurrence of MRD as assessed by RT-qPCR or by multi-parametric flow cytometry (MFC)\n2. Confirmation from the patient's primary physician team of a suitable allogeneic hematopoietic stem cell transplant (HSCT) donor. OR Documentation that patient declines a potential subsequent HSCT)\n3. CD70 positive leukemia with at least 26% CD70+ cells by flow cytometry or immunohistochemistry (tissue)\n4. No systemic chemotherapy at least 2 weeks prior to treatment on study and must be recovered from all acute toxic effects of prior chemotherapy at time of treatment.\n5. Age ≤ 75 years. NOTE: The first three (3) patients treated on the study should be adults (≥18 years of age). Thereafter, a thorough review of the safety data will be performed and submitted to the FDA for approval prior to enrolling pediatric patients.\n6. Hemoglobin ≥ 7.0 g\u002FdL (can be transfused)\n7. Total bilirubin \\\u003C 3 times the upper limit of normal\n8. AST\u002FALT \\\u003C 5 times the upper limit of normal\n9. Estimated GFR ≥ 60ml\u002Fmin\n10. Pulse oximetry of \\> 90% on room air\n11. Karnofsky\u002FLansky score of ≥ 60%\n12. Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 6 months after the study is concluded. Male partner should use a condom\n13. Informed consent obtained\n\nTreatment Exclusion Criteria:\n\n1. Diagnosis of acute promyelocytic leukemia (APL)\n2. Currently receiving any investigational agents or received any tumor vaccines within the previous 6 weeks.\n3. Pregnant or lactating.\n4. Uncontrolled infection with HIV, or HTLV. Patients with HIV are eligible if viral load is undetectable on therapy and CD4 count is \\>350 mm3.\n5. Clinically significant bacterial, fungal, or viral infection requiring ongoing therapy without improvement.\n6. Cardiac abnormalities: Cardiac echocardiography with LVEF\\\u003C50%; Cardiac dysfunction NYHA III or IV; Clinically significant pericardial effusion. Confirmation of absence of these conditions within 6 months of treatment.\n7. Presence of CNS disease: Defined as detectable cerebrospinal blast cells in a sample of CSF with ≥ 5 WBCs per mm3 or known CNS tumors\u002Fchloromas (repeat spinal tap within 4 weeks only required for leukemia patients with known CNS disease)\n8. Use of serotherapy with Campath or Anti-Thymocyte Globulin (ATG) within the last 28 days\n9. Use of Donor Lymphocyte Infusion (DLI) or other cellular therapy product within 28 days\n10. Acute GVHD ≥ Grade 2 or moderate to severe (formerly extensive) chronic GVHD\n11. High dose steroids \\>1 mg\u002Fkg within preceding 5 days or currently receiving \\>0.5mg\u002Fkg\u002Fday prednisone equivalent\n12. Hyperleukocytosis (WBC ≥ 50K) or rapidly progressive disease that in the estimation of the investigator would compromise the ability of the patient to complete the initial 6 weeks of the study","75 Years",{"count":276,"type":21},12,[100],"This study is for patients who have a type of blood cancer that expresses the protein CD70, which includes acute myeloid leukemia (AML), T-cell leukemia or B-cell leukemia (and the leukemia has come back or has not gone away after standard of care treatment).\n\nAs there are limited or no remaining standard treatments available to treat this cancer, subjects are being asked to volunteer to be in a gene transfer research study using special immune cells to create a specialized immune cell that will recognize a protein called CD70 that is expressed on the outside surface of the leukemia cells in a subject's body.\n\nThe body has different ways of fighting infection and disease. No one way seems perfect for fighting cancers. This research study combines different ways of fighting disease by using T cells and \"arming\" them to recognize a specific protein on cancer cells. T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells including tumor cells. T cells by themselves have been used to treat patients with cancers and have shown promise, but have not been strong enough to cure most patients.\n\nT lymphocytes can kill tumor cells but there normally are not enough of them to kill all the tumor cells. Some researchers have taken T cells from a person's blood, grown more of them in the laboratory and then given them back to the person.\n\nThe protein used in this study is called anti-CD70. It has been developed from human CD27 on normal T cells, since it is the natural binding partner that can connect with CD70. This anti-CD70 protein sticks to leukemia cells when it binds to CD70. CD70 binders have been used to treat people with leukemia. For this study, anti-CD70 has been changed so that instead of floating free in the blood it is now joined to the T cells. When an antibody is joined to a T cell in this way it is called a chimeric receptor or \"CAR T cell\". The doctors then made another change to cause these T cells to kill any cell that has CD70. This causes the \"CAR T cells\" to kill blood cancer cells which are confirmed to have CD70.\n\nIn the laboratory, investigators have found that T cells work better if there are proteins added which stimulate T cells. The anti-CD70 (CD27) protein is unique because it can bind to CD70 on leukemia cells but also stimulates the T cells that express it. Adding the CD27 makes the cells grow better and may help them to last longer in the body, thus giving the cells a better chance of killing the leukemia cells.\n\nThese CD70 \"CAR\" T cells are investigational products not approved by the Food and Drug Administration.\n\nThe purpose of this study is to find a dose of CAR T cells that is safe, to learn what the side effects are and to see whether this therapy might help people with leukemia.",[27,280,281],"Leukemia, B-cell","Leukemia, T-Cell",[48,283,284,285,286,287,288],"Acute myeloid","B cell","T cell","Blood cancer","Lymph gland cancer","CD70.CAR T-cells",{"date":290,"type":57},"2025-12-16",{"date":292,"type":21},"2026-02",{"date":294,"type":21},"2042-04-01",{"name":296,"class":157},"Baylor College of Medicine",{"id":298,"slug":299,"hasResults":12,"nctId":300,"briefTitle":301,"officialTitle":302,"acronym":303,"eligibilityCriteria":304,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":305,"targetDuration":4,"studyType":254,"phases":4,"briefSummary":307,"conditions":308,"keywords":309,"overallStatus":148,"whyStopped":4,"lastUpdateSubmitDate":315,"lastUpdatePostDateStruct":316,"startDateStruct":318,"completionDateStruct":320,"leadSponsor":322,"locationsCount":4},"100613628","automated-vs-manual-flow-cytometry-gating-for-measurable-residual-disease-in-acute-myeloid-leukaemia-dualflow-100613628","NCT07269067","Automated vs Manual Flow-cytometry Gating for Measurable Residual Disease in Acute Myeloid Leukaemia (DUALFLOW)","Multicenter Retrospective Cohort Assessing Concordance Between Manual Gating and Unsupervised FlowSOM Gating for Minimal Residual Disease Detection by Multiparameter Flow Cytometry in Adult and Paediatric Acute Myeloid Leukaemia","DUALFLOW","Inclusion Criteria:\n\n* Confirmed diagnosis of acute myeloid leukaemia per ELN 2022\n* Age ≥ 18 years (adult cohort) or 0-20 years (paediatric cohort)\n* Inclusion in DATAML Bordeaux database or paediatric haemato-oncology records\n* Available flow-cytometry MRD data post-induction and post-consolidation 1\n* Non-opposition or consent for secondary use of data\n\nExclusion Criteria:\n\n* AML subtypes M3, M6 or M7\n* Acute leukaemia of ambiguous lineage\n* Missing or unusable flow-cytometry files for required time points",{"count":306,"type":21},60,"This retrospective multicentre cohort evaluates the agreement of measurable residual disease (MRD) detection in acute myeloid leukaemia (AML) using two flow-cytometry gating approaches. Manual expert gating is compared with an unsupervised FlowSOM clustering algorithm across post-induction and post-consolidation samples from 50 adults and 10 paediatric patients treated at Bordeaux University Hospital. The primary hypothesis states that unsupervised gating detects MRD ≥ 0.1 % with sensitivity and specificity comparable to manual gating.",[27],[176,310,311,312,313,314],"Minimal Residual Disease","Flow Cytometry","FlowSOM","Gating Algorithm","Machine Learning","2025-12-03",{"date":317,"type":57},"2025-12-08",{"date":319,"type":21},"2026-01",{"date":321,"type":21},"2027-07",{"name":323,"class":157},"University Hospital, Bordeaux",{"id":325,"slug":326,"hasResults":12,"nctId":327,"briefTitle":328,"officialTitle":329,"acronym":4,"eligibilityCriteria":330,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":331,"enrollmentInfo":332,"targetDuration":4,"studyType":22,"phases":334,"briefSummary":335,"conditions":336,"keywords":337,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":344,"lastUpdatePostDateStruct":345,"startDateStruct":347,"completionDateStruct":349,"leadSponsor":350,"locationsCount":132},"100460021","phase-1-single-arm-study-of-post-transplant-azacitidine-and-chidamide-for-prevention-of-acute-myelogenous-leukemia-relapse-100460021","NCT05270200","Single Arm Study of Post-transplant Azacitidine and Chidamide for Prevention of Acute Myelogenous Leukemia Relapse","To Evaluate Safety and Efficiency of AZA Combined With Chidamide as Maintenance Therapy in High-risk Acute Myeloid Leukemia Patients After Allogeneic Hematopoietic Stem Cell Transplantation：A Multicenter, Single-arm Study","Inclusion Criteria:\n\n* 1.Age 18 to 60 years old,both male and female\n* 2.Be able to understand and sign informed consent\n* 3.Patients with a diagnosis of AML not M3 according to the 2016 World Health Organization (WHO) Acute Myeloid Leukemia Classification and Diagnostic\n* 4.Patients have AML with poor genetic abnormalities,primary refractory AML,relapsed AML or secondary AML\n* 5.Patients with an ECOG performance status 0,1,2 or 3\n* 6.Expected survival time ≥ 3 months\n* 7.Non-hematological toxicity related to transplantation does not exceed Grade 2\n* 8.Laboratory indicators meet the following standards:\n\n  1. 7 days before the first day of the first course of treatment, bilirubin, ALT and AST were all less than 3 times the upper limit of normal.\n  2. Measure twice within 7 days before the first day of the first course of treatment, at least 2 days apart, the neutrophil count are greater than 1.5×10\u002FL and without G-CSF treatment.\n  3. Measure twice within 7 days before the first day of the first course of treatment, at least 2 days apart, platelet count greater than 80×10\u002FL and without platelet transfusion.\n  4. Serum creatinine clearance rate is greater than 30ml\u002Fmin.\n\nExclusion Criteria:\n\n* 1.Uncontrollable active infection\n* 2.Patients with active hepatitis B or C or HIV infection before enrollment\n* 3.Have a grade III-IV graft-versus-host disease","60 Years",{"count":333,"type":21},20,[100,24],"The goal of this clinical research study is to learn if azacitidine combined with Chidamide will help to control the disease in patients with high-risk AML after an allogeneic stem cell transplant. The safety of this combination will also be studied.",[27],[338,339,340,341,342,343],"Acute myelogenous leukemia","Allogenetic stem cell transplant","Maintenance therapy","Azacitidine","Chidamide","High-risk AML","2025-09-21",{"date":346,"type":57},"2025-09-25",{"date":348,"type":57},"2022-02-01",{"date":217,"type":21},{"name":351,"class":157},"Zhujiang Hospital",{"id":353,"slug":354,"hasResults":12,"nctId":355,"briefTitle":356,"officialTitle":357,"acronym":4,"eligibilityCriteria":358,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":359,"targetDuration":4,"studyType":22,"phases":361,"briefSummary":362,"conditions":363,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":365,"lastUpdatePostDateStruct":366,"startDateStruct":368,"completionDateStruct":370,"leadSponsor":372,"locationsCount":374},"100554600","phase-1-a-study-of-bh-30236-in-relapsed-refractory-acute-myelogenous-leukemia-and-higher-risk-myelodysplastic-syndrome-100554600","NCT06501196","A Study of BH-30236 in Relapsed\u002F Refractory Acute Myelogenous Leukemia and Higher Risk Myelodysplastic Syndrome","A Phase 1\u002F1b Open-Label, Dose Escalation, First-in- Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-leukemic Activity of the Orally Available CDC-Like Kinase (CLK) Inhibitor, BH-30236, in Adults With Relapsed or Refractory Acute Myelogenous Leukemia (R\u002FR AML) or Higher-Risk Myelodysplastic Syndrome (HR-MDS)","Inclusion criteria:\n\n* ≥18 years.\n* Diagnosis of relapsed\u002Frefractory acute myelogenous leukemia (R\u002FR) AML or higher-risk myelodysplastic syndrome (HR-MDS) with ≥5% bone marrow blast at time of inclusion.\n* Prior treatment history must include 1-5 prior lines of therapy.\n* ECOG performance status ≤2.\n* Adequate organ function evidenced by the following laboratory values:\n* Hepatic: Transaminase levels aspartate aminotransferase \\[AST\\]\u002F alanine transaminase \\[ALT\\] ≤ 2.5 × upper limit of normal (ULN). In cases of liver involvement by AML or MDS, AST and ALT \\\u003C 5.0 × ULN is acceptable. Total bilirubin ≤ 1.5 × ULN in the absence of documented Gilbert's disease.\n* Renal: Measured or calculated creatinine clearance ≥ 60 mL\u002Fmin (Cockcroft-Gault formula)\n\nThe above are a summary, other inclusion criteria details may apply.\n\nExclusion Criteria:\n\n* Diagnosis of acute promyelocytic leukemia or chronic myeloid leukemia with blast crisis.\n* Prior allogeneic HSCT within 3 months or donor lymphocyte infusion within 30 days of start of therapy;\n* Active and uncontrolled infections.\n* Unresolved AEs greater than Grade from prior therapies.\n* History of other active malignancy (with certain exceptions)\n* Prior treatment with a CLK inhibitor.\n* Any acute or chronic graft versus host disease requiring systemic therapy within 4 weeks prior to study drug administration with the exception of topical steroids or the equivalent of 20 mg of prednisone or less.\n\nThe above is a summary, other exclusion criteria details may apply.",{"count":360,"type":21},170,[100],"Study BH-30236-01 is a first-in-human (FIH), Phase 1\u002F1b, open-label, dose escalation and expansion study in participants with relapsed\u002Frefractory acute myelogenous leukemia (R\u002FR AML) or higher-risk myelodysplastic syndrome (HR-MDS).\n\nPhase 1, Part 1 Dose Escalation - Monotherapy will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of BH-30236 administered orally. Approximately 50 participants may be enrolled in Phase 1, Part 1 Dose Escalation - Monotherapy.\n\nPhase 1, Part 2 Dose Escalation - Combination with Venetoclax will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of BH-30236 administered as a combination therapy with venetoclax. Approximately 48 participants may be enrolled in Phase 1, Part 2 Dose Escalation - Combination with Venetoclax.\n\nPhase 1b (Dose Expansion) will follow Phase 1 to further understand the relationships among dose, exposure, toxicity, tolerability, and clinical activity. Up to 72 participants may be enrolled in Phase 1b of the study as a monotherapy or in combination with venetoclax.",[48,177,27,49,28,364],"Refractory Acute Myeloid Leukemia","2025-09-19",{"date":367,"type":57},"2025-09-24",{"date":369,"type":57},"2024-06-19",{"date":371,"type":21},"2027-06",{"name":373,"class":64},"BlossomHill Therapeutics",13,{"id":376,"slug":377,"hasResults":12,"nctId":378,"briefTitle":379,"officialTitle":380,"acronym":4,"eligibilityCriteria":381,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":382,"targetDuration":4,"studyType":22,"phases":384,"briefSummary":385,"conditions":386,"keywords":389,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":391,"lastUpdatePostDateStruct":392,"startDateStruct":394,"completionDateStruct":396,"leadSponsor":398,"locationsCount":132},"100462759","phase-2-venetoclax-combining-chidamide-and-azacitidine-vca-in-the-treatment-of-rr-aml-100462759","NCT05305859","Venetoclax Combining Chidamide and Azacitidine (VCA) in the Treatment of R\u002FR AML","A Multi-center, Prospective, Single-arm Study of Venetoclax Combining Chidamide and Azacitidine (VCA) in the Treatment of Refractory\u002FRelapsed Acute Myelogenous Leukemia (R\u002FR AML)","Inclusion Criteria:\n\n* Age ≥18\n* Relapsed and refractory patients with acute myeloid leukemia via morphology and immunology\n* ECOG：0-2\n* Life expectancy ≥ 3 months\n* Adequate laboratory parameters during the screening period as evidenced by the following:\n\n  1. Creatinine clearance≥30 mL\u002Fmin and serum Creatinine ≤ 160µmol\u002FL\n  2. ALT and AST ≤ 3 × upper limit of normal (ULN)\n  3. Able to understand and sign an informed consent form (ICF).\n\nExclusion Criteria:\n\n* Diagnosis of acute promyelocytic leukemia (APL)\n* Central nervous system leukemia\n* Uncontrolled or significant cardiovascular disease, including any of the following:\n\n  1. Bradycardia of less than 50 beats per minute, unless the subject has a pacemaker; Diagnosis of or suspicion of long QT syndrome (including family history of long QT syndrome);\n  2. Systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg; History of clinically relevant ventricular arrhythmias (eg, ventricular tachycardia, ventricular fibrillation, or Torsade de Pointes);\n  3. History of second (Mobitz II) or third degree heart block (subjects with pacemakers are eligible if they have no history of fainting or clinically relevant arrhythmias while using the pacemaker);\n  4. History of uncontrolled angina pectoris or myocardial infarction within 6 months prior to Screening;\n  5. History of New York Heart Association Class 3 or 4 heart failure;\n  6. Complete left bundle branch block;\n  7. Known history of left ventricular ejection fraction (LVEF) ≤45% or less than the institutional lower limit of normal;\n* Active acute or chronic systemic fungal, bacterial, or viral infection not well controlled by antifungal, antibacterial or antiviral therapy;\n* Suffered from other non-myeloid malignancies within 2 years, except adequately treated non-melanoma skin cancer, curatively treated in-situ disease, or other solid tumors curatively treated with no evidence of disease\n* Females who are pregnant or breastfeeding;\n* Mental disorders that hinder research participation\n* Previous solid organ transplantation (SCT treatment is allowed in advance, but if the patient has GVHD or is still receiving immunosuppression\u002FGVHD treatment, it is not allowed)\n* Any other situation where the investigator believes that the patient should not participate in this trial",{"count":383,"type":21},30,[24],"The purpose of this study is to evaluate the safety and efficacy of Venetoclax Combining Chidamide and Azacitidine (VCA) in the Treatment of relapsed and\u002For refractory AML",[27,387,388],"Relapsed Adult AML","Refractory Leukemia",[390],"refractory\u002Frelapsed acute myelogenous leukemia","2025-09-04",{"date":393,"type":57},"2025-09-11",{"date":395,"type":57},"2022-01-12",{"date":397,"type":21},"2027-06-30",{"name":399,"class":157},"The First Affiliated Hospital of Xiamen University",{"id":401,"slug":402,"hasResults":12,"nctId":403,"briefTitle":404,"officialTitle":405,"acronym":4,"eligibilityCriteria":406,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":407,"targetDuration":4,"studyType":22,"phases":409,"briefSummary":410,"conditions":411,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":412,"lastUpdatePostDateStruct":413,"startDateStruct":415,"completionDateStruct":417,"leadSponsor":418,"locationsCount":420},"100545458","phase-1-dfp-10917-in-combination-with-venetoclax-in-relapsed-or-refractory-acute-myeloid-leukemia-100545458","NCT06382168","DFP-10917 in Combination With Venetoclax in Relapsed or Refractory Acute Myeloid Leukemia","Phase I\u002FII Study of DFP-10917 in Combination With Venetoclax in Relapsed or Refractory Acute Myeloid Leukemia","Inclusion Criteria:\n\n* Signed informed consent and ability to comply with protocol requirements.\n* Histologically or pathologically confirmed diagnosis of acute myeloid leukemia based on World Health Organization classification that has relapsed after, or is refractory to, up to 2 prior induction regimens that may have included intensive chemotherapy (e.g., \"7+3\" cytarabine and daunorubicin), epigenetic therapy (i.e., azacitidine or decitabine with\u002Fwithout venetoclax), or targeted therapy (e.g., FLT-3, IDH 1\u002F2, BCL-2, monoclonal antibody).\n\n(Relapse is defined as reemergence of ≥5% leukemia blasts in bone marrow or ≥1% blasts in peripheral blood 90 days to 24 months after first complete remission or complete remission with incomplete hematologic recovery. Refractory acute myeloid leukemia is defined as persistent disease ≥28 days after initiation of intensive induction therapy (up to 2 induction cycles) or relapse \\\u003C90 days after first complete remission or complete remission with incomplete hematologic recover. Refractory disease for patients undergoing hypomethylating agent induction is defined as lack of remission following at least 2 cycles of epigenetic therapy without reduction in bone marrow blast status).\n\n* Adequate organ function as defined by the following laboratory values:\n\n  * Creatinine clearance \\>30 mL\u002Fmin (by Cockcroft-Gault method),\n  * Total serum bilirubin \\\u003C1.5 × upper limit of normal unless due to Gilbert's syndrome, leukemic organ involvement, hemolysis or considered an effect of regular blood transfusions,\n  * Alanine aminotransferase and aspartate aminotransferase \\\u003C3 × upper limit of normal, unless due to leukemic organ involvement.\n* Eastern Cooperative Oncology Group performance status of 0, 1, or 2).\n* Projected life expectancy of ≥12 weeks.\n* Female patients of childbearing potential must:\n\n  * Have a negative serum or urine pregnancy test prior to study treatment initiation.\n  * Agree to use at least 1 highly effective form of contraception during study treatment and for 3 months after the last dose.\n* Male patients with female partners of childbearing potential must -- Agree to use at least 1 highly effective form of contraception during study treatment and for at least 3 months after the last dose.\n\nExclusion Criteria:\n\n* Any \\>Grade 1 persistent clinically significant toxicities from prior chemotherapy.\n* Leukemic blast count \\>25 × 109\u002FL. Hydroxyurea permitted to control leukocytosis.\n* Known history of human immunodeficiency virus or active hepatitis B or active hepatitis C infection.\n* Concomitant malignancies for which patients are receiving active therapy at the time of signing consent. Patients with adequately treated basal or squamous cell carcinoma of the skin, adequately treated carcinoma in situ (e.g., cervix), breast cancer receiving adjuvant endocrine therapy or prostate cancer not under active systemic treatment other than hormonal therapy may enroll irrespective of the time of diagnosis, with Medical Monitor approval.\n* Known active central nervous system involvement by leukemia. Patients with previously diagnosed central nervous system leukemia are eligible if the central nervous system leukemia is under control and intrathecal treatment may continue throughout the study.\n* Diagnosis of acute promyelocytic leukemia.\n* Prior exposure to anticancer therapies including chemotherapy, radiotherapy or other investigational therapy, including targeted small molecule agents within 14 days of the first day of study treatment or within 5 half-lives prior to first dose of study treatment. Note that hydroxyurea up to 5 g daily × 3 days is permitted to reduce elevated white blood cell (WBC) count.\n* Venetoclax exposure in more than 1 prior regimen.\n* Prior exposure to biologic agents (e.g., monoclonal antibodies) for anti-neoplastic intent within 14 days prior to first dose of study drug.\n* Prior hematopoietic stem cell transplantation.\n* Malabsorption syndrome or other condition that precludes enteral route of administration.\n* Pregnancy or lactation.\n* Active uncontrolled systemic infection (viral, bacterial, or fungal).\n* Ongoing treatment with strong or moderate CYP3A inhibitors or CYP3A inducers, P-gp inhibitors, or narrow therapeutic index P-gp substrates that cannot be discontinued at least 1 week prior to start of venetoclax dosing excluding antifungal prophylaxis.",{"count":408,"type":21},39,[100,24],"This Phase I\u002FII trial evaluates the safety and preliminary efficacy of DFP-10917 combined with venetoclax in relapsed or refractory acute myeloid leukemia. DFP-10917 is given as a 14-day continuous IV infusion every 28 days, alongside a 14-day oral course of venetoclax following an initial dose ramp-up. The initial phase tests a starting dose of 4 mg\u002Fm²\u002Fday of DFP-10917 with 400 mg daily of venetoclax. The Data Monitoring Committee reviews toxicity after one treatment cycle. If DLTs are minimal, more patients are added to confirm safety. If the lower dose level shows tolerability, it proceeds to the Phase II expansion to assess the treatment's effectiveness against leukemia using a Simon's two-stage design, targeting up to 17 participants.",[27],"2025-08-31",{"date":414,"type":57},"2025-09-03",{"date":416,"type":57},"2024-06-12",{"date":152,"type":21},{"name":419,"class":64},"Delta-Fly Pharma, Inc.",4,{"id":422,"slug":423,"hasResults":12,"nctId":424,"briefTitle":425,"officialTitle":426,"acronym":427,"eligibilityCriteria":428,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":429,"targetDuration":4,"studyType":22,"phases":431,"briefSummary":432,"conditions":433,"keywords":437,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":446,"lastUpdatePostDateStruct":447,"startDateStruct":449,"completionDateStruct":451,"leadSponsor":453,"locationsCount":455},"100351035","phase-1-clinical-trial-to-evaluate-the-safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-tuspetinib-hm43239-in-patients-with-relapsed-or-refractory-acute-myeloid-leukemia-100351035","NCT03850574","Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Tuspetinib (HM43239) in Patients With Relapsed or Refractory Acute Myeloid Leukemia","A Phase 1\u002F2 Open Label, Multicenter, Dose Escalation and Expansion Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM43239 in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)","TUSCANY","Inclusion Criteria for Parts A\u002FB\u002FC:\n\n* Study participant is defined as having morphologically documented primary or secondary AML, MDS-IB2 (≥ 10% bone marrow blasts), or CMML by the World Health Organization (WHO) criteria (2016), and fulfills one of the following:\n\n  1. Refractory to at least 1 cycle of prior therapy\n  2. Relapsed after achieving remission with a prior therapy\n* Study participant has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.\n* Study participant's interval from prior treatment to time of study drug administration is at least 2 weeks for cytotoxic agents (except hydroxyurea given for controlling blast cells), at 4 weeks for biologic or cellular immunotherapies, or least 5 half-lives for prior experimental agents or noncytotoxic agents, including immunosuppressive therapy post hematopoietic stem cell transplantation (HSCT). Upon discussion with the Medical Monitor, a shorter than stated washout period may be considered provided that the study participant has recovered from any clinically relevant safety issue and recovered to Grade ≤ 1 toxicity from prior therapies.\n* Study participant must meet the following criteria as indicated on the clinical laboratory tests.\n\n  1. Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3× institutional upper limit normal (ULN)\n  2. Total serum bilirubin ≤ 1.5× institutional ULN\n  3. Creatinine clearance as calculated by the Cockcroft-Gault formula or measured by 24-h urine collection of \\> 45 mL\u002Fmin.\n* Study participant is suitable for oral administration of study drug and has minimum life expectancy (≥ 3 months)\n* Female study participants must be either:\n* Of non-childbearing potential\n\n  1. Post-menopausal (defined as at least 1 year without any menses) prior to screening, or\n  2. Documented surgically sterile or status post hysterectomy (at least 1 month prior to screening)\n* Or, if of childbearing potential,\n\n  1. Must have a negative serum or urine pregnancy test at screening (within 72 hours prior to start of treatment), and\n  2. Must use an acceptable highly effective method of birth control starting at screening and throughout the study period and for 90 days after the final study drug administration.\n* Female study participants must not be breastfeeding at screening and during the study period, and for 90 days after the final study drug administration\n* Female study participants must not donate ova starting at screening and throughout the study period, and for 90 days after the final study drug administration.\n* Male study participants and their female spouse\u002Fpartners who are of childbearing potential must be using highly effective contraception starting at screening and continue throughout the study period and for 90 days after the final study drug administration.\n* Male study participants must not donate sperm starting at screening and throughout the study period and for 90 days after the final study drug administration.\n* Study participant agrees not to participate in another interventional study while on treatment.\n\nExclusion Criteria for Parts A\u002FB\u002FC:\n\nStudy participants must not enter the study if any of the following exclusion criteria are met:\n\n* Study participant was diagnosed with acute promyelocytic leukemia (APL).\n* Study participant has known BCR-ABL-positive leukemia.\n* Study participant has an active malignancy other than AML, MDS-IB2, or CMML.\n* Study participant has persistent non-hematological toxicities of ≥ Grade 2 (CTCAE v4.03), with symptoms and objective findings, from prior AML, MDS-IB2, or CMML treatment (including chemotherapy, kinase inhibitors, immunotherapy, experimental agents, radiation, or surgery)\n* Study participant has had hematopoietic stem cell transplant (HSCT) and meets any of the following criteria:\n\n  1. Has undergone HSCT within the 2-month period prior to the first study dose\n  2. Has clinically significant graft-versus-host-disease (GVHD) requiring treatment\n  3. Has ≥ Grade 2 persistent non-hematological toxicity related to the transplant\n  4. Had a donor lymphocyte infusion (DLI) ≤ 30 days prior to the first study dose.\n* Study participant has meningeal or central nervous system (CNS) involvement with leukemia or other CNS disease related to underlying and secondary effects of malignancy.\n* Study participant has disseminated intravascular coagulation abnormality (DIC).\n* Study participant has had major surgery within 4 weeks prior to the first study dose.\n* Study participant has had radiation therapy within 4 weeks prior to the first study dose.\n* Study participant has congestive heart failure New York Heart Association (NYHA) class 3 or 4, or study participant with a history of congestive heart failure NYHA class 3 or 4 in the past, unless a screening echocardiogram or multigated acquisition (MUGA) scan performed within 3 months prior to study entry results in a left ventricular ejection fraction (LVEF) that is ≥ 45%.\n* Study participant has any of the following cardiac abnormalities of history:\n\n  1. Study participant has any clinically important abnormalities in rhythm, conduction or morphology of resting ECG, e.g., complete left bundle branch block, third-degree heart block, second-degree heart block, or PR interval \\> 250 milliseconds (ms).\n  2. Study participant has a mean QT interval (QTc) by Friderica's method (QTcF) \\> 450 ms in three successive screening measurements.\n  3. Study participant has any factors that increase the risk of QTc prolongation or risk of arrhythmic events, such as congenital long QT, syndrome, family history of long QT syndrome.\n* Study participant is known to have active infection including any identified active COVID-19 infection.\n* Study participant is known to have human immunodeficiency virus infection.\n* Study participant has known active hepatitis B or C, or other active hepatic disorder.\n* Study participant has any condition which, in the Investigator's opinion, makes the study participant unsuitable for study participation.\n* Study participant has a history of Grade 3 or 4 non-hematologic toxicity related to tyrosine kinase inhibitor.\n\nInclusion Criteria for Part D:\n\n* Study participant is defined as having morphologically documented newly diagnosed previously untreated primary or secondary AML by the World Health Organization (WHO) criteria (2016) and considered ineligible to receive intensive chemotherapy.\n\nStudy participants ≥ 75 years of age are considered ineligible to receive intensive chemotherapy if they meet any of the following criteria:\n\n1. ECOG Performance Status of 2 or 3;\n2. Cardiac history of congestive heart failure (CHF) requiring treatment or ejection fraction ≤ 50% or chronic stable angina;\n3. Diffusing capacity of the lung for carbon monoxide (DLCO) ≤ 65% or forced expiratory volume during the first second (FEV1) ≤ 65%;\n4. Creatinine clearance ≥ 30 mL\u002Fmin to \\\u003C 45 ml\u002Fmin;\n5. Moderate hepatic impairment with total bilirubin \\> 1.5 to ≤ 3.0×ULN;\n6. Any other comorbidity that the Investigator judges to be incompatible with intensive chemotherapy must be reviewed and approved by the Medical Monitor during screening and prior to treatment.\n\nStudy participants are considered ineligible to receive intensive chemotherapy based on their age being ≥ 75 years.\n\n* Study participant \\\u003C 75 years has an ECOG performance status ≤ 2; study participant ≥ 75 years has an ECOG performance status 0-2.\n* Study participant must meet the following criteria as indicated on the clinical laboratory tests:\n\n  1. Serum AST and ALT ≤ 3× institutional ULN unless considered due to leukemic organ involvement.\n  2. Total serum bilirubin ≤ 3x institutional ULN unless considered due to leukemic organ involvement for study participants \\\u003C 75 years; total serum bilirubin ≤ 1.5x institutional ULN (or ≤ 3x institutional ULN if documented history of Gilbert's syndrome) unless considered due to leukemic organ involvement for study participants ≥ 75 years.\n  3. Creatinine clearance as calculated by the Cockcroft-Gault formula or measured by 24-h urine collection of ≥ 30 mL\u002Fmin for study participants \\\u003C 75 years; creatinine clearance as calculated by the Cockcroft-Gault formula or measured by 24-h urine collection of ≥ 45 mL\u002Fmin for study participants ≥ 75 years.\n* Study participant is suitable for oral administration of study drug and has minimum life expectancy (≥ 3 months)\n* Female study participants must be either:\n* Of non-childbearing potential\n\n  1. Post-menopausal (defined as at least 1 year without any menses) prior to screening, or\n  2. Documented surgically sterile or status post hysterectomy (at least 1 month prior to screening)\n* Or, if of childbearing potential,\n\n  1. Must have a negative serum or urine pregnancy test at screening (within 72 hours prior to start of treatment), and\n  2. Must use an acceptable highly effective contraception starting at screening and throughout the study period and for 90 days after the final study drug administration.\n* Female study participants must not be breastfeeding at screening and during the study period, and for 90 days after the final study drug administration.\n* Female study participants must not donate ova starting at screening and throughout the study period, and for 90 days after the final study drug administration.\n* Male study participants and their female spouse\u002Fpartners who are of childbearing potential must be using highly effective contraception starting at screening and continue throughout the study period and for 90 days after the final study drug administration.\n* Male study participants must not donate sperm starting at screening and throughout the study period and for 90 days after the final study drug administration.\n* Study participant agrees not to participate in another interventional study while on treatment.\n\nExclusion Criteria for Part D:\n\nStudy participants must not enter the study if any of the following exclusion criteria are met:\n\n* Study participant was diagnosed with acute promyelocytic leukemia (APL).\n* Study participant has known BCR-ABL-positive leukemia.\n* Study participant has an active malignancy other than AML.\n* Study participant has received treatment with the following:\n\n  1. An HMA, VEN (or other BCL-2 inhibitor), a tyrosine kinase inhibitor (TKI), a FLT3 inhibitor (FLT3i), a hematopoietic stem cell transplant (HSCT), and\u002For a chemotherapeutic agent for antecedent myeloid neoplasm (Note: Prior chemotherapy for solid tumors considered in remission is allowed.)\n  2. CAR-T cell therapy\n  3. Experimental therapies for antecedent myeloid neoplasms\n  4. Current participation in another research or observational study\n* Study participant has persistent non-hematological toxicities of ≥ Grade 2 (CTCAE v4.03), with symptoms and objective findings, from treatment for antecedent myeloid neoplasms (including chemotherapy, kinase inhibitors, immunotherapy, experimental agents, immunosuppressive therapy, radiation, or surgery).\n* Study participant has meningeal or central nervous system (CNS) involvement with leukemia or other CNS disease related to underlying and secondary effects of malignancy.\n* Study participant has disseminated intravascular coagulation abnormality (DIC).\n* Study participant has had major surgery within 4 weeks prior to the first study dose.\n* Study participant has had radiation therapy within 4 weeks prior to the first study dose.\n* Study participant has congestive heart failure New York Heart Association (NYHA) class 3 or 4, or study participant with a history of congestive heart failure NYHA class 3 or 4 in the past, unless a screening echocardiogram or multigated acquisition (MUGA) scan performed within 3 months prior to study entry results in a left ventricular ejection fraction (LVEF) that is ≥ 45%.\n* Study participant has any of the following cardiac abnormalities of history:\n\n  1. Study participant has any clinically important abnormalities in rhythm, conduction or morphology of resting ECG, e.g., complete left bundle branch block, third-degree heart block, second-degree heart block, or PR interval \\> 250 milliseconds (ms).\n  2. Study participant has a mean QT interval (QTc) by Friderica's method (QTcF) \\> 450 ms in three successive screening measurements.\n  3. Study participant has any factors that increase the risk of QTc prolongation or risk of arrhythmic events, such as congenital long QT, syndrome, family history of long QT syndrome.\n* Study participant is known to have active infection, including any identified active COVID-19 infection.\n* Study participant is known to have human immunodeficiency virus infection.\n* Study participant has known active hepatitis B or C, or other active hepatic disorder.\n* Study participant has any condition which, in the Investigator's opinion, makes the study participant unsuitable for study participation, including a chronic respiratory disease that requires continuous oxygen, or a significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, hepatic, or cardiovascular disease, or any other medical condition or known hypersensitivity to any of the study medications including excipients of VEN and AZA that in the opinion of the Investigator would adversely affect participating in this study.\n* Study participant exhibits evidence of other clinically significant uncontrolled systemic infection requiring therapy (viral, bacterial, or fungal) or other medical conditions (e.g., infection, heart failure, COPD flare, etc.).\n* Study participant has a white blood cell count \\> 25 × 10\\^9\u002FL. (Treatment with hydroxyurea or use of leukapheresis are permitted to meet this criterion.)",{"count":430,"type":21},240,[100,24],"The main purpose of this study is to identify a safe and potentially effective dose of tuspetinib to be used in future studies in study participants diagnosed with acute myeloid leukemia (AML), myelodysplastic syndromes with increased blasts grade 2 (MDS-IB2), or chronic myelomonocytic leukemia (CMML) that is relapsed or refractory after at least one line of prior therapy, or in study participants with newly diagnosed AML. Tuspetinib will be administered as a single agent or in combination with other drugs (venetoclax or venetoclax plus azacitidine), as specified for each part of the study.",[27,434,387,435,436],"Refractory AML","Myelodysplastic Syndrome With Excess Blasts-2","Chronic Myelomonocytic Leukemia",[438,176,170,439,440,441,442,436,443,444,341,445],"Tuspetinib","Relapsed","Refractory","Myelodysplastic Syndromes with Increased Blasts Grade 2","MDS-IB2","CMML","Venetoclax","Newly Diagnosed","2025-08-20",{"date":448,"type":57},"2025-08-26",{"date":450,"type":57},"2019-03-11",{"date":452,"type":21},"2027-04",{"name":454,"class":64},"Aptose Biosciences Inc.",34,{"id":457,"slug":458,"hasResults":12,"nctId":459,"briefTitle":460,"officialTitle":461,"acronym":462,"eligibilityCriteria":463,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":464,"targetDuration":4,"studyType":22,"phases":466,"briefSummary":467,"conditions":468,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":469,"lastUpdatePostDateStruct":470,"startDateStruct":472,"completionDateStruct":474,"leadSponsor":476,"locationsCount":132},"100511930","phase-1-cd33ko-hspc-infusion-followed-by-cart-33-infusions-for-refractoryrelapsed-aml-100511930","NCT05945849","CD33KO-HSPC Infusion Followed by CART-33 Infusion(s) for Refractory\u002FRelapsed AML","Phase 1 Study of Lentivirally Transduced T Cells Engineered to Contain Anti-CD33 Linked to TCRζ And 4-1BB Signaling Domains In Combination With CD33KO-HSPC In Subjects With Refractory Or Relapsed Acute Myeloid Leukemia","CART33","Inclusion Criteria:\n\n1. Male or female 18 years of age or older\n2. Subjects with AML unlikely to be cured with currently available therapies\n\n   1. AML that has not achieved a complete remission or morphologic leukemia free state by ELN criteria; partial remission or refractory disease (including primary refractory) are eligible; OR:\n   2. AML relapsed following allogeneic stem cell transplantation (including MDS evolved to AML post-allogeneic stem cell transplantation). Note: morphologic relapse is not required; persistent\u002Frecurrent disease-associated molecular, phenotypic or cytogenetic abnormalities (measurable residual disease, MRD) at any time after allogeneic HCT is eligible; OR:\n   3. Subjects with relapsed disease after prior transplant must be off systemic immunosuppression for at least 1 month at the time of enrollment.\n3. Subjects must have a suitable stem cell donor.\n4. Satisfactory organ function\n\n   1. Creatinine clearance \\> 40 ml\u002Fmin\n   2. ALT\u002FAST must be ≤ 5x upper limit of normal unless related to disease and \\\u003C 20 x upper limit of normal if related to disease\n   3. Direct bilirubin \\\u003C 2.0 mg\u002Fdl, unless subject has Gilbert's syndrome (≤ 3.0 mg\u002FdL)\n5. Left ventricular ejection fraction ≥ 40% as confirmed by echocardiogram or MUGA\n6. DLCO \\> 45% predicted\n7. ECOG performance status 0-1\n8. Written informed consent is given\n9. Subjects of reproductive potential must agree to use acceptable birth control methods\n\nExclusion Criteria:\n\n1. Pregnant or lactating (nursing) women\n2. Active hepatitis B or hepatitis C or HIV infection\n3. Concurrent use of systemic steroids or immunosuppressant medications\n4. Any uncontrolled active medical disorder that would preclude participation as outlined\n5. Subjects with signs or symptoms indicative of CNS involvement.\n6. Known history of allergy or hypersensitivity to study product excipients (human serum albumin, DMSO, and Dextran 40)\n7. Class III\u002FIV cardiovascular disability according to New York Heart Association Classification\n8. Subjects with a known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system, and unrelated to leukemia or previous leukemia treatment.\n9. Subjects with clinically apparent arrhythmia, or arrhythmias that are not stable on medical management, within 2 weeks of the screening\u002Fenrollment visit.",{"count":465,"type":21},16,[100],"The purpose of this study is to provide a new type of treatment for AML. This treatment combines a new type of stem cell transplant along with treatment using chimeric antigen receptor (CAR) T cells that have been engineered to recognize and attack your AML cells.\n\nThe first treatment is a modified stem cell transplant, using blood-forming stem cells donated from a healthy donor. From the same donor, we will also make CAR T-cells, which are leukemia fighting cells, which will be given to the patient via an infusion into the vein after the transplanted stem cells have started to grow healthy blood cells. The modification of the stem cell transplant means that the healthy bone marrow cells will be \"invisible\" to the CAR T-cells that are trying to kill the leukemia cells.",[27],"2025-06-25",{"date":471,"type":57},"2025-06-29",{"date":473,"type":57},"2024-02-23",{"date":475,"type":21},"2044-02-23",{"name":477,"class":157},"University of Pennsylvania",{"id":479,"slug":480,"hasResults":12,"nctId":481,"briefTitle":482,"officialTitle":482,"acronym":4,"eligibilityCriteria":483,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":484,"targetDuration":486,"studyType":254,"phases":4,"briefSummary":487,"conditions":488,"keywords":489,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":491,"lastUpdatePostDateStruct":492,"startDateStruct":494,"completionDateStruct":496,"leadSponsor":498,"locationsCount":132},"100589618","registry-of-myelodysplastic-syndromes-and-therapy-related-acute-myeloid-leukemia-100589618","NCT06956755","Registry of Myelodysplastic Syndromes and Therapy-related Acute Myeloid Leukemia","Inclusion Criteria:\n\n* Male or female\n* Age \\> 18 years\n* Patients with myelodysplastic syndrome and therapy-related acute myeloid leukemia\n* Able and willing to provide written informed consent\n\nExclusion Criteria:\n\n* Age \\\u003C18 years\n* Patient is unwilling or unable to give consent",{"count":485,"type":21},6990,"6 Months","The Registry MDS is an ongoing, observational study that has collected longitudinal data on diagnostics, demographics, clinical parameters, and health Care Interventions (HCI) from patients with MDS and therapy-related acute myeloid leukemia",[28,27],[209,490],"t-AML","2025-05-02",{"date":493,"type":57},"2025-05-06",{"date":495,"type":57},"2003-07-07",{"date":497,"type":21},"2031-01-05",{"name":499,"class":157},"Groupe Francophone des Myelodysplasies",{"id":501,"slug":502,"hasResults":12,"nctId":503,"briefTitle":504,"officialTitle":505,"acronym":4,"eligibilityCriteria":506,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":507,"enrollmentInfo":508,"targetDuration":4,"studyType":22,"phases":510,"briefSummary":511,"conditions":512,"keywords":513,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":516,"lastUpdatePostDateStruct":517,"startDateStruct":519,"completionDateStruct":521,"leadSponsor":522,"locationsCount":524},"100525211","phase-1-phase-i-clinical-study-bg1805-injection-in-the-treatment-of-relapsed-or-refractory-acute-myeloid-leukemia-100525211","NCT06118788","Phase I Clinical Study: BG1805 Injection in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia","A Single-arm, Dose-escalation and Dose-expansion Phase I Clinical Study to Evaluate the Tolerability, Safety and Preliminary Efficacy of BG1805 Injection in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent and be expected to complete the follow-up examination and treatment of the study procedures.\n2. Age of 18-70 years old (inclusive of the cut-off value), regardless of gender.\n3. Conforming to the diagnosis of AML according to the 2016 WHO classification, and conforming to the diagnostic criteria of relapsed and refractory acute myeloid leukemia in Chinese Guidelines for the Diagnosis and Treatment of relapsed and refractory acute myeloid Leukemia (2017 edition) :\n\n   1. Relapsed AML diagnostic criteria: the reappearance of peripheral blood or bone marrow blasts after complete remission (CR); 5% (excluding other causes such as bone marrow regrowth after consolidation chemotherapy) or extramedullary leukemic cell infiltration.\n   2. Refractory AML diagnostic criteria: newly diagnosed patients who failed to response to 2 courses of standard regimens; Patients who relapsed within 12 months after consolidation and intensive therapy; Patients relapsed after 12 months but failed to respond to conventional chemotherapy; Patients with two or more recurrences; Patients with persistent extramedullary leukemia.\n4. Flow cytometry confirmed the AML Blast CLL-1 expression positive (CLL-1 expression ≥50%).\n5. The patient has recovered from the toxicity of previous treatment, defined as CTCAE toxicity grade \\\u003C2 (unless the abnormality is tumor-related or is judged by the investigator to be stable and has little effect on safety or efficacy).\n6. ECOG performance status of 0-1 and predicted survival of more than 3 months.\n7. Have appropriate organ functions:\n\n   * Aspartate aminotransferase (AST) ≤3 times the upper limit of normal (ULN)\n   * Alanine aminotransferase (ALT) ≤3 times ULN\n   * Total bilirubin ≤1.5 times ULN\n   * Serum creatinine ≤1.5 times ULN or creatinine clearance ≥60 mL\u002F minute\n   * Hemoglobin ≥60g\u002FL or maintained at that level after transfusion\n   * Refers to terminal oxygen saturation ≥92%\n   * Left ventricular ejection fraction (LVEF) ≥45%\n8. Female subjects were also considered for inclusion if they met the following criteria:\n\n   1. Infertility, defined as:\n\n      * Prior hysterectomy or bilateral oophorectomy, or\n      * Prior bilateral tubal ligation, or\n      * Menopausal (≥ 1 year of complete amenorrhea)\n   2. be fertile, but have a negative serum pregnancy test at screening, and agree to use a medically approved contraceptive method (e.g., an intrauterine device, contraceptive pill, or condom) before and during study enrollment and up to 1 year after the last study use.\n9. Men of childbearing potential had to agree to barrier contraception or complete abstinence until 1 year after the last study dose.\n\nExclusion Criteria:\n\n1. Acute promyelocytic leukemia was diagnosed.\n2. Have other malignant tumors within 3 years before screening, excluding adequately treated cervical carcinoma in situ, papillary thyroid carcinoma, basal cell or squamous cell skin cancer, local prostate cancer after radical prostatectomy, and ductal carcinoma in situ after radical prostatectomy.\n3. Evidence of central nervous system involvement or cranial neuropathy.\n4. Hepatitis B surface antigen (HBsAg) positive, hepatitis B core antibody (HBcAb) positive and peripheral blood HBV-DNA higher than the detection limit; Hepatitis C virus (HCV) antibody positive; Persons with human immunodeficiency virus (HIV) antibody positive; Cytomegalovirus (CMV) DNA positive cases; EBV-DNA positive patients; The syphilis antibody was positive.\n5. Those with a history of anaphylaxis \\[A history of anaphylaxis was defined as an allergic reaction of grade 2 or higher, in which any of the following clinical manifestations occurred: Airway obstruction (rhinorrhea, cough, stridor, dyspnea), Tachycardia, Hypotension, Arrhythmia, Gastrointestinal symptoms (nausea, vomiting), Incontinence, Laryngeal edema, Bronchospasm, Cyanosis, Shock, Respiratory, cardiac arrest\\] or known to be allergic to any of the drug active ingredients, excipents, or mouse-derived products or xenoproteins included in this trial (including the lymphatic cells clearance protocol).\n6. Have severe cardiac disease, including but not limited to severe arrhythmia, unstable angina, massive myocardial infarction, New York Heart Association class III or IV cardiac dysfunction, and refractory hypertension.\n7. Previous organ transplantation or preparation for organ transplantation (excluding hematopoietic stem cell transplantation).\n8. Acute and chronic graft-versus-host disease (GVHD).\n9. Patients who had undergone hematopoietic stem-cell transplantation within 6 months before screening.\n10. Active autoimmune or inflammatory diseases (e.g., Guillain-Barre syndrome (GBS), amyotrophic lateral sclerosis (ALS)) and clinically significant active cerebrovascular diseases (e.g., cerebral edema, posterior reversible encephalopathy syndrome (PRES)).\n11. Patients with cancer emergencies (such as spinal cord compression, intestinal obstruction, leukostasis, tumor lysis syndrome, etc.) requiring emergency treatment before screening or reinfusion.\n12. Presence of uncontrolled bacterial, fungal, viral, or other infection requiring antibiotic treatment.\n13. Patients who had undergone major surgery (excluding diagnostic surgery and biopsy) within 4 weeks before lymphatic cells clearance or planned to undergo major surgery during the study period, or who had not fully healed the surgical wound before enrollment.\n14. Persons with severe mental illness.\n15. Within 1 week before the collection of peripheral blood mononuclear cells (PBMC), patients who use granulocyte colony-stimulating factor (G-CSF), granulocyte macrophage colony-stimulating factor (GM-CSF) and other hematopoietic cytokine drugs that have an impact on the patient's blood picture (if it is a long-acting preparation, it is 2 weeks) and have an impact on cell preparation as judged by the investigator .\n16. Within 2 weeks before PBMC collection, patients were receiving hormonal or immunosuppressive drugs that were judged by the investigator to have an effect on cell production.\n\n    1. hormone: subjects who were receiving systemic steroid therapy within 2 weeks before PBMC collection and who required long-term systemic steroid therapy (except inhaled or topical use) as judged by the investigator during the treatment.\n    2. Immunosuppressive agents: those who were receiving immunosuppressive agents within 2 weeks before PBMC collection.\n17. Vaccination with live (attenuated) virus vaccine within 4 weeks prior to screening.\n18. Alcoholics or those with a history of substance abuse.\n19. Participate in other clinical investigators within 3 months.\n20. Subjects who have received other CAR-T therapy or cell therapy in the past.\n21. Patients who, in the investigator's judgment and\u002For clinical criteria, have contraindications to any study procedure or other medical conditions that may put them at unacceptable risk.","70 Years",{"count":509,"type":21},24,[100,24],"This is a single-arm, single-dose dose-escalation and dose-expansion study.",[27],[514,170,515],"CAR-T","CLL1","2025-04-15",{"date":518,"type":57},"2025-04-17",{"date":520,"type":57},"2024-03-07",{"date":321,"type":21},{"name":523,"class":64},"Guangzhou Bio-gene Technology Co., Ltd",3,{"id":526,"slug":527,"hasResults":12,"nctId":528,"briefTitle":529,"officialTitle":530,"acronym":4,"eligibilityCriteria":531,"healthyVolunteers":12,"sex":17,"minAge":331,"maxAge":4,"enrollmentInfo":532,"targetDuration":4,"studyType":22,"phases":534,"briefSummary":535,"conditions":536,"keywords":538,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":542,"lastUpdatePostDateStruct":543,"startDateStruct":545,"completionDateStruct":547,"leadSponsor":549,"locationsCount":132},"100485654","phase-2-vca-regimen-followed-by-d-mag-regimen-on-the-treatment-of-elderly-patients-with-newly-diagnosed-acute-myeloid-leukemia-aml-100485654","NCT05603884","VCA Regimen Followed by D-MAG Regimen on the Treatment of Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)","Venetoclax Combining Chidamide and Azacitidine (VCA) Regimen Followed by Dicitabine Combined With Liposome Mitoxantrone, Cytarabine, and G-CSF (D-MAG) Regimen on the Treatment of Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) : A Multicenter, Prospective, Single Arm Clinical Trial","Inclusion Criteria:\n\n* 1\\) Histologically confirmed acute myeloid leukemia (non-M3). Treatment-na?ve and unable to receive standard cytarabine and anthracycline induction regimens due to age or comorbidities or patient preference.\n\n  2\\) Age ≥ 60 years old, male or female, with an expected survival more than 3 months.\n\n  3\\) Estimated creatinine clearance ≥ 30 mL\u002Fmin. 4) AST and ALT ≤ 3.0 x ULN (unless leukemic organ involvement). Bilirubin ≤ 1.5 x ULN (unless considered due to leukemic organ involvement).\n\n  5\\) ECOG ≤ 2. 6) Able to understand and voluntarily provide informed consent.\n\nExclusion Criteria:\n\n* 1)Acute promyelocytic leukemia (APL) and low risk cytogenetics such as t(8;21), inv(16) or t(16;16).\n\n  2\\) Active central nervous system leukemia. 3) History of myeloproliferative neoplasm (MPN) including myelofibrosis, essential thrombocythemia, polycythemia vera, chronic myeloid leukemia (CML) with or without BCR-ABL1 translocation and AML with BCR- ABL1 translocation.\n\n  4\\) HIV positive patients and\u002For HBV or HCV active infection (documented by HBV-DNA and HCV-RNA positive test) 5) Patients suffering from chronic respiratory diseases that require continuous oxygen inhalation, or a history of obvious renal, nervous system, psychiatric, endocrine, metabolic, immune, liver, and cardiovascular diseases 6) Patients suffering from malabsorption syndrome or other conditions that exclude enteral route of administration.\n\n  7\\) Patients has clinically significant QTc prolongation (\\>450 ms in men; \\>470 ms in women), ventricular tachycardia and atrial fibrillation, second-degree heart block, myocardial infarction within the year prior to enrollment, and congestive heart failure;and patients with coronary heart disease with clinical symptoms requiring drug treatment.\n\n  8\\) Active, uncontrolled severe infection. 9) History of other malignancies within 2 years, except for the following: Adequately treated cervix or breast cancer in situ; Basal cell cancer or local squamous cell carcinoma of the skin; 10) White blood cell count \\> 25 × 10\\^9\u002FL. (Hydroxyurea or leukapheresis may meet this criterion.) 11) Mental disorders that hinder research participation 12) Participants have received the following treatments: hypomethylating agents, veneclax and\u002For chemotherapy for myelodysplastic syndrome (MDS), solid organ transplantation.\n\n  13\\) Any other circumstances that the investigator believes that the patient is not suitable to participate in this trial",{"count":533,"type":21},66,[24],"The purpose of this study is to evaluate the safety and efficacy of Venetoclax Combining Chidamide and Azacitidine (VCA) Followed by D-MAG Regimen on the Treatment of Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)",[27,537],"AML Stage, Adult",[539,540,541],"newly diagnosed acute myeloid leukemia","liposome mitoxantrone","sequential treatment","2025-02-18",{"date":544,"type":57},"2025-02-19",{"date":546,"type":57},"2022-12-01",{"date":548,"type":21},"2026-12-31",{"name":399,"class":157},{"id":551,"slug":552,"hasResults":12,"nctId":553,"briefTitle":554,"officialTitle":555,"acronym":4,"eligibilityCriteria":556,"healthyVolunteers":12,"sex":557,"minAge":18,"maxAge":4,"enrollmentInfo":558,"targetDuration":4,"studyType":22,"phases":560,"briefSummary":561,"conditions":562,"keywords":565,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":572,"lastUpdatePostDateStruct":573,"startDateStruct":575,"completionDateStruct":577,"leadSponsor":579,"locationsCount":132},"100576421","genetic-landscape-in-women-with-metastatic-ovarian-cancer-before-and-during-treatment-with-parp-inhibitors-100576421","NCT06785077","Genetic Landscape in Women with Metastatic Ovarian Cancer Before and During Treatment with PARP Inhibitors","Mutational Landscape of Women Suffering from Metastatic Ovarian Cancer Before Poly (ADP-ribose) Polymerase Inhibitors Maintenance Treatment and During Treatment. Incidence of Therapy-related Hematological Neoplasms.","Inclusion Criteria:\n\nWomen with advanced ovarian cancer in complete or partial remission after surgery and eligible to oral PARP inhibitors as first line in association to chemotherapy or as maintenance therapy.\n\nExclusion Criteria:\n\n* Presence of blood cell count abnormalities before PARP inhibitor treatment;\n* Bone marrow infiltration by EOC cells.","FEMALE",{"count":559,"type":21},157,[142],"Therapy related acute myeloid leukemia and myelodysplasia (t-MN) is a potential late complication of cytotoxic therapy, and it is of particular concern in the treatment of patients with epithelial ovarian carcinoma (EOC) exposed to multiple cycles of platinum-based chemotherapy during the course of their disease. An epidemiological analysis published in 2011 (Gynecologic Oncology) showed that the overall incidence of t-AML is 0.17%, with a median latency to development of leukemia of 4 years (range 0-27 years).\n\nInhibition of PARP is a potential synthetic lethal therapeutic strategy for the treatment of cancers characterized by specific DNA repair defects, such as those that harbor a BRCA1 or BRCA2 (BRCA1\u002F2) mutation and are therefore deficient in homologous recombination repair. In homologous recombination-deficient tumors, PARP inhibition eliminates an alternative DNA repair pathway essential for maintaining viability, leading to tumor cell death. The estimated prevalence of BRCA1\u002F2 mutations in V2 03\u002F06\u002F2021 2 patients with newly diagnosed high-grade serous ovarian cancer is 20-25% and it might be higher in patients with platinum-sensitive, relapsed ovarian cancer. Early studies have shown significant efficacy for PARP inhibitors in patients with germline BRCA1\u002F2 mutations.\n\nOur hypothesis is that these patients are carriers of clonal hematopoiesis of indeterminate potential (CHIP) before treatment with PARPi. CHIP refers to the presence of clonal population(s) of hematopoietic cells with somatic mutations in genes associated with hematological malignancies (e.g. DNMT3A, ASXL1, TET2, TP53 and others), in the absence of morphological evidence of disease.\n\nThe proposed study will address the hypothesis that platinum-based chemotherapy may promote the onset of newly developed mutated clones and clonal selection of hematopoietic stem cells harboring somatic mutations.\n\nMoreover, the concomitant presence of germline mutations in cancer predisposing genes might increase the pool of pre-existing hematopoietic clones and\u002For favor the accumulation of subsequent somatic mutations.\n\nIn this context, the inhibition of PARP-mediated repair of DNA lesions created by chemo or radiotherapy can further favor t-MN development.",[27,563,564],"Myeloid Dysplasia","Ovarian Epithelial Cancer",[566,567,568,569,570,571],"PARP inhibitors (PARPi) Treatment","gene panels","clonal hematopoiesis of indeterminate potential (CHIP)","Analysis on peripheral blood","Analysis on bone marrow","Genetic analysis","2025-01-17",{"date":574,"type":57},"2025-01-20",{"date":576,"type":57},"2020-10-02",{"date":578,"type":21},"2028-04-30",{"name":580,"class":157},"European Institute of Oncology",{"id":582,"slug":583,"hasResults":12,"nctId":584,"briefTitle":585,"officialTitle":586,"acronym":4,"eligibilityCriteria":587,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":507,"enrollmentInfo":588,"targetDuration":4,"studyType":22,"phases":590,"briefSummary":591,"conditions":592,"keywords":593,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":599,"lastUpdatePostDateStruct":600,"startDateStruct":602,"completionDateStruct":604,"leadSponsor":606,"locationsCount":132},"100565575","venetoclax-combined-with-intensive-therapy-for-acute-myeloid-leukemia-patients-with-lower-early-peripheral-blast-clearance-rate-after-standard-induction-therapy-100565575","NCT06643962","Venetoclax Combined with Intensive Therapy for Acute Myeloid Leukemia Patients with Lower Early Peripheral Blast Clearance Rate After Standard Induction Therapy","A Single-Center Prospective Cohort Study to Evaluate the Efficacy and Safety of Intensifying Treatment with Venetoclax in Patients with Newly Diagnosed Acute Myeloid Leukemia (non-APL) and Exhibiting Lower Early Peripheral Blast Clearance Rate After Standard Intensive Induction Chemotherapy","Inclusion Criteria:\n\n* Newly diagnosed AML, except for the APL subtype, according to the 2022 World Health Organization classification (WHO 2022 criteria)\n* Age ≥18 years and ≤70 years\n* Eligible for intensive chemotherapy\n* No prior chemotherapy for AML except hydroxyurea for up to 14 days during the diagnostic screening phase for the control of peripheral leukemic blasts in patients with leukocytosis (e.g., white blood cell \\[WBC\\] counts\\>25x10\\^9\u002FL)\n* Eastern Cooperative Oncology Group (ECOG) performance status≤2\n* Adequate renal function is defined as:\n\n  * Serum creatinine≤2.0×upper limit of normal (ULN)\n  * Creatinine clearance (CrCl)\\>30 mL\u002Fmin calculated by the Cockcroft-Gault equation.\n* Adequate hepatic and heart function is defined as:\n\n  * Serum total bilirubin≤1.5×ULN unless considered due to Gilbert's disease, or leukemic involvement\n  * Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP)≤2.5×ULN, unless considered due to leukemic involvement\n  * Myocardial enzyme\\\u003C2.0×ULN\n  * Left ventricular ejection fraction is within the normal range by measure of echocardiogram (ECHO)\n* Signed a written informed consent form (ICF)\n* Female participants who are of non-reproductive potential (i.e., post-menopausal by history of no menses for ≥1 year; OR history of hysterectomy; OR history of bilateral tubal ligation; OR history of bilateral oophorectomy). Female participants of childbearing potential must have a negative serum pregnancy test upon study entry\n\nExclusion Criteria:\n\n* AML with BCR-ABL1 or myeloid blast crisis of CML\n* Participants who have received prior treatment for AML with chemotherapy, hypomethylating agents, or venetoclax\n* Participants who are ineligible for intensive induction chemotherapy:\n\n  * ≧71 years old OR\n  * ≧18 to 70 years old and fulfill at least one criterion associated with lack of fitness for intensive induction chemotherapy:\n\n    * ECOG PS of 2-3\n    * Cardiac history of CHF requiring treatment or Ejection Fraction ≦50% or chronic stable angina\n    * Diffusing capacity of the lungs for carbon monoxide (DLCO)≦65% or the forced expiratory volume in one second (FEVI) ≦65%\n* Participants with a prior history of MDS, MPN, or MDS\u002FMPN\n* Participants with other concurrent malignant tumors on treatment, except for:\n\n  * Malignancy treated with curative intent and with no known active disease present for ≧3 years\n  * Adequately treated non-melanoma skin cancer or lentigo maligna without current evidence of disease\n  * Adequately treated carcinoma in situ without current evidence of disease\n  * Localized prostate cancer with a Gleason score of 6 or less\n* Pregnant or lactating women\n* Active heart disease is defined as any one of the following:\n\n  * Uncontrolled or symptomatic angina pectoris\n  * A myocardial infarction six months before enrolled\n  * Arrhythmia needs medication or with severe clinical symptoms\n  * Uncontrolled or symptomatic congestive heart failure (New York Hear Association \\[NYHA\\] classification\\> grade 2)\n* Participants with an active, uncontrolled, systemic fungal, bacterial, or viral infection without improvement despite appropriate antibiotics, antiviral therapy, and\u002For other treatment\n* Participants with an active viral infection caused by HIV, hepatitis B, or hepatitis C virus that cannot be controlled by treatment\n* Participants with evidence of central nervous system leukemia before the study treatment\n* Participants with epilepsy which needs drug treatment, dementia, or other abnormal mental states that prevent understanding or following the protocol\n* Conditions that restrict the intake or absorption of orally administered drugs",{"count":589,"type":21},83,[142],"This single-center prospective cohort study aims to evaluate the efficacy and safety of Intensifying treatment with Venetoclax along with intensive chemotherapy in patients with newly diagnosed acute myeloid leukemia (AML) except acute promyelocytic leukemia (non-APL) and exhibiting lower early peripheral blast clearance rate (EPBCR) after standard Intensive Induction therapy (3+7 regimen).",[48,177,27],[594,595,596,597,598],"acute myeloid leukemia","venetoclax","intensive chemotherapy","early peripheral blast clearance","newly diagnosed","2024-11-10",{"date":601,"type":57},"2024-11-12",{"date":603,"type":57},"2024-10-31",{"date":605,"type":21},"2027-10-31",{"name":607,"class":157},"Affiliated Hospital of Nantong University",{"id":609,"slug":610,"hasResults":12,"nctId":611,"briefTitle":612,"officialTitle":613,"acronym":4,"eligibilityCriteria":614,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":507,"enrollmentInfo":615,"targetDuration":4,"studyType":22,"phases":616,"briefSummary":618,"conditions":619,"keywords":621,"overallStatus":148,"whyStopped":4,"lastUpdateSubmitDate":624,"lastUpdatePostDateStruct":625,"startDateStruct":627,"completionDateStruct":629,"leadSponsor":631,"locationsCount":132},"100559093","early-phase-1-hema-neotil01-cell-infusion-therapy-in-relapsedrefractory-acute-leukemia-100559093","NCT06559644","Hema-NeoTIL01 Cell Infusion Therapy in Relapsed\u002FRefractory Acute Leukemia","Assessment of the Safety and Efficacy of Hema-NeoTIL01 Cell Infusion Therapy in Relapsed\u002FRefractory Acute Leukemia: A Single-Arm, Open-Label, Prospective Study","Inclusion Criteria:\n\n1. Age ≥18 and \\\u003C70 years old, gender not specified;\n2. Diagnosed with B-ALL or AML according to the World Health Organization (WHO) classification of hematopoietic and lymphoid tissue tumors (2022 version);\n3. Meet the diagnosis of relapsed\u002Frefractory leukemia, excluding isolated extramedullary relapse; For relapsed or refractory ALL, including any of the following situations: a) Relapse: Peripheral blood or bone marrow recurrence of primitive cells \\>5% or extramedullary lesions appear again after complete remission; b) Refractory: Primary refractory patients who fail to achieve complete remission after standard induction chemotherapy; Or meet the diagnosis of relapsed or refractory AML, including any of the following situations: a) Relapse: Recurrence of primitive cells \\>5% in bone marrow after complete remission (except for reasons such as bone marrow regeneration after consolidation chemotherapy) or extramedullary infiltration of leukemia cells; b) Refractory: Patients who have failed two cycles of standard treatment; those who relapse within 12 months after CR after consolidation therapy; those who relapse after 12 months and are ineffective after conventional chemotherapy; those with two or more relapses; those with persistent extramedullary leukemia;\n4. Patients who have previously received ineffective\u002Frelapsed CAR-T cell therapy may be included in this study, provided that the efficacy evaluation of CAR-T therapy has been completed and evaluated as NR, or relapse after remission of CAR-T therapy;\n5. Estimated survival \\>12 weeks;\n6. Eastern Cooperative Oncology Group (ECOG) performance status score ≤2;\n7. Left ventricular ejection fraction (LVEF) ≥50%;\n8. Pulmonary function ≤Grade 1 dyspnea (CTCAE v5.0), normal oxygen saturation without oxygen supplementation;\n9. Total bilirubin (TBil) ≤3×upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤5×ULN, creatinine ≤1.6mg\u002FdL;\n10. Pregnancy test must be negative, and fertile non-abstinent female patients must agree to use effective contraception from the start of self-screening to 1 year after cell infusion. Fertile male patients with fertile partners must agree to use effective contraception from the start of self-screening to 1 year after cell infusion, and should not donate semen or sperm throughout the study period.\n11. The subject and their legal guardian voluntarily participate in this study, understand the trial information and objectives, and provide informed consent with a signed and dated signature.\n12. The subject and their legal guardian are willing and able to comply with all trial requirements.\n\nExclusion Criteria:\n\n1. Patients with a history of severe central nervous system diseases, such as uncontrolled seizures, stroke, severe brain injury resulting in aphasia, paralysis, dementia, Parkinson's disease, psychiatric disorders, etc.;\n2. New York Heart Association (NYHA) functional class III or IV heart failure;\n3. Any unstable diseases occurring within 6 months before screening (including but not limited to): unstable angina, ischemic or cerebrovascular accidents, myocardial infarction, severe arrhythmias requiring drug treatment (such as rapid atrial fibrillation, high-degree atrioventricular block, ventricular tachycardia, ventricular fibrillation, or torsades de pointes), cardiac catheterization or coronary artery stenting, or coronary artery bypass surgery, thrombotic or embolic events.\n4. Presence of disseminated intravascular coagulation;\n5. Severe autoimmune diseases or immunodeficiency diseases;\n6. Active graft-versus-host disease requiring continued systemic therapy;\n7. Subjects receiving systemic corticosteroids or other immunosuppressive therapy before screening, and the investigator determines that they will continue to use long-term therapy after enrollment (excluding inhalation or local use);\n8. History of or concomitant active malignant tumors, excluding cured non-invasive basal cell or squamous cell skin cancer, uterine cervical carcinoma in situ or localized prostate cancer or breast ductal carcinoma in situ without recurrence for at least 2 years;\n9. Presence of other severe medical conditions as determined by the investigator, such as uncontrolled hypertension or diabetes, severe renal insufficiency, severe pulmonary dysfunction, etc.;\n10. Active HBV or HCV infection (HBV-DNA positive or HCV-RNA positive), HIV positive, or syphilis positive;\n11. Other severe or persistent active infections;\n12. Severity of adverse events related to previous systemic immunotherapy (including other investigational drugs or medical device interventions) at screening not reduced to grade 1 or baseline status;\n13. Discontinuation of immunosuppressants within 2 weeks prior to screening;\n14. History of allergy to any component of the cell product;\n15. Vaccination or any surgical procedure within 4 weeks prior to screening;\n16. Other conditions deemed by the investigator to potentially increase subject risk or interfere with trial results.",{"count":333,"type":21},[617],"EARLY_PHASE1","This clinical trial aims to investigate the safety, optimal dosage, and effectiveness of autologous tumor-specific T cells, known as Hema-NeoTIL0 in treating relapsed\u002Frefractory B-ALL\u002FAML.",[27,620],"B-cell Acute Lymphoblastic Leukemia",[622,170,623],"B-ALL","T cell therapy","2024-08-14",{"date":626,"type":57},"2024-08-19",{"date":628,"type":21},"2024-09-01",{"date":630,"type":21},"2026-12-01",{"name":632,"class":157},"The First Affiliated Hospital of Soochow University",{"id":634,"slug":635,"hasResults":12,"nctId":636,"briefTitle":637,"officialTitle":638,"acronym":639,"eligibilityCriteria":640,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":641,"enrollmentInfo":642,"targetDuration":4,"studyType":22,"phases":644,"briefSummary":645,"conditions":646,"keywords":4,"overallStatus":148,"whyStopped":4,"lastUpdateSubmitDate":647,"lastUpdatePostDateStruct":648,"startDateStruct":650,"completionDateStruct":652,"leadSponsor":654,"locationsCount":4},"100487556","phase-2-testing-the-use-of-combination-therapy-in-patients-with-persistent-low-level-acute-myeloid-leukemia-aml-following-initial-treatment-100487556","NCT05628623","Testing the Use of Combination Therapy in Patients With Persistent Low Level Acute Myeloid Leukemia (AML) Following Initial Treatment","Eradicating Measurable Residual Disease in Patients With Acute Myeloid Leukemia (AML) Prior to StEm Cell Transplantation (ERASE): A MyeloMATCH Treatment Trial","ERASE","Inclusion Criteria:\n\n* Patient must be ≥ 18 and ≤ 59 years of age.\n* Patient must have ECOG performance status 0-2\n* Patient must have morphologically documented AML or secondary AML \\[from prior conditions such as myelodysplastic syndrome (MDS), myeloproliferative neoplasm (MPN)\\] or therapy related AML (t-AML), as defined by World Health Organization (WHO) criteria\n* Patient must have completed induction chemotherapy in a myeloMATCH Young Adult Tier-1 protocol. Patient may have received prior hypomethylating agents (HMAs). Patient may have received prior azacitidine + venetoclax.\n* Patient must have been assigned to this protocol by myeloMATCH MSRP\u002FMATCHBOX\u002F. Patients thereby assigned will have attained complete remission (CR) or CR with partial hematologic recovery (CRh) (defined as CR with (ANC) ≥ 500\u002FmcL and\u002For platelets \\> 50\u002FmcL) with detectable MRD at time of assignment. MRD is defined as \\>0.1% flow cytometry on bone marrow (BM) biopsy as assessed by MDNet. The definition of CR or CRh may be made ± 2 weeks from BM biopsy\n* Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and\u002For family member available will also be considered eligible.\n* Patient must have recovered (i.e.: resolved to \\\u003C grade 2) from adverse events related to prior anti-cancer therapy at the time of randomization with the exception of alopecia\n* Patient must have adequate organ and marrow function as defined below (these labs must be obtained ≤ 7 days prior to protocol randomization):\n\nAbsolute neutrophil count (ANC) ≥ 500\u002FmcL ANC:\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_ Date of Test:\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_ Platelets ≥ 50,000\u002FmcL Platelets:\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_ Date of Test:\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_ Total bilirubin ≤ 2 x institutional upper limit of normal (ULN) Total Bilirubin:\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_ Institutional ULN:\\_\\_\\_\\_\\_\\_\\_\\_\\_ Date of Test:\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_ AST(SGOT)\u002FALT(SGPT) ≤ 3.0 × institutional ULN AST:\\_\\_\\_\\_\\_\\_\\_ Institutional ULN:\\_\\_\\_\\_\\_\\_\\_\\_\\_ Date of Test:\\_\\_\\_\\_\\_\\_\\_ ALT: \\_\\_\\_\\_\\_\\_\\_Institutional ULN:\\_\\_\\_\\_\\_\\_\\_\\_\\_ Creatinine ≤ 1.5 x institutional ULN Creatinine \\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_Date of Test:\\_\\_\\_\\_\\_\\_\\_\\_ OR\n\n≥ 50 mL\u002Fmin\u002F1.73 m2\n\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization are eligible for this trial.\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n* Patients with a history of hepatitis C virus (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* 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* Patients must be able to swallow oral tablets and be free of GI absorption issues.\n\nExclusion Criteria:\n\n* Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used.\n\nAll patients of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy.\n\nA patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).\n\nPatient of child bearing potential? \\_\\_\\_\\_\\_\\_ (Yes or No) Date of blood test or urine study: \\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\n\n* Patients of childbearing potential and\u002For sexually active patients must not expect to conceive or father children by using an accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study and continue for 6 months after the last dose of daunorubicin + cytrarabine liposome, 6 months after the last dose of azacitidine for patients of childbearing potential, 3 months after the last dose of azacitidine for male patients, and for 30 days after the last dose of venetoclax. Patient must also abstain from nursing an infant for 2 weeks after the last dose of daunorubicin + cytrarabine liposome and for 1 week after the last dose of azacitidine.\n* Patients must not have FLT3 TKD or ITD mutation. Patients with this mutation, will be excluded from this study because myeloMATCH plans separate studies in tier-2 for those patients\n* Patient must not be receiving any other investigational agents at the time of randomization.\n* Patient must not have history of allergic reactions attributed to compounds of similar chemical or biologic composition to cytarabine, azacitidine, venetoclax or Daunorubicin and Cytarabine liposome\n* Patients must not have uncontrolled intercurrent illness including but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or serious chronic gastrointestinal conditions associated with diarrhea","59 Years",{"count":643,"type":21},184,[24],"ERASE is part of the MyeloMATCH initiative, Young Adult Basket and is a Tier 2 study. The study is comparing the use of Cytarabine to Cytarabine and Venetoclax, Daunorubicin\u002FCytarabine Liposome and Venetoclax, and Azacitidine and Venetoclax.",[27],"2024-06-29",{"date":649,"type":57},"2024-07-03",{"date":651,"type":21},"2024-10-23",{"date":653,"type":21},"2027-02",{"name":655,"class":656},"Eastern Cooperative Oncology Group","NETWORK",{"id":658,"slug":659,"hasResults":12,"nctId":660,"briefTitle":661,"officialTitle":662,"acronym":4,"eligibilityCriteria":663,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":664,"enrollmentInfo":665,"targetDuration":4,"studyType":22,"phases":667,"briefSummary":668,"conditions":669,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":670,"lastUpdatePostDateStruct":671,"startDateStruct":673,"completionDateStruct":675,"leadSponsor":676,"locationsCount":132},"100491717","phase-1-chidamide-prevents-recurrence-of-high-risk-aml-after-allo-hsct-100491717","NCT05682755","Chidamide Prevents Recurrence of High-risk AML After Allo-HSCT","Chidamide Prevents the Recurrence of High-risk Acute Myeloid Leukemia After Allogeneic Hematopoietic Stem-cell Transplantation: A Prospective, Single-centered, Single-arm, Phase I\u002FII Clinical Study","Inclusion Criteria:\n\n1. Age ≥ 18 years old and ≤ 65 years old when signing the Informed Consent Form (ICF);\n2. KPS score \\> 60 or ECOG score 0-2;\n3. The expected survival period \\> 3 months;\n4. Received allo-HSCT and achieved complete remission (CR);\n5. Reach the standard of hematopoietic reconstitution (neutrophil count ≥ 0.5×10\\^9\u002FL for 3 consecutive days without G-CSF application, platelet count ≥ 20×10\\^9\u002FL for 7 consecutive days without platelet transfusion, Hb ≥ 80 g \u002FL without red blood cell transfusion); and neutrophil count ≥ 1.5×10\\^9\u002FL, platelet count ≥ 50×10\\^9\u002FL within 45 days after transplantation;\n6. No central nervous system involvement or clinical symptoms after transplantation;\n7. Those who have no serious functional damage to important organs of the body;\n8. Fully understand and be informed of this study and sign the ICF; willing to follow and have the ability to complete all test procedures;\n9. Females of childbearing age must afford a serum pregnancy test within 7 days before the first dose, and the result should be negative; female participants and their partners should agree to use effective contraception from signing the ICF until 6 months after the last dose.\n\nExclusion Criteria:\n\n1. Serious basic diseases of important organs: such as myocardial infarction, chronic cardiac insufficiency, decompensated hepatic insufficiency, renal function, gastrointestinal insufficiency, etc.;\n2. Uncontrolled active infection (including bacterial, fungal, or viral infection), and drug treatment is ineffective;\n3. Participating in other clinical studies, or planning to start treatment in this study and less than 4 weeks before the end of treatment in the previous clinical study;\n4. Poor graft function (PGF) occurred after allo-HSCT;\n5. Combined with other malignant tumors and require treatment;\n6. Active GVHD;\n7. Have a history of allergy to Chidamide;\n8. Pregnant or lactating females;\n9. Patients with known history of human immunodeficiency virus (HIV) virus infection and\u002For acquired immunodeficiency syndrome;\n10. Patients with active chronic hepatitis B or active hepatitis C;\n11. History of prolonged QT syndrome;\n12. Patients considered by other researchers to be unsuitable for this study.","65 Years",{"count":666,"type":21},77,[100,24],"The goal of this phase I\u002FII clinical trial is to test in high-risk acute myeloid leukemia (AML) patients undergoing allogeneic hemopoietic stem-cell transplantation (allo-HSCT). The main question it aims to answer is:\n\n• The efficacy and safety of chidamide maintenance therapy in reducing the recurrence rate and GVHD incidence in high-risk AML patients after allo-HSCT.\n\nParticipants will take oral chidamide (Epidaza) until 180 days after allo-HSCT.",[27],"2022-12-27",{"date":672,"type":57},"2023-01-12",{"date":674,"type":57},"2022-12-22",{"date":548,"type":21},{"name":677,"class":157},"Sichuan University"]