[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"secondary-acute-myeloid-leukemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:secondary-acute-myeloid-leukemia":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,44,94,122,154,179,200,227,255],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100507335","phase-1-a-phase-1b-study-of-menin-inhibitor-sndx--5613-in-combination-with-daunorubicin-and-cytarabine-in-newly-diagnosed-patients-with-acute-myeloid-leukemia-and-npm1-mutatedflt3-wildtype-or-mllkmt2a-rearranged-or-nup98-alterations-disease-100507335",false,"NCT05886049","A Phase 1b Study of Menin Inhibitor SNDX- 5613 in Combination With Daunorubicin and Cytarabine in Newly Diagnosed Patients With Acute Myeloid Leukemia and NPM1 Mutated\u002FFLT3 Wildtype or MLL\u002FKMT2A Rearranged or NUP98 Alterations Disease","A Phase 1b Study of Menin Inhibitor SNDX-5613 in Combination With Daunorubicin and Cytarabine in Newly Diagnosed Patients With Acute Myeloid Leukemia and NPM1 Mutated\u002FFLT3 Wildtype or MLL\u002FKMT2A Rearranged or NUP98 Alterations Disease","Inclusion Criteria:\n\n* Dose escalation: Patients ages 18-75 years at time of diagnosis with NPM1-mutated\u002FFLT3-ITD wildtype and NPM1-mutated\u002FFLT3-TKD wildtype with high-risk features (adverse risk genetics per European LeukemiaNet \\[ELN\\] 2022 criteria, age ≥ 60 years, or secondary AML defined as either arising from a prior hematological malignancy or therapy-related), MLL (KMT2A) rearranged or NUP98 altered, untreated AML and who are candidates for intensive induction chemotherapy. Patients with CD33+ AML are eligible for this protocol.\n* Dose expansion: Patients ages 18-75 years at time of diagnosis with NPM1-mutated\u002FFLT3-ITD wildtype and NPM1-mutated\u002FFLT3-TKD wildtype (any patient-does not require high-risk features), MLL (KMT2A) rearranged, or NUP98 altered, untreated AML and who are candidates for intensive induction chemotherapy. Patients with CD33+ AML are eligible for this protocol\n* Because no dosing or adverse event data are currently available on the use of SNDX-5613 in combination with daunorubicin and cytarabine in patients \\\u003C 18 years of age, children are excluded from this study\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 2 (Karnofsky \\>= 60%). Patients over the age of 65 must have an ECOG performance status of 0-1\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN), except for patients with Gilbert's syndrome where required to be ≤ 3 x institutional ULN\n* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT)(serum glutamic pyruvate transaminase \\[SGPT\\]) =\\\u003C 3 x institutional upper limit of normal (ULN)\n* Glomerular filtration rate (GFR) \\>= 60 mL\u002Fmin\u002F1.73 m\\^2 (via the Chronic Kidney Disease Epidemiology \\[CKD-EPI\\] glomerular filtration rate estimation)\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months 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 with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better\n* Ejection fraction \\>= 50% (or \\>= 45% if no evidence of congestive heart failure \\[CHF\\] or other cardiac symptoms) by transthoracic echocardiogram (TTE) or multi-gated acquisition (MUGA) scan\n* White blood cells (WBC) must be \\\u003C 25 x 10\\^9\u002FL. Hydroxyurea and leukapheresis are permitted to control the WBC prior to enrollment and initiation of protocol-defined therapy but must be stopped within 24 hours of initiation of protocol therapy. Must not have had any signs of leukostasis requiring cytoreduction\n* Female patients of childbearing potential must agree to use 2 forms of contraception from screening visit until 120 days following the last dose of study treatment. Male patients of childbearing potential having intercourse with females of childbearing potential must agree to abstain from heterosexual intercourse or have their partner use 2 forms of contraception from screening visit until 180 days until the last dose of study treatment. They must also refrain from sperm donation from screening visit until 180 days following the last dose of study treatment\n* Patients must have previously untreated AML with no prior treatment other than hydroxyurea or intrathecal chemotherapy for central nervous system (CNS) prophylaxis\u002Ftreatment. No chemotherapy for AML outside of hydroxyurea for treatment of leukostasis or all-trans retinoic acid (ATRA) for initially suspected acute promyelocytic leukemia (APL) (that is ruled out) is allowed\n* Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants\n\nExclusion Criteria:\n\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to SNDX-5613, daunorubicin or cytarabine\n* Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous\n* Patient must not have received known strong or moderate CYP3A4 inhibitors, or strong CYP3A4 inducers (with the exception of antifungal prophylaxis with azoles) within 7 days of enrollment. As part of the enrollment\u002Finformed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product\n* Pregnant women are excluded from this study because SNDX-5613 is a menin-KMT2A inhibitor agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with SNDX-5613, breastfeeding should be discontinued if the mother is treated with SNDX-5613. These potential risks may also apply to other agents used in this study\n* Isolated myeloid sarcoma (i.e., patients must have blood or marrow involvement with AML to enter the study)\n* Acute promyelocytic leukemia (French-American-British \\[FAB\\] M3)\n* Untreated, active central nervous system (CNS) involvement by AML. Patients are allowed to undergoing diagnostic lumbar puncture (LP) with intrathecal chemotherapy while on study\n* Uncontrolled symptomatic disseminated intravascular coagulopathy with active bleeding or signs of thrombosis\n* Patients with Fridericia's correction formula (QTcF) \\>= 450 ms at screening; patients with right, left, or partial bundle branch blocks or a pacemaker who are asymptomatic are eligible regardless of QTC if cleared by cardiology for enrollment in the trial. Any factors that increase the risk of QTc prolongation or risk of arrhythmic event such as congenital long QT syndrome or family history of long QT syndrome\n* Patients who will exceed a lifetime anthracycline exposure of \\> 550 mg\u002Fm\\^2 daunorubicin or equivalent (or \\> 400 mg\u002Fm\\^2 daunorubicin or equivalent in the event of prior mediastinal radiation) if they receive the maximum potential exposure to anthracyclines per protocol (including both induction and reinduction cycles)\n* Patients with any gastrointestinal issue of the upper gastrointestinal (GI) tract that might affect oral drug absorption or ingestion (eg, gastric bypass, gastroparesis, etc)\n* Patients who have cirrhosis with a Child-Pugh score of B or C\n* Patients with Down Syndrome due to higher rates of chemotherapy-associated toxicities, and may have different pharmacokinetics, as well. Toxicities that occur at higher frequencies include cardiotoxicity, a known risk of SNDX-5613 treatment (i.e., QTcF prolongation)\n* Patients with myelodysplastic syndromes (MDS) treated with previous intensive induction regimens similar to 7+3","ALL","18 Years","75 Years",{"count":20,"type":21},38,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This phase Ib trial tests the safety, side effects, and best dose of SNDX-5613 when given in combination with the standard chemotherapy treatment (daunorubicin and cytarabine) in treating patients with newly diagnosed acute myeloid leukemia that has changes in the NPM1 gene or MLL\u002FKMT2A gene. SNDX-5613 blocks signals passed from one molecule to another inside cancer cells that are needed for cancer cell survival. Drugs used in chemotherapy, such as daunorubicin and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Adding SNDX-5613 to the standard chemotherapy treatment may be able to shrink or stabilize the cancer for longer than the standard chemotherapy treatment alone.",[27,28,29,30],"Acute Myeloid Leukemia","Acute Myeloid Leukemia With KMT2A Rearrangement","Acute Myeloid Leukemia With NPM1 Mutation","Secondary Acute Myeloid Leukemia","RECRUITING","2026-06-16",{"date":34,"type":35},"2026-06-17","ACTUAL",{"date":37,"type":35},"2024-06-20",{"date":39,"type":21},"2027-12-31",{"name":41,"class":42},"National Cancer Institute (NCI)","NIH",22,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":93},"100264904","phase-2-personalized-nk-cell-therapy-in-cbt-100264904","NCT02727803","Personalized NK Cell Therapy in CBT","Inclusion Criteria:\n\n* Patients must have one of the following hematologic malignancies: acute myelogenous leukemia (AML), induction failure, high-risk for relapse first remission (with intermediate-risk or high-risk cytogenetics including complex karyotype, abnormal \\[abn\\]\\[3q\\], -5\u002F5q-, -7\u002F7q-, abn\\[12p\\], abn\\[17p\\], myeloid\u002Flymphoid or mixed-lineage leukemia \\[MLL\\] gene re-arrangement and t \\[6;9\\]47, fms related tyrosine kinase 3 \\[flt3\\] mutation positive and\u002For evidence of minimal residual disease by flow cytometry), secondary leukemia from prior chemotherapy and\u002For arising from myelodysplastic syndromes (MDS), any disease beyond first remission\n* Myelodysplastic syndrome (MDS): Primary or therapy related, including patients that will be considered for transplant; these include any of the following categories: 1) revised International Prognostic Scoring System (IPSS) intermediate and high risk groups, 2) malondialdehyde (MDA) with transfusion dependency, 3) failure to respond or progression of disease on hypomethylating agents, 4) refractory anemia with excess of blasts, 5) transformation to acute leukemia, 6) chronic myelomonocytic leukemia, 7) atypical MDS\u002Fmyeloproliferative syndromes, 8) complex karyotype, abn(3g), -5\u002F5g-, -7\u002F7g-, abn(12p), abn(17p)\n* Acute lymphoblastic leukemia (ALL): Induction failure, primary refractory to treatment (do not achieve complete remission after first course of therapy) or are beyond first remission including second or greater remission or active disease; patients in first remission are eligible if they are considered high risk, defined as any of the following detected at any time: with translocations 9;22 or 4;11, hypodiploidy, complex karyotype, secondary leukemia developing after cytotoxic drug exposure, and\u002For evidence of minimal residual disease or acute biphenotypic leukemia, or double hit non-Hodgkin's lymphoma\n* Non-Hodgkin's lymphoma (NHL) in second or third complete remission, or relapse (including relapse post autologous hematopoietic stem cell transplant); relapsed double hit lymphomas; patients with options for treatment that are known to be curative are not eligible\n* Small lymphocytic lymphoma (SLL), or chronic lymphocytic leukemia (CLL) with progressive disease following a minimum of two lines of standard therapy\n* Chronic myeloid leukemia (CML) second chronic phase or accelerated phase\n* Hodgkin's disease (HD): Induction failures, after first complete remission, or relapse (including relapse post autologous hematopoietic stem cell transplant), or those with active disease\n* Multiple myeloma: stage II or III, symptomatic, secretory multiple myeloma requiring treatment\n* A person (such as a haploidentical family member) or unit of cord blood must be identified as a source of back-up cells source in case of engraftment failure\n* Patient age criteria: age \\>= 15 and =\\\u003C 45 years (myeloablative regimen 1; age \\>= 15 and =\\\u003C 80 years (nonmyeloablative regimen 2) at the discretion of the investigator(s); age \\>= 15 and =\\\u003C 80 years old that in the opinion of the investigator(s) would preclude myeloablative therapy may receive reduced intensity regimen 3\n* Performance score of at least 60% by Karnofsky\n* Left ventricular ejection fraction of at least 40% (myeloablative regimen 1, reduced intensity regimen 3)\n* Left ventricular ejection fraction of at least 30% (nonmyeloablative regimen 2)\n* Pulmonary function test (PFT) demonstrating an adjusted diffusion capacity of least 50% predicted value for hemoglobin concentration (myeloablative regimen 1, reduced intensity regimen 3)\n* Serum creatinine within normal range, or if serum creatinine outside normal range, then renal function (measured or estimated creatinine clearance or glomerular filtration rate \\[GFR\\]) \\> 40mL\u002Fmin\u002F1.73 m\\^2\n* Serum glutamate pyruvate transaminase (SGPT)\u002Fbilirubin \\\u003C to 2.0 x normal (myeloablative regimen 1), reduced intensity regimen 3; SGPT\u002Fbilirubin \\\u003C to 4.0 x normal (nonmyeloablative regimen 2)\n* Negative beta human chorionic gonadotropin (HCG) test in a woman with child bearing potential defined as not post-menopausal for 12 months\n* Patients with options for treatment that are known to be curative are not eligible\n* Patients enrolled in this study may be enrolled on other supportive care investigational new drug (IND) studies at the discretion of the principal investigator (PI)\n\nExclusion Criteria:\n\n* Human immunodeficiency virus (HIV) positive; HIV results will be determined by nucleic acid testing\n* Uncontrolled serious medical condition such as persistent septicemia despite adequate antibiotic therapy, decompensated congestive heart failure despite cardiac medications or pulmonary insufficiency requiring intubation (excluding primary disease for which cord blood \\[CB\\] transplantation is proposed), or psychiatric condition that would limit informed consent\n* Active central nervous system (CNS) disease in patient with history of CNS malignancy\n* Availability of appropriate, willing, human leukocyte antigen (HLA)-matched related stem cell donor","15 Years","80 Years",{"count":53,"type":21},100,[55],"PHASE2","This phase II clinical trial studies how well personalized natural killer (NK) cell therapy works after chemotherapy and umbilical cord blood transplant in treating patients with myelodysplastic syndrome, leukemia, lymphoma or multiple myeloma. This clinical trial will test cord blood (CB) selection for human leukocyte antigen (HLA)-C1\u002Fx recipients based on HLA-killer-cell immunoglobulin-like receptor (KIR) typing, and adoptive therapy with CB-derived NK cells for HLA-C2\u002FC2 patients. Natural killer cells may kill tumor cells that remain in the body after chemotherapy treatment and lessen the risk of graft versus host disease after cord blood transplant.",[58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,30,82],"Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive","Acute Biphenotypic Leukemia","Acute Lymphoblastic Leukemia","Acute Lymphoblastic Leukemia in Remission","Acute Myeloid Leukemia With Myelodysplasia-Related Changes","Acute Myeloid Leukemia With Variant MLL Translocations","B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1","Chemotherapy-Related Leukemia","Chronic Myelomonocytic Leukemia","Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive","High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements","ISS Stage II Plasma Cell Myeloma","ISS Stage III Plasma Cell Myeloma","Myelodysplastic Syndrome","Myelodysplastic Syndrome With Excess Blasts","Myelodysplastic Syndrome With Gene Mutation","Myelodysplastic\u002FMyeloproliferative Neoplasm","Previously Treated Myelodysplastic Syndrome","Recurrent Acute Myeloid Leukemia","Recurrent Adult Acute Myeloid Leukemia","Recurrent Hodgkin Lymphoma","Recurrent Non-Hodgkin Lymphoma","Refractory Acute Lymphoblastic Leukemia","Refractory Adult Acute Lymphoblastic Leukemia","Therapy-Related Myelodysplastic Syndrome","2026-05-20",{"date":85,"type":35},"2026-05-22",{"date":87,"type":35},"2016-05-19",{"date":89,"type":21},"2027-05-31",{"name":91,"class":92},"M.D. Anderson Cancer Center","OTHER",1,{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":101,"enrollmentInfo":102,"targetDuration":4,"studyType":22,"phases":104,"briefSummary":105,"conditions":106,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":93},"100218005","phase-2-cladribine-idarubicin-cytarabine-and-venetoclax-in-treating-patients-with-acute-myeloid-leukemia-high-risk-myelodysplastic-syndrome-or-blastic-phase-chronic-myeloid-leukemia-100218005","NCT02115295","Cladribine, Idarubicin, Cytarabine, and Venetoclax in Treating Patients With Acute Myeloid Leukemia, High-Risk Myelodysplastic Syndrome, or Blastic Phase Chronic Myeloid Leukemia","Phase II Study of Cladribine Plus Idarubicin Plus Cytarabine (ARAC) in Patients With AML, HR MDS, or Myeloid Blast Phase of CML","Inclusion Criteria:\n\n1. Patients with a diagnosis of AML, Acute Biphenotypic Leukemia, or high risk MDS (\\>\u002F= 10% blasts or IPSS \\>\u002F= intermediate-2) will be eligible. Patients with CML in Myeloid Blast Phase are also eligible.\n2. For Frontline cohort (1 or 4): No prior potentially-curative therapy for leukemia. Prior therapy with hydroxyurea, hematopoietic growth factors, azacytidine, decitabine, ATRA, or a total dose of cytarabine up to 2g (for emergency use for stabilization) is allowed. Patients deemed able to receive venetoclax (ie. insurance clearance) will be assigned to Frontline cohort 4. Patients with secondary AMLwho have been treated for their antecedent myeloid neoplasm will be enrolled into the separate Secondary AML cohort.\n3. For Salvage cohort: Patients with previously treated, relapsed or refractory AML, Acute Biphenotypic Leukemia, or CML in Myeloid Blast Phase are eligible.\n4. Age \\\u003C\u002F= 65 years.\n5. Adequate organ function as defined below:\n\n   * liver function (bilirubin \\\u003C 2mg\u002FdL, AST and\u002For ALT \\\u003C3 x ULN - or \\\u003C5 x ULN if related to leukemic involvement)\n   * kidney function (creatinine \\\u003C 1.5 x ULN ).\n   * known cardiac ejection fraction of \\> or = 45% within the past 6 months\n6. ECOG performance status of ≤ 2.\n7. A negative urine pregnancy test is required within 1 week for all women of childbearing potential prior to enrolling on this trial.\n8. Patient must have the ability to understand the requirements of the study and signed informed consent. A signed informed consent by the patient is required prior to their enrollment on the protocol.\n\nExclusion Criteria:\n\n1. Pregnant women are excluded from this study because the agents used in this study have the potential for teratogenic or abortifacient effects. Because there is a potential risk for adverse events in nursing infants secondary to treatment of the mother with the chemotherapy agents, breastfeeding should also be avoided.\n2. Uncontrolled intercurrent illness including, but not limited to active uncontrolled infection, symptomatic congestive heart failure (NYHA Class III or IV), unstable angina pectoris, clinically significant cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n3. Patient with documented hypersensitivity to any of the components of the chemotherapy program.\n4. Men and women of childbearing potential who do not practice contraception. Women of childbearing potential and men must agree to use contraception prior to study entry and for the duration of study participation.","65 Years",{"count":103,"type":21},508,[55],"This phase II trial studies how well cladribine, idarubicin, cytarabine, and venetoclax work in patients with acute myeloid leukemia, high-risk myelodysplastic syndrome, or blastic phase chronic myeloid leukemia. Drugs used in chemotherapy, such as cladribine, idarubicin, cytarabine, and venetoclax, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.",[59,27,107,108,109,110,71,75,76,111,112,113,30,114],"Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive","Blasts 10 Percent or More of Bone Marrow Nucleated Cells","Blasts 10 Percent or More of Peripheral Blood White Cells","de Novo Myelodysplastic Syndrome","Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive","Refractory Acute Myeloid Leukemia","Refractory Chronic Myelogenous Leukemia, BCR-ABL1 Positive","Untreated Adult Acute Myeloid Leukemia","2026-05-18",{"date":83,"type":35},{"date":118,"type":35},"2014-05-19",{"date":120,"type":21},"2030-05-31",{"name":91,"class":92},{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":4,"eligibilityCriteria":128,"healthyVolunteers":129,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":130,"targetDuration":4,"studyType":22,"phases":132,"briefSummary":133,"conditions":134,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":93},"100587459","phase-1-chemotherapy-decitabine-in-combination-with-flag-ida-and-total-body-irradiation-followed-by-donor-stem-cell-transplant-for-the-treatment-of-adults-with-myeloid-malignancies-at-high-risk-of-relapse-100587459","NCT06928662","Chemotherapy (Decitabine in Combination With FLAG-Ida) and Total-Body Irradiation Followed by Donor Stem Cell Transplant for the Treatment of Adults With Myeloid Malignancies at High Risk of Relapse","Sequential Decitabine in Combination With FLAG-Ida Followed Immediately by Reduced-Intensity Conditioning (RIC) Allogeneic Hematopoietic Cell Transplantation (DEC-FLAG-Ida\u002FRIC) for Adults With Myeloid Malignancies at High Risk of Relapse: A Phase 1\u002F2 Study","Inclusion Criteria:\n\n* Age ≥ 18 years with an HCT-co-morbidity index (CI) ≤ 5 for patients over 60 years.\n* AML (2022 World Health Organization \\[WHO\\] criteria) that is either primary refractory (as defined by failure of 2 cycles of 7+3-like chemotherapy, 1 cycle of high-dose cytarabine-based chemotherapy, or at least 2 cycles of venetoclax in combination with other therapies) or is in untreated or unsuccessfully treated first or subsequent relapse. Patients in morphologic remission (i.e. \\\u003C 5% blasts in the bone marrow) but evidence of minimal residual disease (MRD) by multiparameter flow cytometry, cytogenetics\u002Ffluorescence in situ hybridization (FISH), or molecular means will be eligible for trial participation. Patients with relapsed or refractory acute leukemia of ambiguous lineage (acute undifferentiated leukemia or mixed phenotype acute leukemia) that is either primary refractory or is in untreated or unsuccessfully treated first or subsequent relapse are also eligible.\n* MDS and CMML: Subjects with previously treated MDS and CMML, defined as prior treatment with at least one hypomethylating agent (hypomethylating agent \\[HMA\\]; azacitidine, decitabine and\u002For decitabine-cedazuridine) whose disease progressed, relapsed, or was refractory to HMA treatment as follows: 1) patients who have failed at least 4 cycles of monotherapy with azacitidine, decitabine or decitabine-cedazuridine, 2) patients who received at least 2 cycles of HMA in combination with another therapeutic agent. Subjects with MDS and CMML who failed at least 1 cycle of induction chemotherapy will be also eligible. Patients with MDS or CMML who progress to secondary AML will be eligible if they received at least 4 cycles of HMA alone or 2 cycles of HMA in combination with another therapeutic agent.\n* Patients may have previously received hypomethylating agents or chemotherapy with a mitoxantrone, idarubicin- or cladribine\u002Ffludarabine-based regimen for MDS or AML. If the patient has received cladribine-cytarabine-filgrastim-mitoxantrone (CLAG-M) or FLAG-Ida before and has been sensitive to this regimen, defined as MRD negative complete remission (CR) immediately after receiving the treatment and which lasts ≥ 1 year, eligibility will be determined on a case-by-case basis by the study principal investigator (PI).\n* The use of hydroxyurea prior to initiation of study treatment is allowed. Patients with symptoms\u002Fsigns of hyperleukocytosis, white blood cells (WBC) \\> 100,000\u002FμL or with concern for other complications of high tumor burden of high tumor dynamics (e.g. disseminated intravascular coagulation) can be treated with leukapheresis or may receive up to 2 doses of cytarabine (up to 500 mg\u002Fm\\^2 per dose) prior to start of study treatment.\n* Karnofsky score ≥ 70; Eastern Cooperative Oncology Group (ECOG) 0-1.\n* Adequate cardiac function defined as absence of decompensated congestive heart failure and\u002For uncontrolled arrhythmia and left ventricular ejection fraction ≥ 45%.\n* Bilirubin ≤ 2.5 x Institutional Upper Limit of Normal unless elevation is thought to be due to hepatic infiltration by AML, Gilbert's syndrome, or hemolysis\n* Adequate pulmonary function defined as absence of oxygen (O2) requirements and either diffusion capacity of the lung for carbon monoxide (DLCO) corrected ≥ 70%mmHg or DLCO corrected 60-69%mmHg and partial pressure of oxygen (pO2) ≥ 70mmHg.\n* Creatinine clearance \\> 60 mL\u002Fmin.\n* Prior autologous HCT is permissible if relapse occurred \\> 6 months after HCT.\n* Prior TBI-containing allogeneic HCT up to 3 Gy is permissible if \\> 6 months after HCT.\n* A human leukocyte antigen (HLA)-matched sibling\u002Funrelated donor, mismatched unrelated donor or haploidentical donor for collection of stimulated peripheral blood stem cells must be identified and readily available.\n* Ability to understand and sign a written informed consent document (or legal representative).\n* SIBLING DONOR: Related to the patient and genotypically or phenotypically identical for HLA-A, B, C, DRB1 and DQB1. Phenotypic identity must be confirmed by high-resolution typing.\n* MATCHED UNRELATED DONOR: Matched for HLA-A, B, C, DRB1 and DQB1 by high resolution typing; OR mismatched for a single allele without antigen mismatching at HLA-A, B, or C as defined by high resolution typing but otherwise matched for HLA-A, B, C, DRB1 and DQB1 by high resolution typing.\n* MATCHED UNRELATED DONOR: Donors are excluded when preexisting immunoreactivity is identified that would jeopardize donor hematopoietic cell engraftment. The recommended procedure for patients with 10 of 10 HLA allele level (phenotypic) match is to obtain panel reactive antibody (PRA) screens to class I and class II antigens for all patients before HCT. If the PRA shows \\> 10% activity, then flow cytometric or B and T cell cytotoxic cross matches should be obtained. The donor should be excluded if any of the cytotoxic cross match assays are positive. For those patients with an HLA Class I allele mismatch, flow cytometric or B and T cell cytotoxic cross matches should be obtained regardless of the PRA results. A positive anti-donor cytotoxic crossmatch is an absolute donor exclusion.\n* MATCHED UNRELATED DONOR: Patient and donor pairs homozygous at a mismatched allele in the graft rejection vector are considered a two-allele mismatch, i.e., the patient is A\\*0101 and the donor is A\\*0102, and this type of mismatch is not allowed.\n* MISMATCHED UNRELATED DONOR: HLA-matching must be based on results of high resolution typing at HLA-A, -B, -C, -DRB1, and -DQ.\n* MISMATCHED UNRELATED DONOR: Mismatch for one HLA class I antigen with or without an additional mismatch for one HLA-class I allele but matched for HLA-DRB1 and HLA-DQ.\n* MISMATCHED UNRELATED DONOR: Mismatched for two HLA class I alleles but matched for HLA-DRB1 and HLA-DQ.\n* MISMATCHED UNRELATED DONOR: HLA class I HLA-A, -B, -C allele matched donors allowing for any one or two DRB1 and\u002For DQB1 antigen\u002Fallele mismatch.\n* MISMATCHED UNRELATED DONOR: If the patient is homozygous at the mismatch HLA class I locus or II locus, the donor must be heterozygous at that locus and one allele must match the patient (i.e., patient is homozygous A\\*01:01 and donor is heterozygous A\\*01:01, A\\*02:01). This mismatch will be considered a one-antigen mismatch for rejection only.\n* HAPLOIDENTICAL DONOR: Donors must be haploidentical relatives of the patients. Donor-recipient compatibility will be tested through HLA typing at high resolution for the HLA loci (-A, -B, -C, -DRB1, -DQB1). Donor and recipient should share at least 5\u002F10 HLA loci.\n* HAPLOIDENTICAL DONOR: Age ≥ 18 years.\n* HAPLOIDENTICAL DONOR: Weight ≥ 40 kg.\n* HAPLOIDENTICAL DONOR: Donor must meet the selection criteria as defined by the Foundation of the Accreditation of Cell Therapy (FACT) and will be screened per the American Association of Blood Banks (AABB) guidelines.\n* DONOR: In case of more available donors, selection criteria should include, in this order:\n\n  * For cytomegalovirus (CMV) seronegative recipients, a CMV seronegative donor\n  * Red Blood Cell compatibility\n\n    * Red blood cell (RBC) cross match compatible\n    * Minor ABO incompatibility\n    * Major ABO incompatibility\n* DONOR: Donors will undergo diagnostic evaluation (clinical, laboratory test and imaging) as indicated per institutional guidelines.\n\nExclusion Criteria:\n\n* Active central nervous system (CNS) disease.\n* Concomitant illness associated with a likely survival of \\\u003C 1 year.\n* Active systemic fungal, bacterial, viral, or other infection, unless disease is under treatment with antimicrobials and\u002For controlled or stable. Patients with fever thought to be likely secondary to myeloid malignancy are eligible.\n* Known hypersensitivity or contraindication to any study drug used in this trial.\n* Pregnancy or lactation.\n* Concurrent treatment with any other approved or investigational anti-leukemia agent.\n* HAPLOIDENTICAL DONOR: Since detection of anti-donor-specific antibodies (anti-DSA) is associated with higher graft rejection rate, patients will be screened for anti-DSA pre-transplant. Patient with DSA mean fluorescent intensity (MFI) \\\u003C 5000 after desensitization treatment, will be considered eligible to participate in the study.",true,{"count":131,"type":21},36,[24,55],"This phase I\u002FII trial studies the safety, side effects, and best dose of decitabine in combination with fludarabine, cytarabine, filgrastim, and idarubicin (FLAG-Ida) and total body irradiation (TBI) followed by a donor stem cell transplant in treating adult patients with cancers of blood-forming cells of the bone marrow (myeloid malignancies) that are at high risk of coming back after treatment (relapse). Cancers eligible for this trial are acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and chronic myelomonocytic leukemia (CMML). Decitabine is in a class of medications called hypomethylation agents. It works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow. The FLAG-Ida regimen consists of the following drugs: fludarabine, cytarabine, filgrastim, and idarubicin. These are chemotherapy drugs that work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Filgrastim is in a class of medications called colony-stimulating factors. It works by helping the body make more neutrophils, a type of white blood cell. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. TBI is radiation therapy to the entire body. Giving chemotherapy and TBI before a donor peripheral blood stem cell (PBSC) transplant helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. When the healthy stem cells from a donor are infused into a patient, they may help the patient's bone marrow make more healthy cells and platelets. Giving decitabine in combination with FLAG-Ida and TBI before donor PBSC transplant may work better than FLAG-Ida and TBI alone in treating adult patients with myeloid malignancies at high risk of relapse.",[27,135,136,76,137,138,139,140,112,141,142,143,144,30],"Acute Undifferentiated Leukemia","Mixed Phenotype Acute Leukemia","Recurrent Acute Undifferentiated Leukemia","Recurrent Chronic Myelomonocytic Leukemia","Recurrent Mixed Phenotype Acute Leukemia","Recurrent Myelodysplastic Syndrome","Refractory Acute Undifferentiated Leukemia","Refractory Chronic Myelomonocytic Leukemia","Refractory Mixed Phenotype Acute Leukemia","Refractory Myelodysplastic Syndrome","2026-05-13",{"date":147,"type":35},"2026-05-15",{"date":149,"type":35},"2025-09-23",{"date":151,"type":21},"2028-11-29",{"name":153,"class":92},"Fred Hutchinson Cancer Center",{"id":155,"slug":156,"hasResults":11,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":4,"eligibilityCriteria":160,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":161,"enrollmentInfo":162,"targetDuration":4,"studyType":22,"phases":164,"briefSummary":165,"conditions":166,"keywords":4,"overallStatus":170,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":4},"100481853","phase-2-testing-the-use-of-combination-therapy-in-patients-with-persistent-low-level-acute-myeloid-leukemia-following-initial-treatment-the-erase-study-a-myelomatch-treatment-trial-100481853","NCT05554419","Testing the Use of Combination Therapy in Patients With Persistent Low Level Acute Myeloid Leukemia Following Initial Treatment, The ERASE Study (A MyeloMATCH Treatment Trial)","Eradicating Measurable Residual Disease in Patients With Acute Myeloid Leukemia (AML) Prior to StEm Cell Transplantation (ERASE): A MyeloMATCH Treatment Trial","Inclusion Criteria:\n\n* Patient must be \\>= 18 and =\\\u003C 59 years of age\n* Patient must have Eastern Cooperative Oncology Group (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 master screening and reassessment protocol (MSRP)\u002FMATCHBOX. Patients thereby assigned will have attained complete remission (CR) or CR with partial hematologic recovery (CRh) (defined as CR with \\[absolute neutrophil count (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 +\u002F- 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* Absolute neutrophil count (ANC) \\>= 500\u002FmcL (obtained =\\\u003C 7 days prior to protocol randomization)\n* Platelets \\>= 50,000\u002FmcL (obtained =\\\u003C 7 days prior to protocol randomization)\n* Total bilirubin =\\\u003C 2 x institutional upper limit of normal (ULN) (obtained =\\\u003C 7 days prior to protocol randomization)\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 3.0 x institutional ULN (obtained =\\\u003C 7 days prior to protocol randomization)\n* Creatinine =\\\u003C 1.5 x institutional ULN OR \\>= 50 mL\u002Fmin.1.73 m\\^2 (obtained =\\\u003C 7 days prior to protocol randomization)\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 with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better\n* Patients must be able to swallow oral tablets and be free of gastrointestinal (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\n  * All patients of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy.\n  * A 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* 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 + cytarabine 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 + cytarabine 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":163,"type":21},184,[55],"This phase II MyeloMATCH treatment trial compares cytarabine versus (vs.) cytarabine and venetoclax vs. liposome-encapsulated daunorubicin-cytarabine and venetoclax vs. azacitidine and venetoclax for treating patients who have residual disease after treatment for acute myeloid leukemia (AML). Cytarabine is in a class of medications called antimetabolites. It works by slowing or stopping the growth of cancer cells in the body. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Liposome-encapsulated daunorubicin-cytarabine is a drug formulation that delivers daunorubicin and cytarabine in small spheres called liposomes, which may make the drugs safer or more effective. Azacitidine is a drug that interacts with DNA and leads to the activation of tumor suppressor genes, which are genes that help control cell growth. This study may help the study doctors find out if the different drug combinations are equally effective to the usual approach of cytarabine alone while requiring a shorter duration of treatment. To decide if they are better, the study doctors will be looking to see if the study drugs lead to a higher percentage of patients achieving a deeper remission compared to cytarabine alone.",[27,167,168,169,30],"Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome","Acute Myeloid Leukemia Arising From Previous Myeloproliferative Neoplasm","Acute Myeloid Leukemia Post Cytotoxic Therapy","NOT_YET_RECRUITING","2026-04-09",{"date":173,"type":35},"2026-04-13",{"date":175,"type":21},"2026-07-01",{"date":177,"type":21},"2026-08-31",{"name":41,"class":42},{"id":180,"slug":181,"hasResults":11,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":4,"eligibilityCriteria":185,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":186,"targetDuration":4,"studyType":22,"phases":188,"briefSummary":189,"conditions":190,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":93},"100490901","phase-1-cd33-car-t-cell-therapy-for-the-treatment-of-recurrent-or-refractory-acute-myeloid-leukemia-100490901","NCT05672147","CD33-CAR T Cell Therapy for the Treatment of Recurrent or Refractory Acute Myeloid Leukemia","Phase I Study of Cellular Immunotherapy Using T Cells Lentivirally Transduced to Express a Cd33-Specific Chimeric Antigen Receptor for Patients With Cd33+ Relapsed\u002FRefractory Acute Myeloid Leukemia","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative\n\n  * Assent, when appropriate, will be obtained per institutional guidelines\n  * For research participants who do not speak English, a short form consent may be used with a City of Hope (COH) certified interpreter\u002Ftranslator to proceed with screening, while the request for a translated full consent is processed\n* Agreement to allow the use of archival tissue from diagnostic tumor biopsies\n\n  * If unavailable, exceptions may be granted with Study principal investigator (PI) approval\n* Age: \\>= 18 years\n* Karnofsky Performance Scale (KPS) \\>= 70\n* Life expectancy \\>= 16 weeks at the time of enrollment\n* Prior allogeneic transplant allowed if \\> 6 months prior to study enrollment\n* Participant must have a confirmed diagnosis of active CD33+ AML de novo, or secondary OR participants who are at a high risk for disease recurrence\n\n  * Relapsed AML is defined as patients that had a first complete response (CR) before developing recurrent disease (increased bone marrow blasts)\n  * Refractory AML is defined as patients that have not achieved a first CR after induction chemotherapy. For patients with AML evolving from myelodysplastic syndrome, they should have completed at least one cycle of induction chemotherapy\n* Research participants must have bone marrow and\u002For peripheral blood samples available for confirmation of diagnosis of AML\n\n  * CD33 positivity must be confirmed by either flow cytometry or immunohistochemistry within 90 days of study entry. Cytogenetics, flow cytometry, and molecular studies (such as FLT-3 status) will be obtained as per standard practice\n  * Research participants who are at a high risk of disease recurrence, they must have historical bone marrow and\u002For peripheral blood samples available for confirmation of diagnosis of AML\n* No known contraindications to lymphodepleting agents, steroids, tocilizumab and\u002For cetuximab, or the investigational agent\n* Total serum bilirubin =\\\u003C 2.0 mg\u002FdL\n* Participants with Gilbert syndrome may be included if their total bilirubin is =\\\u003C 3.0\n* Aspartate aminotransferase (AST) =\\\u003C 3 x the upper limit of normal (ULN)\n* Alanine aminotransferase (ALT) =\\\u003C 3 x ULN\n* Estimated creatinine clearance of \\>= 60 mL\u002Fmin per the Cockcroft-Gault formula, and the participant is not on hemodialysis\n* Left ventricular ejection fraction \\>= 50% within 8 weeks before enrollment\n* Oxygen (O2) saturation \\> 92% not requiring oxygen supplementation\n* Women of childbearing potential (WOCBP): negative urine or serum pregnancy test\n* If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 6 months after the last dose of protocol therapy\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only)\n* Research participants must have a potential donor or stem cell source identified for allogeneic transplantation, either related (7\u002F8 or 8\u002F8 allele matched or haploidentical)\n* DONOR: The identified donor must be the original donor whose stem cells were used for the research participant's allogeneic hematopoietic stem cell transplantation (alloSCT)\n* DONOR: The donor must be HIV negative\n* DONOR: KPS \\>= 70\n* DONOR: Documented body weight\n\nExclusion Criteria:\n\n* Prior allogeneic transplant if \\\u003C 6 months prior to enrollment\n* Concurrent use of systemic steroids or chronic use of immunosuppressant medications should be stopped 28-days prior to enrollment. Recent or current use of inhaled or topical steroids in standard doses is not exclusionary. Physiologic replacement of steroids (prednisone =\\\u003C 7.5 mg\u002Fday, or equivalent doses of other corticosteroids) is allowed\n* Participants with active autoimmune disease, including graft versus host disease (GvHD), requiring systemic immune suppressive should be stopped 28-days prior to enrollment\n* Participants may not be receiving any other investigational agents and are not dependent on concurrent biological therapy, chemotherapy, or radiation therapy\n\n  * With exception to Hydrea which must be stopped prior to initiation of lymphodepletion\n* Research participants on active systemic antifungal treatment within 8 weeks of enrollment are not eligible. However, participants on antifungal prophylaxis are eligible\n\n  * Not applicable at the time of enrollment if the research participant's donor is undergoing leukapheresis\n* Subjects with \\>= Grade 2 myelofibrosis on bone marrow biopsy\n* Subjects with clinically significant arrhythmia or arrhythmias not stable on medical management within two weeks of screening if the patient is undergoing leukapheresis. Patients with controlled atrial arrythmia is allowed\n* Known bleeding disorders (e.g., von Willebrand's disease) or hemophilia\n* History of stroke or intracranial hemorrhage within 6 months prior to screening\n* Subjects with presence of other active malignancy, however, research participants with history of prior malignancy treated with curative intent and in complete remission are eligible\n* Clinically significant uncontrolled illness\n* Active infection requiring antibiotics\n* Research participants who have tested human immunodeficiency virus (HIV) positive, or have active hepatitis B or C infection based on testing performed within 4 weeks of enrollment\n* Active viral hepatitis\n* Females only: Pregnant or breastfeeding\n* Any other condition that would, in the Investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns with clinical study procedures\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)",{"count":187,"type":21},27,[24],"This phase I trial tests the safety, side effects, and the best dose of anti-CD33 chimeric antigen receptor (CAR) T-Cell therapy in treating patients with acute myeloid leukemia that has come back (recurrent) or does not respond to treatment (refractory). CAR T-cell therapy is a type of treatment in which a patient or donor's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's or donor's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor. Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers.",[27,77,112,30],"2026-03-03",{"date":193,"type":35},"2026-03-05",{"date":195,"type":35},"2023-12-07",{"date":197,"type":21},"2028-09-03",{"name":199,"class":92},"City of Hope Medical Center",{"id":201,"slug":202,"hasResults":11,"nctId":203,"briefTitle":204,"officialTitle":205,"acronym":4,"eligibilityCriteria":206,"healthyVolunteers":11,"sex":16,"minAge":207,"maxAge":4,"enrollmentInfo":208,"targetDuration":4,"studyType":22,"phases":210,"briefSummary":211,"conditions":212,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":220,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":93},"100334179","phase-1-edetate-calcium-disodium-or-succimer-in-treating-patients-with-acute-myeloid-leukemia-or-myelodysplastic-syndrome-undergoing-chemotherapy-100334179","NCT03630991","Edetate Calcium Disodium or Succimer in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome Undergoing Chemotherapy","Monitoring, Detoxifying, and Rebalancing Metals During Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) Therapy","Inclusion Criteria:\n\n* Patients ≥18 years of age, or their legally authorized representative (LAR), must have the ability to understand the requirements of the study and must voluntarily sign the informed consent form. For patients \\\u003C18 years of age, a parent or LAR must have the ability to understand the requirements of the study and must voluntarily sign the informed consent form. Any required verbal assent and\u002For signed assent of minor must be obtained for participants \\\u003C18 years.\n* Age ≥18 years at the time of signing the informed consent form.\n* Age ≥1 years and \\\u003C18 years with weight requirement ≥8 kg at the time of the signing of the informed consent form (e.g. by parent or LAR)\n* Patients enrolling in the pediatric\u002Fadolescent\u002Fyoung adult exploratory cohort must be:\n\nAge ≥ 1 years and \\\u003C18 years with weight requirement ≥8 kg at the time of the signing of the informed consent form (e.g. by parent or LAR), Or age 18 years -39 years at the time of the signing of the informed consent form\n\n* Diagnosis of any of the following:\n* Newly diagnosed (or untreated) AML with intermediate-risk\u002Fpoor-risk cytogenetics, intermediate-risk\u002Fpoor-risk molecular, or secondary AML (i.e. therapy-related or evolved from antecedent hematologic malignancy)\n* Newly diagnosed (or untreated) myeloid blast phase of myeloproliferative neoplasm (MPN) (including myeloid blast phase of chronic myeloid leukemia \\[CML\\])\n* Newly diagnosed (or untreated) high-risk, very-high risk or secondary MDS\u002Fmyeloid neoplasm\n* Newly diagnosed (or untreated) MDS\u002FMPN (regardless of cytogenetic\u002Fmolecular status)\n* Relapsed and\u002For refractory AML, MDS\u002Fmyeloid neoplasm , MDS\u002FMPN, myeloid blast phase of MPN (including myeloid blast phase of CML)\n* Patients enrolling in the childhood\u002Fadolescent\u002Fyoung adult exploratory cohort may have any of the following diagnoses:\n* High-risk or relapsed\u002Frefractory childhood, adolescent, or young adult malignancies including but not limited to high-risk or relapsed\u002Frefractory ALL or other high-risk or relapsed refractory malignancies\n* This includes, but is not limited to, the following: High-risk ALL\u002FLL including T-ALL\u002FLL, Ph-like ALL\u002FLL, Ph+ B-ALL\u002FLL, B-ALL\u002FLL with CNS lymphoid leukemic involvement, testicular involvement, other extramedullary involvement by ALL\u002FLL; ALL\u002FLL with any of the NCI high-risk features: patients aged 10 years or older and those with a white blood cell count ≥50 × 109 per L), high-risk cytogenetics (MLL rearrangements, near haploidy \\[\\\u003C30 chromosomes\\], low hypodiploidy \\[30-39 chromosomes\\], t\\[17;19\\]\\[q23;p13\\], intrachromosomal amplification of chromosome 21), Burkitts'; Burkitt's-like, Double-Hitt; CNS involvement by any non-primary brain malignancy; Metastatic disease of any malignancy; 5-year survival prognosis of less than 50%, based on the treating physician's assessment\n* Patients on non-investigational regimens or on IND-exempt MD Anderson studies (for hematologic malignancies) of approved drugs are also eligible.\n* Patients on IND studies (for hematologic malignancies) utilizing FDA approved commercially available drugs are eligible.\n* Investigational agents that are not used for treatment of the leukemia per se (e.g. anti-infective prophylaxis or therapy) will be allowed. Other supportive care studies are allowed, even if under an IND.\n* Newly diagnosed MDS or AML, as well as MDS\u002FMPN, myeloid blast phase of MPN (including myeloid blast phase of CML), patients can enroll on this study after start of non-investigational induction therapy, but must be within first 3 cycles of therapy of front-line therapy. Patients with relapsed and\u002For refractory AML, MDS, MDS\u002FMPN, myeloid blast phase of MPN (including myeloid blast phase of CML) can enroll. Newly diagnosed patients enrolling in the exploratory cohort with high-risk malignancies can enroll after the start of non-investigational therapy but must be within first 3 cycles of front-line therapy.\n* Transformed and untreated AML transformed from previously treated MDS, myeloproliferative neoplasm (MPN) or other types of secondary AML are allowed. Myeloid-Blast Phase of MPN and Chronic Myeloid Leukemia (CML) are allowed.\n* Eastern Cooperative Oncology Group (ECOG) performance status of =\\\u003C 3 or Lansky or Karnofsky ≥ 30 at study entry; patients who are unable to walk, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.\n* Laboratory test results within these ranges (unless due to leukemia or other hematologic malignancy):\n* Serum creatinine =\\\u003C 1.5 mg\u002FdL\n* Total Bilirubin =\\\u003C 2.0 x upper limit of normal (ULN), unless the patient has Gilbert's\n* AST (SGOT) and\u002For ALT (SGPT) =\\\u003C 2.0 x ULN\n* Women of childbearing potential (WCBP) must have a negative urine pregnancy test within 7 days and must either commit to continued abstinence from heterosexual intercourse or adopting at least one highly effective method of contraception. These methods include intra-uterine device, tubal ligation, partner's vasectomy, and hormonal birth control pills. Men must agree not to father a child and agree to use a condom if his partner is of child bearing potential\n* Extramedullary disease is allowed as long as it can be measured and followed for response.\n\nNote: Patients can be considered MDS by either WHO or FAB150 criteria Note: MDS risk status assessment is based on IPSS-R and\u002For IPSS-M. AML risk status assessment is based on ELN and World Health Organization classification\n\nExclusion Criteria:\n\n* Nursing and pregnant females. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately\n* Uncontrolled inter-current illness including, but not limited to, uncontrolled active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements or which judged by the investigator, places the patient at unacceptable risk\n* Acute Promyelocytic leukemia (APL)","1 Year",{"count":209,"type":21},58,[24],"This phase I trial studies the side effects and best dose of edetate calcium disodium or succimer in treating patients with acute myeloid leukemia or myelodysplastic syndrome undergoing chemotherapy. Edetate calcium disodium or succimer may help to lower the level of metals found in the bone marrow and blood and may help to control the disease and\u002For improve response to chemotherapy.",[27,167,107,213,214,71,74,215,76,111,140,216,112,113,144,30,217,218],"Chronic Myelogenous Leukemia, BCR-ABL1 Positive","High Risk Myelodysplastic Syndrome","Myeloproliferative Neoplasm","Recurrent Myelodysplastic\u002FMyeloproliferative Neoplasm","Secondary Myelodysplastic Syndrome","Very High Risk Myelodysplastic Syndrome","2026-02-26",{"date":221,"type":35},"2026-03-02",{"date":223,"type":35},"2018-10-11",{"date":225,"type":21},"2027-04-30",{"name":91,"class":92},{"id":228,"slug":229,"hasResults":11,"nctId":230,"briefTitle":231,"officialTitle":232,"acronym":4,"eligibilityCriteria":233,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":234,"targetDuration":4,"studyType":22,"phases":235,"briefSummary":236,"conditions":237,"keywords":239,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":252,"locationsCount":254},"100501336","phase-1-venetoclax-in-addition-to-sequential-conditioning-with-fludarabine--amsacrine--ara-c-flamsa--treosulfan-for-allogeneic-blood-stem-cell-transplantation-in-patients-with-mds-cmml-or-saml-100501336","NCT05807932","Venetoclax in Addition to Sequential Conditioning With Fludarabine \u002F Amsacrine \u002F Ara-C (FLAMSA) + Treosulfan for Allogeneic Blood Stem Cell Transplantation in Patients With MDS, CMML or sAML","Phase-I\u002FII Trial to Assess the Safety and Efficacy of Venetoclax in Addition to Sequential Conditioning With Fludarabine \u002F Amsacrine \u002F Ara-C (FLAMSA) + Treosulfan for Allogeneic Blood Stem Cell Transplantation in Patients With MDS, CMML or sAML (FLAMSAClax","Inclusion Criteria:\n\n* Subjects must voluntarily sign and date an informed consent, approved by an independent ethics committee (IEC), prior to the initiation of any study-specific procedures\n* MDS, CMML or sAML according to WHO classification (revised version 2016) with a marrow blast count \\>5% and\u002For high-risk genetic features (e.g. bad risk karyotype according to the IPSS-R \u002F ELN classification or presence of unfavorable somatic mutations (e.g. TP53, RUNX1, IDH1, IDH2, KMT2A, DEK-NUP214 or RAS pathway mutations including NRAS, KRAS, PTPN11, CBL, NF1, RIT1 or KIT), falling into the \"high\" or \"very high\" risk category of the IPSS-R or IPSS-M) any time between diagnosis and inclusion\n* Untreated except for oral Hydroxyurea or a maximum of 2 courses of treatment with Azacytidine or Decitabine alone or in combination with Venetoclax\n* Identification of a well matched (10 out of 10, A, B, C, DR, DQ) donor either related or unrelated\n* Age ≥18\n* HCT-CI ≤ 3 (except former treatment of a solid tumor)\n* ECOG performance status ≤ 2 at study entry\n* no active, uncontrolled infection at inclusion\n* able to adhere to the study visit schedule and other protocol requirements\n* Female of childbearing potential (FCBP) must:\n\n  * Understand that based on embryo-foetal toxicity studies in animals venetoclax may harm the foetus when administered to pregnant woman\n  * Agree to have a medically supervised pregnancy test at Screening and within 72 hours prior treatment start\n  * Avoid becoming pregnant while receiving Venetoclax\n  * Use effective contraception during treatment with Venetoclax and for at least 1 months after the last dose,\n  * Understand that is currently unknown whether venetoclax may reduce the effectiveness of hormonal contraceptives, and therefore women using hormonal contraceptives should add a barrier method\n  * Notify her study doctor immediately if there is a risk of pregnancy\n* Males must:\n\n  * agree to use condoms, even if the male subject has undergone a successful vasectomy, from Study Day 1 through at least 30 days after the last dose of study drug.\n  * Agree to notify the investigator immediately, if pregnancy or a positive pregnancy test occurs in his partner during study participation\n\nExclusion Criteria:\n\n* sAML with known FLT3 mutation (ITD or TKD)\n* Marrow blast count \\>30% at the time of screening\n* Peripheral white blood count \\>20,000 per microliter despite treatment with Hydroxyurea\n* previous cytotoxic therapy exceeding oral Hydroxyurea or \\>2 courses of treatment with Azacytidine, Decitabine or low dose Ara-C alone or in combination with Venetoclax\n* previous allogeneic blood stem cell transplantation\n* symptomatic CNS-involvement with MDS; CMML or sAML\n* any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form\n* pregnant or lactating females\n* Refusal to use safe contraceptive methods during the study period\n* Cardiac history of CHF (\\>NYHA 2) requiring treatment or Ejection Fraction \\\u003C 40% or chronic stable angina\n* Forced expiratory volume in 1 second (FEV1) \\\u003C50% of expected corrected for hemoglobin and\u002For volume\n* Diffusing capacity of the lungs for carbon monoxide (DLCO) \\\u003C50% of expected corrected for hemoglobin and\u002For volume\n* any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he\u002Fshe were to participate in the study or confounds the ability to interpret data from the study:\n\n  * Impaired renal function (GFR \\\u003C 45 ml\u002Fmin)\n  * Impaired hepatic function, as follows Aspartate aminotransferase (AST) ≥3 x ULN or Alanine aminotransferase (ALT) ≥3 x ULN or Total bilirubin ≥1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin) or Alkaline Phosphatase ≥3 x ULN\n* known hypersensitivity to Venetoclax, Fludarabine, Amsacrine, Ara-C or Treosulfan\n* concurrent use of other anti-cancer agents or treatments except Hydroxyurea and a maximum of 2 courses of Azacytidine or Decitabine\n* positive for HIV or replicating infectious hepatitis, type A, B, C or E\n* prior history of malignancy other than MDS, CMML, sAML (except basal cell or squamous cell carcinoma or carcinoma in situ of the cervix or breast) unless the subject has been free of disease for ≥ 2 years\n* participation in another study with ongoing use of unlicensed investigational product from 28 days or \\\u003C5 half-lifes of the investigational product before study enrollment\n* No planned or executed\u002Fgiven treatment with any of the following within 7 days prior to the first dose of study drug (or ramp-up prophase):\n\n  * Steroid therapy for anti-neoplastic intent\n  * moderate or strong cytochrome P450 3A (CYP3A) inhibitors\n  * moderate or strong CYP3A inducers\n* Refusal to avoid consumption of any of the following within 3 days prior to the first dose of study drug: grapefruit or grapefruit products, Seville oranges (including marmalade containing Seville oranges), star fruit.\n* Persons with any kind of dependency on the investigator or employed by the sponsor or investigator\n* Persons held in an institution by legal or official order",{"count":20,"type":21},[24,55],"This trial aims to find the MTD of Venetoclax when added to Fludarabin, Amsacrine and Ara-C + Treosulfan and to evaluate whether the addition of Venetoclax to sequential conditioning with FLAMSA + Treosulfan is safe for allogeneic blood stem cell transplantation in patients with high-risk MDS, CMML or sAML (FLAMSAClax)",[238,30,66],"Myelodysplastic Syndromes",[240,241,242,243,244],"MDS","sAML","CMML","allogeneic blood stem cell transplantation","Venetoclax","2024-04-30",{"date":247,"type":35},"2024-05-01",{"date":249,"type":35},"2023-06-26",{"date":251,"type":21},"2028-01-30",{"name":253,"class":92},"Heinrich-Heine University, Duesseldorf",6,{"id":256,"slug":257,"hasResults":11,"nctId":258,"briefTitle":259,"officialTitle":260,"acronym":4,"eligibilityCriteria":261,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":51,"enrollmentInfo":262,"targetDuration":4,"studyType":22,"phases":264,"briefSummary":265,"conditions":266,"keywords":268,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":274,"lastUpdatePostDateStruct":275,"startDateStruct":277,"completionDateStruct":279,"leadSponsor":281,"locationsCount":93},"100484186","phase-1-unrelated-umbilical-cord-blood-stem-cell-combined-with-azacitidine-based-treatment-for-advanced-mdscmml-2-and-saml-100484186","NCT05584761","Unrelated Umbilical Cord Blood Stem Cell Combined With Azacitidine Based Treatment for Advanced MDS,CMML-2 and sAML","A Perspective, Multicenter, Open-label and Observational Trial for Unrelated Umbilical Cord Blood Stem Cell Microtransplantation Combined With Azacitidine Based Treatment for Advanced MDS,CMML-2 and Secondary AML.","1. MDS patients diagnosed due to bone marrow morphology and immunophenotyping (met the World Health Organization(WHO) 2016 diagnosis criterion) and met revised the International Prognostic Scoring System(IPSS) prognostic risk categories intermediate(\\>3-≤4.5), high(\\>4.5-≤6), and very high risk(\\>6), or CMML-2(PB 5-19% or bone marrow 10-19% blast equivalent, and\u002For when any Auer rods are present) patients diagnosed due to bone marrow morphology and immunophenotyping (met the WHO 2016 diagnosis criterion) with white blood cell count(WBC)\\\u003C13x109\u002FL, or AML patients diagnosed due to bone marrow morphology and immunophenotyping (met the WHO 2016 diagnosis criterion) with history of myeloid neoplasms ;\n2. Ineligible for allogeneic hematopoietic stem cell transplantation (HSCT) based on local medical standards and clinical decision guidelines in the study;\n3. Indications for azacytidine (AZA) treatment were determined according to local medical standards and diagnostic decision guidelines in the study;\n4. Morphology and immunophenotyping excluded BCR\u002FABL positive chronic myelogenous leukemia and other myeloid neoplasms including essential thrombocythemia, polycythemia vera and primary myelofibrosis;\n5. Aged 18-80 years old;\n6. Alanine transaminase(ALT), Aspartate Transaminase(AST) and serum bilirubin \\\u003C=2 upper limit of normal (ULN), serum creatinine \\\u003C=150umol\u002FL, myocardial enzyme \\\u003C2xULN (of the same age);\n7. Left ventricularinjection fraction(LVEF)\\>=50% by echocardiogram;\n8. Estimated glomerular filtration rate (eGFR) ≥30mL\u002Fmin\u002F1.73m2 ;\n9. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; 10. must sign (or their legally-acceptable representative must sign) an informed consent form indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study.\n\nExclusion Criteria:\n\n1. BCR\u002FABL positive chronic myelogenous leukemia, primary myelofibrosis, polycythemia vera and essential thrombocythemia;\n2. Low risk myelodysplastic syndromes according to IPSS or revised IPSS prognostic risk categories;\n3. Acute promyelocytic leukemia, myeloid sarcoma, or accelerated or blastic phase of chronic myelogenous leukemia;\n4. Allergic to any of the mentioned agent in the study protocol;\n5. Pregnant or lactating women, or patients during reproductive stage but not willing to take contraception methods;\n6. With obvious dysfunction of liver or kidney, not fulfilling the inclusion criteria;\n7. With organic heart disease, which causes clinical symptoms or cardiac dysfunction ( ≥ Class 2 cardiac disease as defined by the New York Heart Association Functional Classification, NYHA );\n8. At the same time suffering from other malignant tumors, with the exception of the following: (1) malignancy treated with curative intent and with no evidence of active disease present for more than 5 years prior to screening; (2) adequately treated lentigo maligna melanoma without current evidence of disease or adequately-controlled non-melanomatous skin cancer (even if less than 3 years prior to screening); (3) adequately treated cervical carcinoma in situ without current evidence of disease (even if less than 3 years prior to screening);\n9. Known history of human immunodeficiency virus (HIV) or syphilis, or active infection with Hepatitis B (HBV-DNA positive) or Hepatitis C;\n10. Currently active clinically significant cardiovascular disease such as uncontrolled arrhythmia, congestive heart failure, or history of myocardial infarction within 6 months prior to first dose with study drug, or any Class 3 or 4 cardiac disease as defined by NYHA;\n11. Any concurrent medical condition or disease (eg, active systemic infection) that may interfere with the research procedure or outcome, or that the subject may have a risk to participate in the study;\n12. Cannot understand or follow the study protocol;\n13. Patients under 12 years old or over 80 years old;\n14. Received major surgery within 4 weeks prior to randomization;\n15. Participated in other clinical researches at the same time one month before enrollment;\n16. Cannot matching suitable cord blood stem cell;\n17. Addicted to illegal drugs;\n18. Have mental disorders or cognitive disorders.",{"count":263,"type":21},50,[24,55],"This research is being done to study the efficacy and safety of unrelated umbilical cord blood stem cell microtransplantation combined with azacitidine(AZA) based treatment for advanced myelodysplastic syndromes(MDS), Chronic myelomonocytic leukemia-2(CMML-2) and secondary acute myeloid leukemia(sAML). The study protocol involved unrelated umbilical cord blood stem cell combined with azacitidine based treatment, which including azacitidine alone and azacitidine plus a targeted agent or chemotherapy agent.",[238,267,30],"Chronic Myelomonocytic Leukemia-2",[269,270,271,272,273],"umbilical cord blood stem cell","microtransplantation","myelodysplastic syndromes","Chronic myelomonocytic leukemia","secondary acute myeloid leukemia","2022-10-16",{"date":276,"type":35},"2022-10-18",{"date":278,"type":35},"2022-03-01",{"date":280,"type":21},"2026-12-31",{"name":282,"class":92},"The First Affiliated Hospital with Nanjing Medical University"]