[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acute-leukemia-of-ambiguous-lineage\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acute-leukemia-of-ambiguous-lineage":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,14,0,[8,41,68,78,104,143,168,204,246,272,294,318,340,361],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100053688","phase-2-testing-the-addition-of-the-anti-cancer-drug-venetoclax-andor-the-anti-cancer-immunotherapy-blinatumomab-to-the-usual-chemotherapy-treatment-for-infants-with-newly-diagnosed-kmt2a-rearranged-or-kmt2a-non-rearranged-leukemia-100053688",false,"NCT06317662","Testing the Addition of the Anti-cancer Drug Venetoclax and\u002For the Anti-cancer Immunotherapy Blinatumomab to the Usual Chemotherapy Treatment for Infants With Newly Diagnosed KMT2A-rearranged or KMT2A-non-rearranged Leukemia","A Phase 2 Study of Blinatumomab in Combination With Chemotherapy for Infants With Newly Diagnosed Acute Lymphoblastic Leukemia With Randomization of KMT2A-Rearranged Patients to Addition of Venetoclax","Inclusion Criteria:\n\n* All patients must be enrolled on APEC14B1 and consented to eligibility screening (part A) prior to treatment and enrollment on AALL2321\n* Infants (aged 365 days or less) on the date of diagnosis are eligible; infants must be \\> 36 weeks gestational age at the time of enrollment\n* Patients must have newly diagnosed B-acute lymphoblastic leukemia (B-ALL, 2017 World Health Organization \\[WHO\\] classification), also termed B-precursor ALL, or acute leukemia of ambiguous lineage (ALAL), which includes mixed phenotype acute leukemia. For patients with ALAL, the immunophenotype of the leukemia must comprise at least 50% B lineage\n\n  * Diagnostic immunophenotype: Leukemia cells must express CD19\n\nExclusion Criteria:\n\n* Patients with Down Syndrome\n* Patients with secondary B-ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy\n* Patients must not have received any cytotoxic chemotherapy for either the current diagnosis of infant ALL or for any cancer diagnosis prior to the initiation of protocol therapy, with the exception of:\n\n  * Steroid pretreatment:\n\n    * PredniSONE, prednisoLONE, or methylPREDNISolone for ≤ 72 hours (3 days) in the 7 days prior to enrollment. The dose of predniSONE, prednisoLONE or methylPREDNISolone does not affect eligibility\n    * Inhaled and topical steroids are not considered pretreatment\n    * Note: Pretreatment with dexamethasone in the 28 days prior to initiation of protocol therapy is not allowed with the exception of a single dose of dexamethasone used during or within 6 hours prior to or after sedation to prevent or treat airway edema. However, prior exposure to ANY steroids that occurred \\> 28 days before enrollment does not affect eligibility\n  * Intrathecal cytarabine or methotrexate:\n\n    * An intrathecal dose of cytarabine or methotrexate in the 7 days prior to enrollment does not affect eligibility\n    * Note: The preference is to defer the diagnostic lumbar puncture with intrathecal chemotherapy to day 1 of induction to allow for cytoreduction of circulating blasts and decrease the potential for central nervous system (CNS) contamination due to a traumatic tap. If done prior to day 1 of induction, these results will be used to determine CNS status\n  * Hydroxyurea:\n\n    * Pretreatment with ≤ 72 hours (3 days) of hydroxyurea in the 7 days prior to enrollment does not affect eligibility\n* All patients and\u002For their parents or legal guardians must sign a written informed consent\n* All institutional, Food and Drug Administration (FDA) and National Cancer Institute (NCI) requirements for human studies must be met","ALL","365 Days",{"count":19,"type":20},153,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This phase II trial tests the addition of venetoclax and\u002For blinatumomab to usual chemotherapy for treating infants with newly diagnosed acute lymphoblastic leukemia (ALL) with a KMT2A gene rearrangement (KMT2A-rearranged \\[R\\]) or without a KMT2A gene rearrangement (KMT2A-germline \\[G\\]). 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. Blinatumomab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Chemotherapy drugs 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 venetoclax and\u002For blinatumomab to standard chemotherapy may be more effective at treating patients with ALL than standard chemotherapy alone, but it may also cause more side effects. This clinical trial evaluates the safety and effectiveness of adding venetoclax and\u002For blinatumomab to chemotherapy for the treatment of infants with KMT2A-R or KMT2A-G ALL.",[26,27],"Acute Leukemia of Ambiguous Lineage","B Acute Lymphoblastic Leukemia","RECRUITING","2026-07-10",{"date":31,"type":32},"2026-07-13","ACTUAL",{"date":34,"type":32},"2025-06-05",{"date":36,"type":20},"2028-12-31",{"name":38,"class":39},"National Cancer Institute (NCI)","NIH",113,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":67},"100600227","randomization-for-the-identification-of-best-treatment-intensity-for-less-fit-adults-with-acute-myeloid-leukemia-and-myeloid-neoplasms-100600227","NCT07094750","Randomization for the Identification of Best Treatment Intensity for Less Fit Adults With Acute Myeloid Leukemia and Myeloid Neoplasms","Impact of Treatment Intensity on Survival, Quality of Life, and Resource Utilization in Medically Less Fit Adults With Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms: A Randomized Pilot Study","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Diagnosis of high grade myeloid neoplasm (\\> 10% blasts in blood or marrow), other than acute promyelocytic leukemia (APL) according to the 2022 International Consensus Classification (ICC) classification. Patients with acute leukemias of ambiguous lineage are eligible\n* The use of cytoreductive therapy before treatment is permitted. Patients with symptoms\u002Fsigns of leukostasis, white blood cell (WBC) \\> 100,000\u002FμL, or acute symptoms that in the opinion of the treating physician are likely related to their high-grade myeloid neoplasm may receive up to 2 doses of cytarabine (up to 500 mg\u002Fm\\^2 each) prior to study day 1\n* Patients may have received treatment for antecedent low-grade myeloid neoplasm (\\\u003C 10% myeloid blasts on blood or bone marrow)\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 3 (for patients aged \\\u003C 75 years) or ECOG performance status of 0 - 2 (for patients aged ≥ 75 years)\n* The presence of one or more of the following criteria for 'unfitness'. (Patients without respiratory symptoms at rest are eligible and should only complete spirometry\u002Fdiffusion capacity of the lung for carbon monoxide \\[DLCO\\] measurements as clinically indicated):\n\n  * ECOG Performance Status of 2 or 3\n  * Cardiac history of congestive heart failure (CHF) requiring treatment or ejection fraction ≤ 50% or chronic stable angina\n  * Documented DLCO ≤ 65% or forced expiratory volume in 1 second (FEV1) ≤ 65%; or dyspnea at rest, or requiring supplemental oxygen\n  * Creatinine clearance ≥ 30 mL\u002Fmin to \\\u003C 45 ml\u002Fmin\n  * Moderate hepatic impairment with total bilirubin \\> 1.5 to ≤ 3.0 × upper limit of normal (ULN)\n  * Any other comorbidity that the physician judges to be incompatible with intensive chemotherapy\n* Adequate cardiac function:\n\n  * Patients aged ≤ 60 years without a history of cardiac disease or evidence of heart failure are eligible if they also exhibit the following:\n\n    * Chest x-ray (CXR) without evidence of moderate or severe pulmonary edema or pleural effusion, and a normal cardio-mediastinal silhouette\n    * Electrocardiogram (ECG) without evidence of atrial or ventricular chamber enlargement\n    * Note that patients with either abnormal CXR or ECG should have a structural heart assessment (echocardiogram, multigated acquisition scan \\[MUGA\\] or similar) and are eligible if left ventricular ejection fraction (LVEF) \\> 40% and the abnormalities in the CXR\u002FECG do not preclude safe administration of intensive chemotherapy\n  * Patients with a documented left ventricular ejection fraction (LVEF) ≥ 40%, assessed within 3 months prior to registration, e.g. by MUGA scan or echocardiography, or another appropriate diagnostic modality are eligible\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3x ULN, unless judged due to leukemic organ involvement\n* Total bilirubin ≤ 3 x ULN unless judged due to leukemic organ involvement, Gilbert's syndrome, or hemolysis\n* Women of childbearing potential and men must agree to use adequate contraception beginning at the signing of the consent until at least 4 weeks after the last dose of study drug\n* HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Known hypersensitivity to cytarabine, anthracycline, hypomethylating agents, or venetoclax\n* Cardiovascular disability status of New York Heart Association class ≥ 2. Class 2 is defined as cardiac disease in which patients are comfortable at rest but ordinary physical activity results in fatigue, palpitations, dyspnea, or anginal pain\n* Subject exhibits evidence of other clinically significant uncontrolled systemic infection requiring therapy (viral, bacterial or fungal)\n* Concomitant illness associated with a likely survival of \\\u003C 1 year\n* Active pregnancy or breast feeding","18 Years",{"count":50,"type":20},50,[52],"NA","This clinical trial studies whether less fit adults with acute myeloid leukemia (AML) or myeloid neoplasms are willing to let a computer program decide (randomization) whether they receive lower- or higher-intensity chemotherapy. Historically, treatment decision-making for patients with AML or myeloid neoplasms has divided patients into two categories, with patients considered fit receiving intensive \"curative\" chemotherapy, and patients considered unfit, such as older patients with a higher risk of early death from therapy, receiving non-intensive \"palliative\" therapy or no therapy. With the introduction of new treatment agents, it has become difficult to determine the difference between intensive and non-intensive therapy, especially for patients considered unfit for whom treatment-related side effects remain a concern. Treatment intensity is best identified through randomized trials but often patients are unwilling to undergo randomization due to preset beliefs. However, with improved supportive care and the awareness that new treatment agents may have similar risks as intensive therapy, it may be possible that more patients are willing to be randomized. This may help identify the best treatment intensity for less fit adults with AML or myeloid neoplasms, which may improve outcomes.",[26,55,56],"Acute Myeloid Leukemia","Myeloid Neoplasm","2026-06-10",{"date":59,"type":32},"2026-06-12",{"date":61,"type":20},"2026-07-01",{"date":63,"type":20},"2029-06-08",{"name":65,"class":66},"Fred Hutchinson Cancer Center","OTHER",1,{"id":69,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":17,"enrollmentInfo":70,"targetDuration":4,"studyType":21,"phases":71,"briefSummary":24,"conditions":72,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":76,"leadSponsor":77,"locationsCount":40},"100540501",{"count":19,"type":20},[23],[26,27],{"date":74,"type":32},"2026-06-11",{"date":34,"type":32},{"date":36,"type":20},{"name":38,"class":39},{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":16,"minAge":85,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":21,"phases":88,"briefSummary":89,"conditions":90,"keywords":4,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":4},"100642839","phase-2-testing-blinatumomab-with-or-without-revumenib-in-patients-with-b-cell-acute-lymphoblastic-leukemia-with-a-genetic-change-requiring-more-treatment-100642839","NCT07636564","Testing Blinatumomab With or Without Revumenib in Patients With B-cell Acute Lymphoblastic Leukemia With a Genetic Change Requiring More Treatment","A Phase II Randomized Study of Blinatumomab With or Without Revumenib for Patients With KMT2A-Translocation B-Cell Acute Lymphoblastic Leukemia (ALL)\u002F Acute Leukemia With Ambiguous Lineage (ALAL) With Persistent Measurable Residual Disease (MRD)","Inclusion Criteria:\n\n* COHORT A: Participants must meet diagnostic criteria for either B-cell acute lymphoblastic leukemia (ALL) with KMT2A-translocation or acute leukemia with ambiguous lineage (ALAL) with KMT2A-translocation\n* COHORT A: Participants must have KMT2A-translocation documented locally by conventional cytogenetics, fluorescence in situ hybridization (FISH) or molecular studies such as next generation sequencing (NGS)\n* COHORT A: Participants must have achieved morphological first complete remission (CR1) after induction cycle (s) as defined bone marrow lymphoblasts \\\u003C 5%\n* COHORT A: Participants must have either known trackable clone(s) by clonoSEQ that was identified at initial diagnosis, or a banked diagnostic sample, which can include clinical samples from the treating institution, available that can be used to identify trackable clone(s)\n\n  * Participants must not be known not to have trackable clones by clonoSEQ\n  * Participants must not be known already to have MRD-negativity by clonoSEQ prior to enrollment\n* COHORT A: Participants must have evidence of CD19 expression at any level in ALL or ALAL documented locally by flow cytometry or immunohistochemistry in bone marrow or peripheral blood at the time of initial diagnosis. Immunophenotyping of the blood or marrow lymphoblasts must be performed to determine lineage. Appropriate marker studies including CD19 (B cell) must be performed. If a bone marrow aspirate cannot be obtained despite an attempt (dry tap), appropriate Immunohistochemistry (IHC) testing, including CD19, must be performed on the bone marrow biopsy to determine lineage\n* COHORT A: Participants must have Philadelphia-chromosome negative ALL or ALAL\n* COHORT A: Participants must not have known lymphoid blast crisis arising from chronic myeloid leukemia (CML) or have received previous tyrosine kinase inhibitor (TKI) therapy for their chronic myeloid leukemia (CML)\n* COHORT B: Participants must meet diagnostic criteria for either newly diagnosed with acute lymphoblastic leukemia (ALL) or acute leukemia with ambiguous lineage (ALAL)\n\n  * Participants with either B or T-cell subtypes of ALL are permitted on Cohort B\n  * Participants must have KMT2A-translocation documented locally by conventional cytogenetics, fluorescence in situ hybridization (FISH) or molecular studies such as next generation sequencing (NGS)\n* COHORT B: Participants must have Philadelphia-chromosome negative ALL or ALAL\n* COHORT B: Participants must not have known lymphoid blast crisis arising from CML or have received previous TKI therapy for their chronic myeloid leukemia (CML)\n* COHORT A: Participants ≥ 18 years may have received 1 to 3 cycles of induction\u002Fconsolidation before entering the study. It is encouraged to enroll participants immediately after completing the first induction cycle if the patient achieves morphological CR. For pediatric patients \\\u003C 18 years of age, enrollment must occur after induction therapy\n* COHORT A: Participants must discontinue strong cytochrome P450 (CYP)3A4 inhibitors or strong or moderate inducers, except corticosteroids, within 14 days prior to registration\n* COHORT A: Participants must have recovered from any prior major surgery adverse effects at least 14 days prior to registration, to the satisfaction of the local investigator\n\n  * Note: Central venous access placement is not considered major surgery for the purposes of this protocol\n* COHORT A: Participants must not be receiving any oral or intravenous systemic immunosuppressive therapy with the exception of induction\u002Fconsolidation chemotherapy for the treatment of their current ALL or ALAL. Participants may receive up to 10 mg per day of prednisone or prednisone equivalent for adrenal insufficiency or other indications\n* COHORT A: Participants must not have received a prior allogeneic hematopoietic stem cell transplant\n* COHORT A: Participants must not have received prior blinatumomab, menin inhibitors, chimeric antigen receptor (CAR)-T therapy, or anti-CD19 antibodies\n* COHORT B: Participants must not have received prior systemic therapy for ALL or ALAL, with the exception of hydroxyurea, steroid, retinoic acid, intrathecal chemotherapy, or induction chemotherapy as defined below\n\n  * Participants who have been started on the study regimen backbone (i.e. induction therapy) before consenting and then are found to have the KMT2Ar and are eligible for the study, can be enrolled on the study as long as revumenib treatment can be started by day 8 of induction therapy\n* COHORT B: Participants must discontinue strong CYP3A4 inhibitors or strong or moderate inducers, except corticosteroids, within 14 days prior to registration\n* COHORT B: Participants must have recovered from any prior major surgery adverse effects at least 14 days prior to registration, to the satisfaction of the local investigator\n\n  * Note: Central venous access placement is not considered major surgery for the purposes of this protocol\n* COHORT B: Participants must not be receiving any systemic oral or intravenous immunosuppressive therapy with the exception of induction chemotherapy or corticosteroid for the treatment of their current ALL or ALAL\n* COHORT B: Participants must not have received a prior allogeneic hematopoietic stem cell transplant\n* COHORT A: Participant must be ≥ 1 years old at the time of registration. There is no upper age limit\n* COHORT A: Participant must have Zubrod\u002FEastern Cooperative Oncology Group (ECOG) performance status of 0-2, or Lansky\u002FKarnofsky performance status scores of 50-100\n* COHORT A: Participants must have a complete medical history and physical exam within 28 days prior to registration\n* COHORT A: Glomerular filtration rate (GFR) ≥ 50 ml\u002Fmin\u002F1.73 m\\^2 (within 14 days prior to registration)\n* COHORT A: Absolute neutrophil count ≥ 1 x 10\\^3\u002FuL (within 14 days prior to registration)\n* COHORT A: Platelets ≥ 100 x 10\\^3\u002FuL (within 14 days prior to registration)\n* COHORT A: Direct bilirubin ≤ 2.0 mg\u002FdL (34.2 micromoles\u002FL) (within 14 days prior to registration)\n\n  * Note: Participants with history of Gilbert's disease must have direct bilirubin ≤ 5 x institutional upper limit of normal (ULN)\n* COHORT A: Alanine aminotransferase (ALT) ≤ 5 x institutional ULN (within 14 days prior to registration)\n* COHORT A: Participants ≥ 18 years must have a calculated creatinine clearance ≥ 50 mL\u002Fmin using the following Cockcroft-Gault formula. This specimen must have been drawn and processed within 14 days prior to registration\n* COHORT A: Adequate renal function for participants \\\u003C 18 years of age is defined as:\n\n  * A GFR ≥ 50 mL\u002Fmin\u002F1.73 m\\^2, as determined by one of the following methods:\n\n    * Estimated GFR (eGFR) ≥ 50 mL\u002Fmin\u002F1.73 m\\^2 \"Bedside\" Schwartz formula (2009)\n    * Measured GFR ≥ 50 mL\u002Fmin\u002F1.73 m\\^2 (any age). If measured GFR is used, it must be performed using direct measurement with a nuclear blood sampling method or small molecule clearance method (iothalamate or other molecule per institutional standard)\n* COHORT A: Participants must have adequate cardiac function. Participants must have cardiac ejection fraction ≥ 50% by MUGA or 2 dimensional (2-D) echocardiogram or shortening fraction (SF) ≥ 27% by echocardiogram within 90 days prior to registration. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants must be class 2B or better\n* COHORT A: Participants ≥ 18 years of age with a known history of human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load test on the most recent test results obtained within 6 months prior to registration\n* COHORT A: Participants ≥ 18 years of age with a known history of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to registration, if indicated\n* COHORT A: Participants ≥ 18 years of age with a known history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 6 months prior to registration, if indicated\n* COHORT A: Participants must not have prolonged Fridericia's formula-corrected QT interval (QTcf) defined as \\> 450 msec on screening electrocardiogram (EKG) prior to registration\n* COHORT A: Participants must not have relapsed or refractory disease in the bone marrow (≥ 5% blasts) or extramedullary sites involvement\n* COHORT A: Participants must not have systemic fungal, bacterial, viral or other infection that is not controlled (defined as exhibiting ongoing signs\u002Fsymptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment) as determined by the local investigator\n* COHORT A: Participants must not have clinically significant autoimmune disease\n* COHORT A: Participants must be able to take oral medications and comply with the oral regimen Participants must be able to swallow and retain oral medications and have no known gastrointestinal disorders likely to interfere with absorption of oral medications. Administration via nasogastric\u002Fgastrostomy (NG\u002FG)-tube is acceptable as long as oral solution is used\n* COHORT A: Participants must not have uncontrolled intercurrent illness including, but not limited to:\n\n  * Active central nervous system status 3 (CNS3) or CNS2 (CNS leukemia)\n\n    * Note: Participants with CNS1 or who had prior CNS2 or CNS3 are eligible if this has cleared and have become CNS-1\n  * Currently requiring supplemental oxygen (more than 2 liters per minute), mechanical ventilation, vasopressors\n* COHORT A: Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen\n* COHORT A: Participants must not be pregnant or nursing. Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 24 consecutive months or who has semen likely to contain sperm is considered to be of \"reproductive potential.\" In addition to routine contraceptive methods, \"effective contraception\" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation\u002Focclusion, and vasectomy with testing showing no sperm in the semen\n\n  * Note: Participants of childbearing potential must have a negative pregnancy test within 7 days prior to starting treatment\n* COHORT B: Participant must be ≥ 55 years old at the time of registration\n* COHORT B: Participant must have Zubrod\u002FECOG performance status of 0-2\n* COHORT B: Participants must have a complete medical history and physical exam within 28 days prior to registration\n* COHORT B: GFR ≥ 50 ml\u002Fmin\u002F1.73 m\\^2 (within 14 days prior to registration)\n* COHORT B: Direct bilirubin ≤ 2.0 mg\u002FdL (34.2 micromoles\u002FL) (within 14 days prior to registration)\n\n  * Note: Participants with history of Gilbert's disease or elevated bilirubin is related to underlying leukemia must have direct bilirubin ≤ 5 x institutional ULN\n* COHORT B: ALT ≤ 5 x institutional ULN unless abnormal liver tests are related to underlying leukemia (within 14 days prior to registration)\n* COHORT B: Participants must have a calculated creatinine clearance ≥ 50 mL\u002Fmin using the following Cockcroft-Gault formula. This specimen must have been drawn and processed within 14 days prior to registration\n* COHORT B: Participants must have adequate cardiac function. Participants must have cardiac ejection fraction ≥ 50% by MUGA or 2-D echocardiogram within 28 days prior to registration. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants must be class 2B or better\n* COHORT B: Participants with a known history human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load test on the most recent test results obtained within 6 months prior to registration\n* COHORT B: Participants with a known history of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to registration, if indicated\n* COHORT B: Participants with a known history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 6 months prior to registration, if indicated\n* COHORT B: Participants must have a lumbar puncture to determine CNS involvement of ALL within 14 days prior to registration. Intrathecal cytarabine and\u002For methotrexate administered prior to study registration may count as the first dose of intrathecal therapy required as part of protocol therapy\n* COHORT B: Participants must not have an active uncontrolled infection\n* COHORT B: Participants must not have prolonged QTcf defined as \\> 450 msec participants on screening EKG prior to registration\n* COHORT B: Participants must not have known clinical signs of bulk central nervous system involvement (CNS3c), such as facial palsy, brain\u002Feye involvement or hypothalamic syndrome\n* COHORT B: Participants must be able to take oral medications and comply with the oral regimen Participants must be able to swallow and retain oral medications and have no known gastrointestinal disorders likely to interfere with absorption of oral medications. Administration via NG\u002FG-tube is acceptable as long as oral solution is used\n* COHORT B: Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen\n* COHORT B: Participants must not be pregnant or nursing. Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 24 consecutive months or who has semen likely to contain sperm is considered to be of \"reproductive potential.\" In addition to routine contraceptive methods, \"effective contraception\" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation\u002Focclusion, and vasectomy with testing showing no sperm in the semen\n\n  * Note: Participants of childbearing potential must have a negative pregnancy test within 7 days prior to starting treatment\n* ALL COHORTS: Participants must be offered the opportunity to participate in specimen collection submitted for translational medicine work. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (SWOG) Specimen Tracking System\n* NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system\n\n  * Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines\n  * For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations\n  * This trial will use a slot reservation system to enroll the feasibility and safety run-in portions of the study for Cohort A and Cohort B. Patients planning to enroll at this portion of the study must first have a slot reserved in advance of the registration. All site staff will use OPEN to create a slot reservation","1 Year",{"count":87,"type":20},90,[23],"This phase II trial tests how well adding revumenib to usual treatment (blinatumomab) compared to usual treatment alone works in treating patients with B-cell acute lymphoblastic leukemia (B-ALL) or acute leukemia with ambiguous lineage (ALAL) with KMT2A-translocation. Revumenib binds to a protein called menin and keeps it from binding to another protein called KMT2A. This stops or slows the growth of leukemia cells with changes in the KMT2A gene. Blinatumomab binds to CD19, which is found on most B cells (a type of white blood cell) and some types of leukemia cells. It also binds to a protein called CD3, which is found on T cells (another type of white blood cell). This may help the immune system kill cancer cells. In addition to blinatumomab, usual treatment also includes dexamethasone, methotrexate, cyclophosphamide, cytarabine, mercaptopurine, calaspargase pegol, doxorubicin, thioguanine, daunorubicin, vincristine and leucovorin. Dexamethasone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Methotrexate is in a class of medications called antimetabolites. It is also a type of antifolate. Methotrexate stops cells from using folic acid to make deoxyribonucleic acid (DNA) and may kill cancer cells. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill cancer cells. It may also lower the body's immune response. Chemotherapy drugs, such as cytarabine, mercaptopurine, calaspargase pegol, doxorubicin, thioguanine, and daunorubicin, 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. Vincristine is in a class of medications called vinca alkaloids. It works by stopping cancer cells from growing and dividing and may kill them. Leucovorin is also being studied in the treatment of cancer. It is a type of chemoprotective agent and a type of chemosensitizing agent. Adding revumenib to usual treatment with blinatumomab may be safe, tolerable and more effective than blinatumomab alone in lowering the amount of leukemia in patients with B-ALL or ALAL with the KMT2A translocation.",[26,27,91,92],"B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative","T Acute Lymphoblastic Leukemia","NOT_YET_RECRUITING","2026-06-03",{"date":96,"type":32},"2026-06-09",{"date":98,"type":20},"2026-10-14",{"date":100,"type":20},"2032-04-16",{"name":102,"class":103},"SWOG Cancer Research Network","NETWORK",{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":111,"sex":16,"minAge":112,"maxAge":113,"enrollmentInfo":114,"targetDuration":4,"studyType":21,"phases":116,"briefSummary":117,"conditions":118,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":141,"locationsCount":142},"100345603","phase-2-naive-t-cell-depletion-for-preventing-chronic-graft-versus-host-disease-in-children-and-young-adults-with-blood-cancers-undergoing-donor-stem-cell-transplant-100345603","NCT03779854","Naive T Cell Depletion for Preventing Chronic Graft-versus-Host Disease in Children and Young Adults With Blood Cancers Undergoing Donor Stem Cell Transplant","Multi-Center Phase II Randomized Controlled Trial of Naïve T Cell Depletion for Prevention of Chronic Graft-Versus-Host Disease in Children and Young Adults","Inclusion Criteria:\n\n* The patient must have one of the following diagnoses and be considered to be an appropriate candidate for allogeneic HCT by the study site principal investigator (PI):\n\n  * Acute lymphoblastic leukemia (ALL) with \\\u003C 5% marrow blasts.\n  * Acute myeloid leukemia (AML) with \\\u003C 25% marrow blasts.\n  * Other acute leukemia (OAL) or related neoplasm (including but not limited to acute biphenotypic leukemia \\[ABL\\], ambiguous lineage \\[ALAL\\], mixed phenotype acute leukemia \\[MPAL\\], blastic plasmacytoid dendritic cell neoplasm \\[BPDCN\\], acute undifferentiated leukemia \\[AUL\\], lymphoblastic lymphoma, Burkitt leukemia\u002Flymphoma, mast cell leukemia, chronic monocytic leukemia \\[CML\\] with blast crisis or other chronic myeloproliferative neoplasm) with \\\u003C 5% marrow blasts.\n  * Myelodysplastic syndrome (MDS) with excess blasts (EB-1 and EB-2) and has received cytotoxic induction chemotherapy (excluding small molecule inhibitors and de-methylating agents)\n* Age 6 months to 26 years at the time informed consent is obtained using the Informed Consent to Participate in a Research Study form\n* Matched related donor (MRD) or matched unrelated donor (MUD) (defined as 8\u002F8 match for human leukocyte antigen \\[HLA\\]-A, -B, -C, -DRB1).\n* Planned product type for infusion is PBSC or BM (i.e. not cord blood):\n\n  * For feasibility phase, planned product type for infusion must be PBSC.\n  * For RCT, planned product type must be PBSC or BM.\n* Karnofsky or Lansky score \\>= 60%.\n* Left ventricular ejection fraction (LVEF) at rest \\>= 40%.\n* Diffusing capacity of the lungs for carbon monoxide (DLCO) (corrected for hemoglobin) \\>= 60% predicted by pulmonary function tests (PFTs)\n\n  \\* Patients who are unable to perform PFTs (age \\\u003C 6 years or considered developmentally incapable of PFTs): oxygen saturation (by oximetry) must be \\>= 92% on room air.\n* Total bilirubin =\\\u003C 2 x upper limit of normal (ULN) (unless value\\[s\\] \\> 2 x ULN are disease- or medication-related).\n\n  \\* If value(s) are \\> 2 x ULN and not disease- or medication related, patient must be evaluated by a gastrointestinal (GI) physician. If GI physician considers protocol treatment to be contraindicated for the patient, the patient will not be eligible for the study.\n* Alanine aminotransferase (ALT), aspartate aminotransferase (AST) =\\\u003C 2 x ULN (unless value\\[s\\] \\> 2 x ULN are disease- or medication-related).\n\n  \\* If value(s) are \\> 2 x ULN and not disease- or medication related, patient must be evaluated by a gastrointestinal GI physician. If GI physician considers protocol treatment to be contraindicated for the patient, the patient will not be eligible for the study.\n* Serum creatinine (SCr) within normal range for age. If SCr is outside normal range for age, creatinine clearance (CrCl) \\> 40 mL\u002Fmin\u002F1.73m\\^2 must be obtained (measured by 24-hour \\[hr\\] urine specimen or nuclear glomerular filtration rate \\[GFR\\]).\n\n  * Age (Years): Maximum SCr (mg\u002FdL)\n  * =\\\u003C 5: 0.8\n  * 6-10: 1\n  * 11-15: 1.2\n  * \\> 15: 1.5\n* Recipient informed consent\u002Fassent\u002Flegal guardian permission documentation must be obtained.\n* DONOR: May be related (MRD) or unrelated (MUD) to the subject.\n* DONOR: Must be matched to the subject at 8\u002F8 HLA alleles (HLA-A, -B, -C, and -DRB1)\n* DONOR: Be \\>=14 years of age.\n* DONOR: Must be available to donate in the United States of America (USA) (i.e. excludes international donors).\n* DONOR: Must agree to donate BM or PBSC (i.e. agree to donate whichever product type is requested) (applicable only to the RCT phase of this study).\n* DONOR: MUDs:\n\n  * Must give informed consent according to applicable National Marrow Donor Program (NMDP) donor regulatory requirements\n  * Must meet eligibility criteria as defined by the NMDP or be ineligible with statement of urgent medical need (exception 21 CFR 1271.65(b)(iii))\n\n    * Tests must be performed using Food and Drug Administration (FDA) licensed, cleared, and approved test kits in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory\n* DONOR: MRDs:\n\n  * Must be negative for human immunodeficiency virus (HIV)-1, HIV-2, human T-lymphotropic virus (HTLV)-1, HTLV-2, hepatitis B, hepatitis C (serological and\u002For nucleic acid testing \\[NAT\\] and\u002For other approved testing)\n  * Must meet institutional donor eligibility criteria, or be ineligible with statement that the donor is a first or second degree relative (exception 21 CRF 1271.65(b)(i)).\n\n    * Tests must be performed using FDA licensed, cleared, and approved test kits in a CLIA-certified laboratory.\n\nExclusion Criteria:\n\n* Active central nervous system (CNS) disease. A patient may have a history of CNS disease; however, any CNS disease must be cleared by the end of the pre-conditioning evaluation. If CNS disease is identified on the first cerebrospinal fluid (CSF) evaluation within 30 days of the start of the preparative regimen, a repeat CSF evaluation must be performed and show no evidence of disease in order for the patient to be eligible for the protocol.\n* Patients on other experimental protocols for the prevention of GVHD.\n* Patient body weight:\n\n  * Matched related donor (MRD): \\> 100 kg are ineligible\n  * Matched unrelated donor (MUD): \\> 75 kg must be discussed with the protocol principal investigator (PI) prior to enrollment.\n* HIV-positive.\n* Uncontrolled infections must be evaluated by an infectious disease physician and considered suitable to undergo HCT by the study site PI, infectious disease physician and protocol PI. Upper respiratory tract infection (URI) does not constitute an uncontrolled infection in this context.\n* Life expectancy \\\u003C 3 months from disease other than acute leukemia or myelodysplastic syndrome (MDS).\n* Significant medical condition that would make recipient unsuitable for HCT.\n* Prior allogeneic or autologous HCT.\n* Females who are pregnant or breastfeeding.\n* Patients of child bearing age who are presumed to be fertile and are unwilling to use an effective birth control method or refrain from sexual intercourse during study treatment and for 12 months following HCT.\n* Known hypersensitivity to tacrolimus, fludarabine, or methotrexate (MTX).",true,"6 Months","26 Years",{"count":115,"type":20},68,[23],"This phase II trial studies how well naive T-cell depletion works in preventing chronic graft-versus-host disease in children and young adults with blood cancers undergoing donor stem cell transplant. Sometimes the transplanted white blood cells from a donor attack the body's normal tissues (called graft versus host disease). Removing a particular type of T cell (naive T cells) from the donor cells before the transplant may stop this from happening.",[119,120,26,121,122,123,124,125,126,127,128,129,130,131,132,133,134],"Acute Biphenotypic Leukemia","Acute Leukemia","Acute Lymphoblastic Leukemia","Acute Undifferentiated Leukemia","Allogeneic Hematopoietic Stem Cell Transplantation Recipient","Blastic Plasmacytoid Dendritic Cell Neoplasm","Blasts Under 25 Percent of Bone Marrow Nucleated Cells","Blasts Under 5 Percent of Bone Marrow Nucleated Cells","Mixed Phenotype Acute Leukemia","Myelodysplastic Syndrome With Excess Blasts-1","Myelodysplastic Syndrome\u002FAcute Myeloid Leukemia","Burkitt Leukemia","Chronic Monocytic Leukemia","Lymphoblastic Lymphoma","Mast Cell Leukemia","Myeloproliferative Neoplasm","2026-05-11",{"date":137,"type":32},"2026-05-14",{"date":139,"type":32},"2019-08-29",{"date":36,"type":20},{"name":65,"class":66},10,{"id":144,"slug":145,"hasResults":11,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":4,"eligibilityCriteria":149,"healthyVolunteers":11,"sex":16,"minAge":85,"maxAge":150,"enrollmentInfo":151,"targetDuration":4,"studyType":21,"phases":153,"briefSummary":155,"conditions":156,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":142},"100529691","phase-1-study-of-revumenib-azacitidine-and-venetoclax-in-pediatric-and-young-adult-patients-with-refractory-or-relapsed-acute-myeloid-leukemia-100529691","NCT06177067","Study of Revumenib, Azacitidine, and Venetoclax in Pediatric and Young Adult Patients With Refractory or Relapsed Acute Myeloid Leukemia","A Phase 1 Study of Revumenib, Azacitidine, and Venetoclax in Pediatric and Young Adult Patients With Refractory or Relapsed Acute Myeloid Leukemia","Inclusion Criteria: Participants must have a diagnosis of AML or ALAL and meet the criteria below:\n\n* Refractory leukemia, defined as persistent leukemia after at least two courses of induction chemotherapy (one course for secondary AML), or relapsed leukemia, defined as the re-appearance of leukemia after the achievement of remission. Patients must have ≥5% blasts in the bone marrow as assessed by morphology or ≥1% blasts flow cytometry.\n\nHowever, if an adequate bone marrow sample cannot be obtained (e.g., in a patient with acute megakaryoblastic leukemia with marrow fibrosis), patients may be enrolled if there is unequivocal evidence of leukemia with ≥5% blasts by morphology or ≥1% blasts flow cytometry in the blood.\n\n* Presence of KMT2A rearrangement (KMT2Ar), NUP98 rearrangement (NUP98r), NPM1 mutation or fusion, PICALM::MLLT10, DEK::NUP214, UBTF-TD, KAT6A rearrangement (KAT6Ar), or SET::NUP214\n* Adequate organ function, defined as total bilirubin \\\u003C 1.5 × institutional upper limit of normal for age or normal conjugated bilirubin (for patients with known Gilbert's syndrome, total bilirubin \\\u003C3 × the ULN) unless attributed to leukemia, calculated creatinine clearance ≥60 mL\u002Fmin\u002F1.73 m\\^2, and left ventricular ejection fraction ≥ 40%\n* QTcF \\\u003C 480 msec (average of triplicate)\n* Age ≥ 1 year and ≤ 30 years. The upper age limit may be defined by each institution, but may not exceed 30 years.\n* Lansky ≥ 60 for patients who are \\\u003C 16 years old and Karnofsky ≥ 60% for patients who are \\> 16 years old.\n* At least 14 days or 5 half-lives (whichever is longer) must have elapsed since the completion of myelosuppressive therapy, with the exception of low-dose therapy used for cytoreduction according to institutional standards, such as hydroxyurea or low-dose cytarabine (up to 200 mg\u002Fm\\^2\u002Fday). In addition, all toxicities must have resolved to grade 1 or less.\n* Patients must have a leukocyte count \\\u003C25,000 cells\u002FuL. Low-dose therapy, such as hydroxyurea or cytarabine as described above, to achieve this limit is acceptable.\n* For patients who have received prior HCT, there can be no evidence of GVHD and greater than 60 days must have elapsed since the HCT, and patients should be off calcineurin inhibitors for at least 28 days prior to the start of protocol therapy. Physiologic prednisone for the treatment of adrenal insufficiency is acceptable..\n* Patients must be taking posaconazole or voriconazole, which must be started at least 24 hours prior to the start of therapy.\n* Patients of reproductive potential must agree to use effective contraception for the duration of study participation.\n\nPatients who meet the criteria listed above are eligible for enrollment and treatment on the trial. However, patients in first relapse who are suitable for and willing to receive intensive remission induction therapy should be offered such therapy if deemed appropriate by the treating physician.\n\nExclusion Criteria:\n\n* Patients who are pregnant or breastfeeding are not eligible.\n* Patients with Down syndrome, acute promyelocytic leukemia, juvenile myelomonocytic leukemia, or bone marrow failure syndromes are not eligible.\n* Patients with uncontrolled infection are not eligible. Patients with infections that are controlled on concurrent anti-microbial agents are eligible.","30 Years",{"count":152,"type":20},24,[154],"PHASE1","This is a research study to find out if adding a new study drug called revumenib to commonly used chemotherapy drugs is safe and if they have beneficial effects in treating patients with acute myeloid leukemia (AML) or acute leukemia of ambiguous lineage (ALAL) that did not go into remission after treatment (refractory) or has come back after treatment (relapsed), and to determine the total dose of the 3-drug combination of revumenib, azacitidine and venetoclax that can be given safely in participants also taking an anti-fungal drug.\n\nPrimary Objective\n\n* To determine the safety and tolerability of revumenib + azacitidine + venetoclax in pediatric patients with relapsed or refractory AML or ALAL.\n\nSecondary Objectives\n\n* Describe the rates of complete remission (CR), complete remission with incomplete count recovery (CRi), and overall survival for patients treated with revumenib + azacitidine + venetoclax at the recommended phase 2 dose (RP2D).",[157,158,26],"Refractory Acute Myeloid Leukemia","Relapsed Acute Myeloid Leukemia","2026-05-01",{"date":161,"type":32},"2026-05-04",{"date":163,"type":32},"2024-04-19",{"date":165,"type":20},"2027-04",{"name":167,"class":66},"St. Jude Children's Research Hospital",{"id":169,"slug":170,"hasResults":11,"nctId":171,"briefTitle":172,"officialTitle":173,"acronym":174,"eligibilityCriteria":175,"healthyVolunteers":11,"sex":16,"minAge":176,"maxAge":4,"enrollmentInfo":177,"targetDuration":4,"studyType":21,"phases":179,"briefSummary":180,"conditions":181,"keywords":183,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":203},"100367524","phase-1-a-study-of-revumenib-in-rr-leukemias-including-those-with-an-mllkmt2a-gene-rearrangement-or-npm1-mutation-100367524","NCT04065399","A Study of Revumenib in R\u002FR Leukemias Including Those With an MLL\u002FKMT2A Gene Rearrangement or NPM1 Mutation","A Phase 1\u002F2, Open-label, Dose-Escalation and Dose-Expansion Cohort Study of SNDX-5613 in Patients With Relapsed\u002FRefractory Leukemias, Including Those Harboring an MLL\u002FKMT2A Gene Rearrangement or Nucleophosmin 1 (NPM1) Mutation","AUGMENT-101","Key Inclusion Criteria:\n\nParticipants must have active acute leukemia (bone marrow blasts ≥5% or reappearance of blasts in peripheral blood) as defined by the National Comprehensive Cancer Network (NCCN) in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Acute Lymphoblastic Leukemia (Version 1.2020) and Acute Myeloid Leukemia (Version 3.2020), or acute leukemia harboring KMT2A rearrangement, NUP98 rearrangement, or NPM1 mutation that have detectable disease in the bone marrow.\n\n1. Phase 1:\n\n   * Arm A: Participants not receiving any strong CYP3A4 inhibitor\u002Finducers or fluconazole.\n   * Arm B: Participants receiving itraconazole, ketoconazole, posaconazole, or voriconazole (strong CYP3A4 inhibitors) for antifungal prophylaxis.\n   * Arm C: Participants receiving revumenib in combination with cobicistat.\n   * Arm D: Participants receiving fluconazole (moderate CYP3A4 inhibitor).\n   * Arm E: Participants not receiving any weak, moderate, or strong CYP3A4 inhibitors\u002Finducers.\n   * Arm F: Participants receiving isavuconazole (moderate CYP3A4 inhibitor) for antifungal prophylaxis.\n2. Phase 2:\n\n   Documented R\u002FR active acute leukemia (bone marrow blasts ≥5% or reappearance of blasts in peripheral blood) as defined by the NCCN Guidelines® for Acute Lymphoblastic Leukemia (Version 1.2020) and Acute Myeloid Leukemia (Version 3.2020).\n   * Cohort 2A: Documented R\u002FR ALL\u002FMPAL with KMT2A rearrangement.\n   * Cohort 2B: Documented R\u002FR AML with KMT2A rearrangement.\n   * Cohort 2C: Documented R\u002FR AML with NPM1m.\n   * Cohort 2D: Documented R\u002FR acute leukemia with a genetic mutation expected to lead to HOX\u002FMEIS upregulation (for example, KMT2Ar, NPM1m, and NUP98r), including participants who are MRD-positive by multiparametric flow cytometry or molecular methods only, and including participants with isolated extramedullary disease.\n3. White blood cell count below 25,000\u002F microliter at time of enrollment. Participants may receive cytoreduction prior to enrollment per protocol-specified criteria.\n4. Male or female participants aged ≥30 days old. Participants intended to receive SNDX-5613 in combination with cobicistat must weigh ≥35 kilograms (kg). Participants in Cohort 2D must be ≥18 years of age and have a body weight ≥40 kg.\n5. Eastern Cooperative Oncology Group (ECOG) performance status score 0-2 or Karnofsky\u002FLansky score ≥50.\n6. Any prior treatment-related toxicities resolved to ≤Grade 1 prior to enrollment, with the exception of ≤Grade 2 neuropathy or alopecia.\n\n   Phase 1 and Phase 2 Cohorts 2A-2C only:\n7. Radiation Therapy: At least 60 days from prior total body irradiation (TBI), craniospinal radiation and\u002For ≥50% radiation of the pelvis, or at least 14 days from local palliative radiation therapy (small port).\n8. Stem Cell Infusion: At least 60 days must have elapsed from hematopoietic stem cell transplant and at least 4 weeks must have elapsed from donor lymphocyte infusion.\n9. Immunotherapy: At least 42 days since prior immunotherapy, including tumor vaccines, and at least 21 days since receipt of chimeric antigen receptor therapy or other modified T or NK cell therapy.\n10. Antileukemia Therapy: At least 14 days, or 5 half-lives, whichever is shorter, since the completion of antileukemic therapy.\n11. Hematopoietic Growth Factors: At least 7 days since the completion of therapy with short-acting hematopoietic growth factors and 14 days with long-acting growth factors.\n12. Biologics: At least 90 days, or 5 half-lives, whichever is shorter, since the completion of therapy with an antineoplastic biologic agent.\n13. Steroids: At least 7 days since systemic glucocorticoid therapy, unless receiving physiologic dosing or cytoreductive therapy.\n\n    Phase 2 Cohort 2D only:\n\n    At least 14 days since any other investigational or commercially available antileukemic therapy, with the following exceptions:\n    1. Cytoreductive therapy with hydroxyurea, low-dose cytarabine (20 mg\u002Fsquare meter (m\\^2)\u002Fday subcutaneously \\[SC\\] for 10 days) or low-dose etoposide (up to 200 mg\u002Fday orally for 10 days) may be administered concurrently with SNDX-5613.\n    2. Intrathecal chemotherapy for CNS prophylaxis is permitted at the treating physician's discretion.\n    3. Steroids at physiologic dosing (equivalent to ≤10 mg prednisone daily for participants ≥18 years or ≤10 mg\u002Fm\\^2\u002Fday for participants \\\u003C18 years) or for cytoreductive therapy.\n14. Adequate organ function.\n15. If of childbearing potential, willing to use a highly effective method of contraception from the time of enrollment through 120 days following the last study drug dose.\n\nKey Exclusion Criteria:\n\nParticipants meeting any of the following criteria are not eligible for study participation:\n\n1. Diagnosis of active acute promyelocytic leukemia.\n2. Isolated extramedullary relapse (Phase 2 Cohorts 2A-2C only).\n3. Active central nervous system disease (cytologic, such as any blasts on cytospin, or radiographic).\n4. Detectable human immunodeficiency virus (HIV) viral load within the previous 6 months. Participants with a known history of HIV 1\u002F2 antibodies must have viral load testing prior to study enrollment.\n5. Hepatitis B or C.\n6. Pregnant or nursing women.\n7. Cardiac Disease:\n\n   * Any of the following within the 6 months prior to study entry: myocardial infarction, uncontrolled\u002Funstable angina, congestive heart failure (New York Heart Association Classification Class ≥II), life-threatening, uncontrolled arrhythmia, cerebrovascular accident, or transient ischemic attack.\n   * Corrected QT interval (QTc) \\>450 milliseconds.\n8. Gastrointestinal Disease:\n\n   * any gastrointestinal issue of the upper GI tract that might affect oral drug absorption or ingestion (that is, gastric bypass and gastroparesis).\n   * Cirrhosis with a Child-Pugh score of B or C.\n9. Graft-Versus-Host Disease (GVHD): Signs or symptoms of acute or chronic GVHD \\>Grade 0 within 4 weeks of enrollment. All transplant participants must have been off all systemic immunosuppressive therapy and calcineurin inhibitors for at least 4 weeks prior to enrollment. Participants may be on physiological doses of steroids.\n10. Concurrent malignancy in the previous 2 years with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (for example, breast carcinoma, cervical cancer in situ, melanoma in situ) treated with potentially curative therapy, or concurrent low-grade lymphoma, that is asymptomatic and lacks bulky disease and shows no evidence of progression, and for which the participant is not receiving any systemic therapy or radiation.\n11. In Phase 1 and Phase 2: Participants requiring the concurrent use of medications known or suspected to prolong the QT\u002FQTc interval, with the exception of drugs with low risk of QT\u002FQTc prolongation that are used as standard supportive therapies (for example, diphenhydramine, famotidine, ondansetron, Bactrim) and the azoles permitted in the relevant arms of Phase 1 and in Phase 2.\n\nNote: Other protocol defined inclusion\u002Fexclusion criteria may apply.","30 Days",{"count":178,"type":20},447,[154,23],"Phase 1 dose escalation will determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of revumenib in participants with acute leukemia.\n\nIn Phase 2, participants will be enrolled in 4 indication-specific expansion cohorts to determine the efficacy, short- and long-term safety, and tolerability of revumenib.",[55,121,182,127,26],"Mixed Lineage Acute Leukemia",[184,16,185,186,187,188,189,190,191,192],"AML","MPAL","MLAL","ALAL","relapsed leukemia","refractory leukemia","acute leukemia","KMT2A","NPM1","2026-03-17",{"date":195,"type":32},"2026-03-18",{"date":197,"type":32},"2019-11-05",{"date":199,"type":20},"2027-12-15",{"name":201,"class":202},"Syndax Pharmaceuticals","INDUSTRY",57,{"id":205,"slug":206,"hasResults":11,"nctId":207,"briefTitle":208,"officialTitle":209,"acronym":4,"eligibilityCriteria":210,"healthyVolunteers":11,"sex":16,"minAge":85,"maxAge":211,"enrollmentInfo":212,"targetDuration":4,"studyType":21,"phases":214,"briefSummary":215,"conditions":216,"keywords":227,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":236,"lastUpdatePostDateStruct":237,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":243,"locationsCount":245},"100461746","phase-1-venetoclax-basket-trial-for-high-risk-hematologic-malignancies-100461746","NCT05292664","Venetoclax Basket Trial for High Risk Hematologic Malignancies","A Phase I Study of Venetoclax in Combination With Cytotoxic Chemotherapy, Including Calaspargase Pegol, for Children, Adolescents and Young Adults With High-Risk Hematologic Malignancies","Inclusion Criteria\n\nCohort A Inclusion Criteria:\n\n* MDS, AML arising from MDS (MDS\u002FAML), therapy related myeloid neoplasm (tMDS\u002FAML) meeting at least one of the following criteria:\n\n  * MDS with excess blasts (\\>10%)\n  * MDS with blasts \\\u003C10% with high-risk features\n  * MDS refractory to initial treatment\n  * Relapsed MDS\n  * MDS\u002FAML: May be newly diagnosed or relapsed\u002Frefractory disease.\n  * Therapy related myeloid neoplasm (tMDS\u002FAML): May be initial or relapsed\u002Frefractory disease.\n\n    * Note: MDS or MDS\u002FAML may be derived from a germline predisposition to myeloid malignancy as long as that condition does not confer increased toxicity to treatment.\n* Age ≤ 40 years of age, except the following subjects that must be \\\u003C18 years to enroll\n\n  * Subjects with MDS\u002FAML that have not received prior therapy\n  * Subjects enrolled onto Dose level -2.\n* Lansky\u002FKarnofsky performance status ≥ 50%\n* Participants must have fully recovered from the acute toxic effects of all and meet all of the following criteria:\n\n  * Myelosuppressive chemotherapy: 14 days, or 5 half-lifes (whichever is shorter) must have elapsed since the completion of myelosuppressive therapy. Individuals may have received any of the following medications without a \"wash-out\" period\n\n    * Standard maintenance therapy: dexamethasone\u002Fprednisone, vincristine, 6MP, low dose methotrexate)\n    * Hydroxyurea\n    * Intrathecal chemotherapy with methotrexate, hydrocortisone and\u002For cytarabine.\n  * Radiation therapy (XRT):\n\n    * Total Body Irradiation (TBI) or cranial radiation therapy: Must have been completed more than 90 days prior to study entry\n    * XRT for chloroma does not require a washout period.\n    * Palliative XRT does not require a washout\n  * Small molecule inhibitors (BCR-ABL or FLT3 inhibitors, for example): 7 days, or 5 half-lifes, whichever is shorter) must have elapsed since the completion of therapy. For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur.\n  * Immunotherapy: At least 30 days after the administration of any type of immunotherapy, including, but not limited to, tumor vaccines, chimeric antigen receptor (CAR) therapy, other immune effector cell therapy and checkpoint inhibitors.\n  * Monoclonal antibodies: At least 3 half-lives of the antibody\n  * Prior hematopoietic stem cell transplant (HSCT):\n\n    * Allogeneic HSCT \\> 90 days of study entry\n    * No evidence of graft-versus-host-disease (GVHD)\n  * Adequate organ function, as defined by\n\n    * Serum alanine aminotransferase (ALT) ≤5X upper limit of normal (ULN)\n    * Direct bilirubin ≤ 3X\n    * Ejection fraction ≥ 50% or shortening fraction of ≥ 24% on screening echocardiogram.\n  * Female participants of childbearing potential must have a negative urine or serum HCG prior to study entry and at the start of therapy. All females of childbearing potential must refrain from breastfeeding during study participation, and all male and females of childbearing potential must agree to use an effective form of contraception (abstinence, hormonal, or barrier) prior to study entry, for duration of participation, and for a minimum of 30 days following the last dose of treatment.\n\nCohort B Inclusion Criteria\n\n* MDS, MDS\u002FAML, therapy related myeloid neoplasm (tMDS\u002FAML) that is derived from the following germline disorders:\n\n  * Dyskeratosis Congenita or associated telomeropathies\n  * Fanconi Anemia\n  * Nijmegen Breakage\n  * Other related disorders with high risk of toxicity may be eligible for this cohort after discussion with the Sponsor-Investigator.\n* And meets at least one the following disease characteristics:\n\n  * MDS with excess blasts (\\>10%)\n  * MDS with blasts \\\u003C10% with high-risk features\n  * MDS refractory to initial treatment\n  * Relapsed MDS\n  * MDS\u002FAML: May be newly diagnosed or relapsed\u002Frefractory disease.\n  * Therapy related myeloid neoplasm (tMDS\u002FAML): May be initial or relapsed\u002Frefractory disease.\n* Age ≤ 40 years of age\n* Lansky\u002FKarnofsky performance status ≥ 50%\n* Participants must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study and meet all of the following criteria:\n\n  * Myelosuppressive chemotherapy: 14 days, or 5 half-lifes (which ever is shorter) must have elapsed since the completion of myelosuppressive therapy. Individuals may have received any of the following medications without a \"wash-out\" period\n\n    * Standard maintenance therapy: dexamethasone\u002Fprednisone, vincristine, 6MP, low dose methotrexate\n    * Hydroxyurea\n    * Intrathecal chemotherapy with methotrexate, hydrocortisone and\u002For cytarabine.\n  * Radiation therapy (XRT):\n\n    * Total Body Irradiation (TBI) or cranial radiation therapy: Must have been completed more than 90 days prior to study entry\n    * XRT for chloroma does not require a washout period.\n    * Palliative XRT does not require a washout\n  * Small molecule inhibitors (BCR-ABL or FLT3 inhibitors, for example): 7 days, or 5 half-lifes, whichever is shorter) must have elapsed since the completion of therapy. For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur.\n  * Immunotherapy: At least 30 days after the administration of any type of immunotherapy, including, but not limited to, tumor vaccines, chimeric antigen receptor (CAR) therapy, other immune effector cell therapy and checkpoint inhibitors.\n  * Monoclonal antibodies: At least 3 half-lives of the antibody\n  * Prior hematopoietic stem cell transplant (HSCT): Must meet all of the following conditions:\n\n    * Allogeneic HSCT \\> 90 days of study entry\n    * No evidence of graft-versus-host-disease (GVHD)\n* Adequate organ function, as defined by\n\n  * Serum alanine aminotransferase (ALT) ≤5X upper limit of normal (ULN)\n  * Direct bilirubin ≤ 3X upper limit of normal for age and institution.\n* Ejection fraction ≥ 50% or shortening fraction of ≥ 24% on screening echocardiogram.\n* Because of the teratogenic effects of venetoclax on developing fetuses, female participants of childbearing potential must have a negative urine or serum HCG prior to study entry and at the start of therapy. All females of childbearing potential must refrain from breastfeeding during study participation, and all male and females of childbearing potential must agree to use an effective form of contraception (abstinence, hormonal, or barrier) prior to study entry, for duration of participation, and for a minimum of 30 days following the last dose of treatment.\n\nCohort C Inclusion Criteria\n\n* Part I: B-cell or T-cell acute lymphoblastic leukemia (ALL), mixed phenotype acute lymphoblastic leukemia (MPAL) or lymphoblastic lymphoma (LBL) in first or greater relapse or refractory to at least 1 prior remission induction attempt.\n\n  * For ALL\u002FMPAL: Bone marrow involvement ≥ 5% by aspirate morphology or ≥ 1% assessable by flow cytometry or validated molecular minimal residual disease (MRD) testing\n  * For LBL: Radiographically detectable mass or lymph node involvement\n* Part II: Histologically confirmed diagnosis of one of the following:\n\n  * T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LBL) in first or greater relapse or refractory to at least 1 prior remission induction attempt.\n\n    * For T-ALL: Bone marrow involvement ≥ 5% by aspirate morphology or ≥ 1% assessable by morphology, flow cytometry or validated MRD testing\n    * For T-LBL (biopsy proven at current or prior relapse): Radiographically detectable mass or lymph node involvement OR\n  * Relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL) with bone marrow involvement ≥1% (assessable by morphology, flow cytometry or validated MRD testing) and at least one of the following characteristics:\n\n    * First relapse with adverse biologic determinants as described below:\n\n      * KMT2A rearrangement\n      * Low hypodiploidy, defined as ≤ 40 chromosomes\n      * t(17;19)\n      * IKZF1 deletion (without targetable ABL1 fusion)\n      * Ph-like ALL (without targetable ABL1 fusion)\n      * Other biologic determinants with adverse prognosis in discussion with the Sponsor-Investigator\n    * Early first bone marrow relapse occurring \\\u003C36 months from initial diagnosis\n    * Primary refractory ALL that has failed 1 prior induction attempt\n* Age: ≥ 1 and ≤ 21 years of age\n* Lansky\u002FKarnofsky performance status ≥ 50%\n* Participants must have fully recovered from the acute toxic effects of all prior and meet all of the following criteria:\n\n  * Myelosuppressive chemotherapy: 14 days, or 5 half-lives, whichever is shorter, must have elapsed since the completion of myelosuppressive therapy. Individuals may have received any of the following medications without a \"wash-out\" period:\n\n    * Standard maintenance therapy: dexamethasone\u002Fprednisone, vincristine, 6MP, low dose methotrexate\n    * Hydroxyurea\n    * Intrathecal chemotherapy with methotrexate, hydrocortisone and\u002For cytarabine.\n  * Radiation therapy (XRT):\n\n    * Total Body Irradiation (TBI) or cranial radiation therapy: Must have been completed more than 90 days prior to study entry\n    * XRT for chloroma does not require a washout period.\n    * Palliative XRT does not require a washout\n  * Small molecule inhibitors (BCR-ABL or FLT3 inhibitors, for example): 7 days, or 5 half-lifes, whichever is shorter) must have elapsed since the completion of therapy. For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur.\n  * Immunotherapy: At least 30 days after the administration of any type of immunotherapy, including, but not limited to, tumor vaccines, chimeric antigen receptor (CAR) therapy, other immune effector cell therapy and checkpoint inhibitors.\n  * Monoclonal antibodies: At least 3 half-lives of the antibody after the last dose of a monoclonal antibody\n  * Prior hematopoietic stem cell transplant (HSCT): Patients who have received HSCT are eligible, but must meet all of the following conditions:\n\n    * Allogeneic HSCT \\> 90 days of study entry\n    * No evidence of graft-versus-host-disease (GVHD)\n* Adequate organ function, as defined by the following laboratory values:\n\n  * Serum alanine aminotransferase (ALT) ≤5X upper limit of normal (ULN), unless deemed secondary to leukemic involvement in discussion with site PI.)\n  * Direct bilirubin ≤ 3X upper limit of normal for age and institution.\n  * Serum amylase ≤ 3X institutional ULN .\n* Cardiac function as defined as below:\n\n  * Ejection fraction ≥ 50% or shortening fraction of ≥ 24% on screening echocardiogram.\n  * Maximum prior cumulative doxorubicin dose ≤ 360 mg\u002Fm2 or equivalent\n* Because of the teratogenic effects of venetoclax on developing fetuses, female participants of childbearing potential must have a negative urine or serum HCG prior to study entry and at the start of therapy. All females of childbearing potential must refrain from breastfeeding during study participation, and all male and females of childbearing potential must agree to use an effective non-hormonal form of contraception (abstinence, barrier) prior to study entry, for duration of participation, and for a minimum of 3 months following the last dose of treatment (as calaspargase pegol can render hormonal contraceptives ineffective).\n\nExclusion Criteria\n\nCohort A Exclusion Criteria\n\n* Use of strong or moderate CYP3A inhibitors\u002Finducers within 3 days of study entry\n* Individuals who have had a stem cell transplant and are still receiving treatment for GVHD or GVHD prophylaxis, or who have evidence of acute GVHD\n* Individuals with known active hepatitis; baseline testing not required.\n* Patients with systemic infection that is exhibiting ongoing signs\u002Fsymptoms related to the infection without improvement despite appropriate antibiotics or other treatment.\n* Patients known to have human immunodeficiency virus (HIV) infection; baseline testing for HIV is not required.\n* Pregnant or nursing women are excluded.\n* Individuals with significant concurrent disease, illness, psychiatric disorder or social issue that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results.\n\nCohort B Exclusion Criteria\n\n* Use of strong or moderate CYP3A inhibitors\u002Finducers within 3 days of study entry\n* Individuals who have had a stem cell transplant and are still receiving treatment for GVHD or GVHD prophylaxis, or who have evidence of acute GVHD\n* Individuals with known active hepatitis; baseline testing not required.\n* Patients with systemic infection that is exhibiting ongoing signs\u002Fsymptoms related to the infection without improvement despite appropriate antibiotics or other treatment.\n* Patients known to have human immunodeficiency virus (HIV) infection; baseline testing for HIV is not required.\n* Pregnant or nursing women are excluded.\n* Individuals with significant concurrent disease, illness, psychiatric disorder or social issue that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results.\n\nCohort C Exclusion Criteria\n\n* Use of strong or moderate CYP3A inhibitors\u002Finducers within 3 days of study entry\n* Individuals who have had a stem cell transplant and are still receiving treatment for GVHD or GVHD prophylaxis, or who have evidence of acute GVHD, or who are less than 90 days from stem cell infusion\n* Individuals with known active hepatitis; baseline testing not required.\n* Patients with systemic fungal, bacterial, viral or other infection that is exhibiting ongoing signs\u002Fsymptoms related to the infection without improvement despite appropriate antibiotics or other treatment.\n* Patients known to have human immunodeficiency virus (HIV) infection; baseline testing for HIV is not required.\n* Pregnant or nursing women are excluded\n* Individuals with significant concurrent disease, illness, psychiatric disorder or social issue that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results.\n* Individuals with a history of allergic reactions to any of the agents being used in this trial, with the exception of pegaspargase or calaspargase pegol. Participants with a history of allergy to pegylated formulation of asparasginase are allowed on study but should receive commercial supply of asparaginase Erwinia chrysanthemi (Erwinaze), crisantaspase (Erwinase), or asparaginase erwinia chrysanthemi (recombinant)-rywn (Rylaze) instead of calaspargase pegol (see Sections 6.2.6 and 6.2.7). Individuals with a history of allergy to Erwinaze, Erwinase or Rylaze are excluded from the study.\n* History of asparaginase-associated pancreatitis.\n* Known, active and propagating deep venous thrombus (DVT).\n* Individuals with isolated CNS or testicular relapse.\n* Presence of surface immunoglobulin by flow cytometry and\u002For known t(8;14), t(2;8), or t(8;22).\n* Individuals with a history of a different malignancy are ineligible except for the following circumstances:\n\n  * Individuals are eligible if they have been disease-free for at least 1 year and are deemed by the investigator to be at low risk for recurrence of that malignancy.\n  * Individuals with the following cancers are eligible if diagnosed and treated within the past year: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin.","40 Years",{"count":213,"type":20},30,[154],"This trial is evaluating the safety and tolerability of venetoclax with chemotherapy in pediatric and young adult patients with hematologic malignancies, including myelodysplastic syndrome (MDS), acute myeloid leukemia derived from myelodysplastic syndrome (MDS\u002FAML), and acute lymphoblastic leukemia (ALL)\u002Flymphoblastic lymphoma (LBL).\n\nThe names of the study drugs involved in this study are below. Please note this is a list for the study as a whole, participants will receive drugs according to disease cohort.\n\n* Venetoclax\n* Azacitidine\n* Cytarabine\n* Methotrexate\n* Hydrocortisone\n* Leucovorin\n* Dexamethasone\n* Vincristine\n* Doxorubicin\n* Dexrazoxane\n* Calaspargase pegol\n* Hydrocortisone",[217,218,219,220,221,222,223,224,225,226,26],"Myelodysplastic Syndromes, de Novo","Myelodysplastic Syndromes, Secondary","Myelodysplastic Syndromes, Previously Treated","Treatment-Related Acute Myeloid Leukemia","Therapy-Related Myelodysplastic Syndrome","Acute Lymphoblastic Leukemia, in Relapse","Acute Lymphoblastic Leukemia With Failed Remission","Lymphoblastic Lymphoma, in Relapse","Lymphoblastic Lymphoma, Refractory","Acute Leukemia of Ambiguous Lineage in Relapse",[228,229,230,231,232,233,234,235],"Myelodysplastic Syndrome (MDS)","Treatment-related Acute Myelogenous Leukemia","AML arising from MDS","Relapsed or Refractory Acute Lymphoblastic Leukemia","Relapsed or Refractory Acute Lymphoblastic Lymphoma","Relapsed or Refractory MDS","Treatment-related MDS","Relapsed or Refractory Acute leukemia of ambiguous lineage","2026-03-10",{"date":238,"type":32},"2026-03-12",{"date":240,"type":32},"2023-03-29",{"date":242,"type":20},"2030-07-02",{"name":244,"class":66},"Andrew E. Place, MD",5,{"id":247,"slug":248,"hasResults":11,"nctId":249,"briefTitle":250,"officialTitle":251,"acronym":4,"eligibilityCriteria":252,"healthyVolunteers":11,"sex":16,"minAge":253,"maxAge":4,"enrollmentInfo":254,"targetDuration":4,"studyType":21,"phases":256,"briefSummary":257,"conditions":258,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":263,"lastUpdatePostDateStruct":264,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"locationsCount":67},"100560296","phase-1-revumenib-for-the-treatment-of-acute-leukemia-in-patients-post-allogeneic-stem-cell-transplant-100560296","NCT06575296","Revumenib for the Treatment of Acute Leukemia in Patients Post-Allogeneic Stem Cell Transplant","A Phase I Study of SNDX 5613 (Revumenib) as Post-Transplant Maintenance After Allogeneic Hematopoietic Cell Transplant in Patients With KMT2A-Rearranged or NPM1-Mutated Acute Leukemia","Inclusion Criteria:\n\n* PATIENTS WHO ARE SCHEDULED TO UNDERGO HEMATOPOIETIC CELL TRANSPLANTATION (HCT) OR THOSE WHO HAVE UNDERGONE HCT: Documented informed consent of the participant and\u002For legally authorized representative\n* PATIENTS WHO ARE SCHEDULED TO UNDERGO HCT OR THOSE WHO HAVE UNDERGONE HCT: Agreement to allow the use of archival tissue from diagnostic tumor biopsies; if unavailable, exceptions may be granted with study principal investigator (PI) approval\n* PATIENTS WHO ARE SCHEDULED TO UNDERGO HCT OR THOSE WHO HAVE UNDERGONE HCT: Participant is willing and able to adhere to the study visit schedule and other protocol requirements\n* PATIENTS WHO ARE SCHEDULED TO UNDERGO HCT OR THOSE WHO HAVE UNDERGONE HCT: Age: \\>= 2 years\n* PATIENTS WHO ARE SCHEDULED TO UNDERGO HCT OR THOSE WHO HAVE UNDERGONE HCT: Have a date for transplant within the next 4 weeks or have received transplant within the last 4 months\n* PATIENTS WHO ARE SCHEDULED TO UNDERGO HCT OR THOSE WHO HAVE UNDERGONE HCT: Participant was diagnosed with an acute leukemia as defined by the World Health Organization (WHO) 5th edition criteria for acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), or acute leukemia with ambiguous lineage\n* PATIENTS WHO ARE SCHEDULED TO UNDERGO HCT OR THOSE WHO HAVE UNDERGONE HCT: Participant must meet one of the following disease characteristics:\n\n  * Confirmed NPM1m AML with at least one of the following additional characteristics\n\n    * FLT3-ITD co-mutation\n    * Pre-transplant MRD+ disease by flow cytometry or real time polymerase chain reaction (qPCR)\n    * Requires more than one AML induction regimen to acquire complete response (CR)1\n    * In second or later complete remission\n  * Confirmed KMT2Ar acute leukemia obtained by fluorescence in situ hybridization (11q23 MLL-break apart fluorescence in situ hybridization \\[FISH\\]) or next-generation sequencing (NGS)\n* PATIENTS WHO ARE SCHEDULED TO UNDERGO HCT OR THOSE WHO HAVE UNDERGONE HCT: Any donor (sibling, unrelated, mismatched related\u002Funrelated, cord and haploidentical) or graft source (peripheral blood \\[PB\\] stem cell or bone marrow \\[BM\\]) will be included\n* PATIENTS WHO ARE SCHEDULED TO UNDERGO HCT OR THOSE WHO HAVE UNDERGONE HCT: Conditioning regimen: investigator's choice based on center guidelines\n* PATIENTS WHO ARE SCHEDULED TO UNDERGO HCT OR THOSE WHO HAVE UNDERGONE HCT: GVHD prophylaxis: investigator's choice based on center guidelines\n* PATIENTS WHO ARE SCHEDULED TO UNDERGO HCT OR THOSE WHO HAVE UNDERGONE HCT: Patients receiving menin inhibitors prior to alloHCT are eligible\n* PATIENTS WHO ARE SCHEDULED TO UNDERGO HCT OR THOSE WHO HAVE UNDERGONE HCT: Negative serum pregnancy test for female patients of childbearing potential who have already undergone alloHCT\n* PATIENTS WHO ARE SCHEDULED TO UNDERGO HCT OR THOSE WHO HAVE UNDERGONE HCT: If a female of childbearing potential, must be willing to use a highly effective method of contraception or double barrier method from the time of enrollment through 120 days following the last study drug dose\n* PATIENTS WHO ARE SCHEDULED TO UNDERGO HCT OR THOSE WHO HAVE UNDERGONE HCT: If male of childbearing potential, must agree to use barrier contraception from the time of enrollment through 120 days following the last study drug dose\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* PATIENTS WHO HAVE NOT YET UNDERGONE HCT: Participant has an Eastern Cooperative Oncology Group (ECOG) =\\\u003C 2 or Karnofsky Performance Status (KPS) \\>= 70, or a Lansky Performance Score of \\>= 70 (if aged \\\u003C 18 years)\n* PATIENTS WHO HAVE NOT YET UNDERGONE HCT: Participant must be eligible for alloHCT by City of Hope (COH) standard operating procedure (SOP) guidelines\n* CRITERIA TO PROCEED TO MAINTENANCE THERAPY WITH REVUMENIB: Patients should be in complete remission (CR) by day + 30 (± 7 days) post-HCT BM biopsy\n* CRITERIA TO PROCEED TO MAINTENANCE THERAPY WITH REVUMENIB: No evidence of active or uncontrolled infection at the time of start of revumenib therapy\n* CRITERIA TO PROCEED TO MAINTENANCE THERAPY WITH REVUMENIB: Participant has an ECOG =\\\u003C 2 or KPS \\>= 70, or Lansky Performance Score of \\>= 70 if aged \\\u003C 18 years\n* CRITERIA TO PROCEED TO MAINTENANCE THERAPY WITH REVUMENIB: No active grade 2-4 acute GVHD (prednisone dose of =\\\u003C 0.5 mg\u002Fkg daily is allowed)\n* CRITERIA TO PROCEED TO MAINTENANCE THERAPY WITH REVUMENIB: Hemoglobin (Hgb) \\>= 9. Transfusion or growth factors are not allowed to achieve these levels\n* CRITERIA TO PROCEED TO MAINTENANCE THERAPY WITH REVUMENIB: Platelets \\>= 75 thousand (k). Transfusion or growth factors are not allowed to achieve these levels\n* CRITERIA TO PROCEED TO MAINTENANCE THERAPY WITH REVUMENIB: Patients must be fully engrafted after HCT, defined as absolute neutrophil count (ANC) \\>= 500 for 3 days. Patients may NOT be given granulocyte colony-stimulating factor (GCSF) to meet eligibility criteria; however, they may receive GCSF after start of treatment\n* CRITERIA TO PROCEED TO MAINTENANCE THERAPY WITH REVUMENIB: No morphologic evidence of relapse post-HCT (pre-HCT MRD+ is)\n* CRITERIA TO PROCEED TO MAINTENANCE THERAPY WITH REVUMENIB: Participant is between day + 50 and + 150 after first alloHCT with no morphologic evidence of relapse post-HCT\n* CRITERIA TO PROCEED TO MAINTENANCE THERAPY WITH REVUMENIB: Total bilirubin =\\\u003C 1.5 x upper limit of normal (ULN) (unless considered to be due to Gilbert's syndrome)\n\n  * Note: Participants who are \\\u003C 75 years of age may have a bilirubin of =\\\u003C 3.0 x ULN. Patients with abnormal liver function tests (LFTs) in the context of active GVHD will not be included\n* CRITERIA TO PROCEED TO MAINTENANCE THERAPY WITH REVUMENIB: Aspartate aminotransferase (AST) =\\\u003C 2.5 x ULN\n* CRITERIA TO PROCEED TO MAINTENANCE THERAPY WITH REVUMENIB: Alanine aminotransferase (ALT) =\\\u003C 2.5 x ULN\n* CRITERIA TO PROCEED TO MAINTENANCE THERAPY WITH REVUMENIB: QTc using Fridericia's correction (QTcF) =\\\u003C 450 msec (males) or =\\\u003C 470 msec (females)\n* CRITERIA TO PROCEED TO MAINTENANCE THERAPY WITH REVUMENIB: Ejection fraction (EF) of \\>= 50% by echocardiogram or multigated acquisition (MUGA) scan\n* CRITERIA TO PROCEED TO MAINTENANCE THERAPY WITH REVUMENIB: Creatinine clearance of \\>= 60 mL\u002Fmin per 24 hour urine test or the Cockcroft-Gault formula\n\nExclusion Criteria:\n\n* PATIENTS WHO ARE SCHEDULED TO UNDERGO HCT OR THOSE WHO HAVE UNDERGONE HCT: Prior diagnosis of acute promyelocytic leukemia\n* PATIENTS WHO ARE SCHEDULED TO UNDERGO HCT OR THOSE WHO HAVE UNDERGONE HCT: Participants who are unable to take a strong CYP3A4 inhibitor such as voriconazole or posaconazole. Note: Patients must be taking a strong CYP3A4 inhibiting antifungal at least 7 days prior to starting revumenib cycle 1\n* PATIENTS WHO ARE SCHEDULED TO UNDERGO HCT OR THOSE WHO HAVE UNDERGONE HCT: Patients requiring the concurrent use of medications known or suspected to prolong the QT\u002Fcorrected QT (QTc) interval, with the exception of drugs with low risk of QT\u002FQTc prolongation that are used as standard supportive therapies (e.g., diphenhydramine, famotidine, ondansetron, bactrim, tacrolimus, azoles)\n* PATIENTS WHO ARE SCHEDULED TO UNDERGO HCT OR THOSE WHO HAVE UNDERGONE HCT: History of or any concurrent condition, therapy, laboratory abnormality, or allergy to excipients that in the investigator's opinion might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate\n* PATIENTS WHO ARE SCHEDULED TO UNDERGO HCT OR THOSE WHO HAVE UNDERGONE HCT: 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)\n* PATIENTS WHO HAVE NOT YET UNDERGONE HCT: Participant has detectable human immunodeficiency virus (HIV) viral load within the previous 6 months (must have viral load testing prior to study enrollment if participant has a known history of HIV 1\u002F2 antibodies)\n* PATIENTS WHO HAVE NOT YET UNDERGONE HCT: Active uncontrolled hepatitis B or C, defined as hepatitis B or C virus (HBV\u002FHCV) surface antigen positive and HBV\u002FHCV core antibody positive, with positive HBV\u002FHCV deoxyribonucleic acid (DNA), or HBV\u002FHCV positive core antibody alone with positive HBV\u002FHCV DNA\n* PATIENTS WHO HAVE NOT YET UNDERGONE HCT: Hepatitis C, defined as positive HCV antibody with reflex to positive HCV ribonucleic acid (RNA)\n* PATIENTS WHO HAVE NOT YET UNDERGONE HCT: Other active malignancy; patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* CRITERIA TO PROCEED TO MAINTENANCE THERAPY WITH REVUMENIB: Active grade II-IV acute GVHD, chronic GVHD (moderate or severe) and\u002For requiring systemic steroids with prednisone dose equivalent of \\>= 0.25mg\u002Fkg within 4 weeks of revumenib administration\n* CRITERIA TO PROCEED TO MAINTENANCE THERAPY WITH REVUMENIB: Participant has active uncontrolled systemic fungal, bacterial, or viral infection (defined as ongoing signs\u002Fsymptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and\u002For other treatment)\n* CRITERIA TO PROCEED TO MAINTENANCE THERAPY WITH REVUMENIB: Participants who are unable to take a strong CYP3A4 inhibitor such as voriconazole or posaconazole. Note: Patients must be taking a strong CYP3A4 inhibiting antifungal at least 7 days prior to starting revumenib in cycle 1\n* CRITERIA TO PROCEED TO MAINTENANCE THERAPY WITH REVUMENIB: Patients requiring the concurrent use of medications known or suspected to prolong the QT\u002FQTc interval, with the exception of drugs with low risk of QT\u002FQTc prolongation that are used as standard supportive therapies (e.g., diphenhydramine, famotidine, ondansetron, bactrim, tacrolimus, and azoles)\n* CRITERIA TO PROCEED TO MAINTENANCE THERAPY WITH REVUMENIB: Female participant who is pregnant or lactating\n* CRITERIA TO PROCEED TO MAINTENANCE THERAPY WITH REVUMENIB: Participant has a malabsorption syndrome or other condition that precludes enteral route of administration\n* CRITERIA TO PROCEED TO MAINTENANCE THERAPY WITH REVUMENIB: Participant has chronic respiratory disease that requires continuous oxygen, or significant renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, hepatic, cardiovascular disease, or any other medical condition that in the opinion of the investigator would adversely affect participation in this study\n* CRITERIA TO PROCEED TO MAINTENANCE THERAPY WITH REVUMENIB: Cardiac disease: any of the following within the 6 months prior to study entry:\n\n  * Myocardial infarction\n  * Uncontrolled\u002Funstable angina\n  * Congestive heart failure (New York Heart Association Classification class \\>= II)\n  * Life-threatening or uncontrolled arrhythmia\n  * Cerebrovascular accident\n  * Transient ischemic attack\n* CRITERIA TO PROCEED TO MAINTENANCE THERAPY WITH REVUMENIB: Gastrointestinal disease:\n\n  * Any gastrointestinal issue of the upper gastrointestinal (GI) tract likely to affect oral drug absorption or ingestion (e.g., gastric bypass, gastroparesis, etc.)\n  * Cirrhosis with a Child-Pugh score of B or C\n* CRITERIA TO PROCEED TO MAINTENANCE THERAPY WITH REVUMENIB: GVHD: Signs or symptoms of acute or cGVHD \\> grade 0 within 4 weeks of enrollment. Patients may be on physiological doses of steroids","2 Years",{"count":255,"type":20},27,[154],"This phase I trial tests the safety, side effects, best dose and effectiveness of revumenib in treating patients with acute leukemia after allogeneic stem cell transplant. Revumenib is in a class of medications called menin inhibitors. Revumenib targets and binds to the protein menin, thereby preventing the interaction between menin and the mixed lineage leukemia protein. Disrupting this interaction prevents the activation of specific genes that fuel the development of leukemia cells and inhibits the survival, growth, and production of certain kinds of leukemia cells. Giving revumenib may be safe, tolerable, and\u002For effective in treating patients with acute leukemia after allogeneic stem cell transplant.",[120,26,121,55,259,260,261,262],"Childhood Acute Leukemia","Childhood Acute Leukemia of Ambiguous Lineage","Childhood Acute Lymphoblastic Leukemia","Childhood Acute Myeloid Leukemia","2026-03-03",{"date":265,"type":32},"2026-03-05",{"date":267,"type":32},"2024-12-06",{"date":269,"type":20},"2028-04-29",{"name":271,"class":66},"City of Hope Medical Center",{"id":273,"slug":274,"hasResults":11,"nctId":275,"briefTitle":276,"officialTitle":277,"acronym":4,"eligibilityCriteria":278,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":279,"targetDuration":4,"studyType":21,"phases":281,"briefSummary":282,"conditions":283,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":286,"lastUpdatePostDateStruct":287,"startDateStruct":289,"completionDateStruct":291,"leadSponsor":293,"locationsCount":67},"100596485","phase-2-combination-chemotherapy-flag-ida-followed-immediately-by-reduced-intensity-total-body-radiation-therapy-and-donor-hematopoietic-cell-transplant-for-the-treatment-of-adults-age-60-and-older-with-newly-diagnosed-adverse-risk-acute-myeloid-leukemia-or-other-high-grade-myeloid-cancer-100596485","NCT07046078","Combination Chemotherapy (FLAG-Ida) Followed Immediately by Reduced-Intensity Total Body Radiation Therapy and Donor Hematopoietic Cell Transplant for the Treatment of Adults Age 60 and Older With Newly Diagnosed Adverse-Risk Acute Myeloid Leukemia or Other High-Grade Myeloid Cancer","Pilot Study of FLAG-Ida Followed Immediately by Reduced-Intensity Allogeneic HCT for Adults Age 60 and Older With Newly Diagnosed Adverse-Risk AML or Other High-Grade Myeloid Neoplasm","Inclusion Criteria:\n\n* PARTICIPANTS: Age ≥ 60 years. Adults age \\\u003C 60 years are eligible if they are felt to be unsuitable candidates for myeloablative conditioning as per physician assessment\n* PARTICIPANTS: Ability to understand and willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of potential study participants\n* PARTICIPANTS: Newly diagnosed, untreated high-risk myeloid or mixed myeloid\u002Flymphoid neoplasm:\n\n  * Adverse-risk AML (using 2022 International Consensus Classification for disease categorization and 2022 European LeukemiaNet \\[ELN\\] criteria for molecular\u002Fcytogenetic risk assignment)\n  * Acute leukemia of ambiguous lineage (using 2022 International Consensus Classification for disease categorization)\n  * High-risk myelodysplastic neoplasm (MDS) (Molecular International Prognostic System \\[IPSS-M\\] moderate high, high, or very high, OR ≥ 10% blasts in blood or marrow)\n  * High-risk chronic myelomonocytic leukemia (CMML) (clinical\u002Fmolecular CMML-specific prognostic scoring system \\[CPSS-Mol\\] intermediate-2 or high, OR ≥ 10% blasts in blood or marrow)\n\n    * Prior treatment of MDS or CMML with lower-intensity therapy (e.g., growth factors, erythropoiesis-stimulating agents, and lenalidomide) is permissible, but patients may not have received prior hypomethylating agents\n* PARTICIPANTS: Disease not requiring immediate anti-neoplastic therapy (e.g., presenting with leukopenia or pancytopenia), defined as a clinical scenario in which delay of systemic leukemia-directed treatment would be unsafe. Supportive cytoreduction with hydroxyurea for transient disease control is allowed, and does not constitute immediate anti-neoplastic treatment\n* PARTICIPANTS: Interest in pursuing allogeneic HCT\n* PARTICIPANTS: Available caregiver\n* PARTICIPANTS: Karnofsky score ≥ 70; Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* PARTICIPANTS: Bilirubin ≤ 2.5 x institutional upper limit of normal unless elevation is thought to be due to hepatic infiltration by myeloid neoplasm, Gilbert's syndrome, or hemolysis\n* PARTICIPANTS: Serum creatinine ≤ 1.5 mg\u002FdL\n* PARTICIPANTS: Prior autologous HCT is permissible if \\> 6 months after planned HCT on this study\n* PARTICIPANTS: Participants of child-bearing potential must be willing to employ two highly effective and acceptable forms of contraception 7 days before initiation of study treatment and for at least 12 months after HCT. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test during screening (within 2 weeks of treatment initiation, per Fred Hutch Cancer Center \\[FHCC\\] standard of care \\[SOC\\]), where WOCBP are defined as all female participants between 18-55 years of age, unless postmenopausal or with hysterectomy\n* PARTICIPANTS: HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* PARTICIPANTS: For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. Patients with HCV infection who are currently on treatment are eligible if they have an undetectable HCV viral load\n* PARTICIPANTS: 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, as determined by the investigator, are eligible for this trial\n* DONORS: Patients must have an HLA-matched related donor, an HLA-matched or mismatched unrelated donor, or an HLA- haploidentical donor who meets standard Fred Hutchinson Cancer Center (FHCC) and\u002For National Marrow Donor Program (NMDP) or other donor center criteria for peripheral blood stem cell (PBSC) donation as follows:\n\n  * HLA-matched related donor: related to the patient and genotypically or phenotypically identical for HLA-A, B, C, DRB1 and DQB1. Phenotypic identity must be confirmed by high-resolution typing\n  * HLA-matched unrelated donor:\n\n    * 10\u002F10 matched for HLA-A, B, C, DRB1 and DQB1 by high resolution typing\n    * Donors are excluded when preexisting immunoreactivity is identified that would jeopardize donor hematopoietic cell engraftment. The recommended procedure for patients with 10 of 10 HLA allele level (phenotypic) match is to obtain panel reactive antibody (PRA) screens to class I and class II antigens for all patients before HCT. If the PRA shows \\> 10% activity, then flow cytometric or B and T cell cytotoxic cross matches should be obtained. The donor should be excluded if any of the cytotoxic cross match assays are positive. A positive anti-donor cytotoxic crossmatch is an absolute donor exclusion\n  * HLA-mismatched unrelated donor:\n\n    * HLA-matching must be based on results of high resolution typing at HLA-A, -B, -C, -DRB1, and -DQ\n    * Mismatched for a single allele without antigen mismatching at HLA-A, B, or C as defined by high resolution typing but otherwise matched for HLA-A, B, C, DRB1 and DQB1 by high resolution typing\n    * HLA class I HLA-A, -B, -C allele matched donors allowing for any one or two DRB1 and\u002For DQB1 antigen\u002Fallele mismatch\n    * Donor\u002Frecipient HLA mismatching at loci for which the patient is homozygous is not allowed (isolated rejection vector)\n  * HLA-haploidentical donor:\n\n    * 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\n      * Donor age ≥ 12 years\n      * Donor weight ≥ 40 kg\n      * Ability of donors younger than 18 years of age to undergo apheresis without use of a vascular access device. Vein check must be performed and verified by an apheresis nurse prior to arrival\n      * 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    * In case of more than one available haploidentical donor, preference should be given to younger age\n    * 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. Use of donors requiring desensitization treatment of the patient are not permissible\n\nExclusion Criteria:\n\n* PARTICIPANTS: Active central nervous system (CNS) disease\n* PARTICIPANTS: Decompensated congestive heart failure and\u002For uncontrolled arrhythmia and\u002For significant medical history of cardiac disease precluding allogeneic HCT\n* PARTICIPANTS: Significant medical history of pulmonary disease and\u002For symptoms suggestive of pulmonary disease precluding allogeneic HCT\n* PARTICIPANTS: Treatment with any other approved or investigational anti-leukemia agent(s) at the time of initiation of study treatment\n* PARTICIPANTS: Concomitant illness associated with a likely survival of \\\u003C 1 year\n* PARTICIPANTS: 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 secondary to myeloid malignancy are eligible\n* PARTICIPANTS: Known hypersensitivity or contraindication to receiving any of the study drugs used in this trial, including post-transplant cyclophosphamide (PTCy)\n* PARTICIPANTS: Pregnancy or lactation\n* PARTICIPANTS: Psychiatric illness\u002Fsocial situations that would limit compliance with study requirements",{"count":280,"type":20},20,[23],"This phase II trial tests the safety, side effects, and how well combination chemotherapy with fludarabine, high-dose cytarabine, granulocyte colony-stimulating factor (G-CSF), and idarubicin (FLAG-Ida) followed immediately by reduced-intensity total body radiation therapy, called total body irradiation (TBI), and donor hematopoietic cell transplant (HCT) works in treating adults age 60 and older with newly diagnosed adverse-risk acute myeloid leukemia (AML) or other high-grade myeloid cancer. Despite advances in supportive care and the approval of more than 10 new drugs since 2017, the outcomes of older adults with adverse-risk acute myeloid leukemia and other high-grade myeloid cancers remains poor. Most patients are expected to die from their cancer or the consequences of treatment-related side effects. Donor HCT is a very important part of any curative-cancer treatment for these patients. However, while accepted as standard care for decades, this treatment exposes patients to long periods of drug-induced low blood cell counts and the problems associated with low blood counts, like infections and bleeding, which are associated with significant risk of chronic side effects and death. This study will use a different approach to the upfront curative-cancer treatment of older adults with an adverse-risk AML or other high-grade myeloid cancer. This study will use intense chemotherapy followed a few days later by lower-dose TBI and donor HCT. Chemotherapy drugs, such as idarubicin, fludarabine, high-dose 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. G-CSF helps the bone marrow make more white blood cells in patients with low white blood cell count due to cancer treatment. This approach allows effective treatment of cancer cells and overall reduction of the period of low blood cells counts. This decreases the risk for problems associated with low blood counts, such as infection and chronic side effects. Decreasing these are important for older adults who undergo HCT. This treatment strategy may improve treatment outcomes by allowing more patients to successfully undergo donor HCT and reduce the risk of low blood cell counts and the problems associated with low blood counts. Giving chemotherapy followed immediately by reduced-intensity TBI and donor HCT may be safe, tolerable and\u002For effective in treating adults age 60 and older with newly diagnosed adverse-risk AML or other high-grade myeloid cancer.",[26,55,284,285],"Chronic Myelomonocytic Leukemia","Myelodysplastic Syndrome","2026-01-28",{"date":288,"type":32},"2026-01-30",{"date":290,"type":32},"2025-09-26",{"date":292,"type":20},"2029-06-30",{"name":65,"class":66},{"id":295,"slug":296,"hasResults":11,"nctId":297,"briefTitle":298,"officialTitle":299,"acronym":4,"eligibilityCriteria":300,"healthyVolunteers":11,"sex":16,"minAge":112,"maxAge":301,"enrollmentInfo":302,"targetDuration":4,"studyType":21,"phases":304,"briefSummary":305,"conditions":306,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":310,"lastUpdatePostDateStruct":311,"startDateStruct":313,"completionDateStruct":315,"leadSponsor":317,"locationsCount":67},"100517121","phase-2-cord-blood-transplant-cyclophosphamide-fludarabine-and-total-body-irradiation-in-treating-patients-with-high-risk-hematologic-diseases-100517121","NCT06013423","Cord Blood Transplant, Cyclophosphamide, Fludarabine, and Total-Body Irradiation in Treating Patients With High-Risk Hematologic Diseases","Optimized Cord Blood Transplantation for the Treatment of High-Risk Hematologic Malignancies in Adults and Pediatrics","Inclusion Criteria:\n\n* Patients aged 6 months to =\\\u003C 65 years at time of consent.\n* Acute myelogenous leukemia (AML):\n\n  * Complete first remission (CR1), complete second remission (CR2) or greater (CR2+), must have \\\u003C 5% marrow blasts at the time of transplant.\n  * Patients in morphologic remission with persistent cytogenetic, flow cytometric, or molecular aberrations are eligible.\n* Acute lymphoblastic leukemia (ALL):\n\n  * Complete first remission (CR1) at high risk for relapse such as any of the following:\n\n    * Presence of any high-risk cytogenetic abnormalities such as t(9;22), t(1;19), t(4;11) or other MLL rearrangements (11q23) or other high-risk molecular abnormality.\n    * Failure to achieve MRD- complete remission after induction therapy.\n    * Persistence or recurrence of minimal residual disease on therapy.\n    * Any patient unable to tolerate consolidation and\u002For maintenance chemotherapy as would have been deemed appropriate by the treating physician.\n    * Other high-risk features not defined above.\n  * Complete second remission (CR2) or greater (CR2+).\n\n    * Note: ALL with less than 5% blasts at time of transplant but persistent cytogenetic, flow cytometric or molecular aberrations are eligible.\n* Other acute leukemias: Acute leukemias of ambiguous lineage or mixed phenotype with less than 5% blasts. Leukemias in morphologic remission with persistent cytogenetic, flow cytometric or molecular aberrations are eligible.\n* Chronic Myeloid Leukemia (CML): Excluding refractory blast crisis. To be eligible in first chronic phase (CP1) patient must have failed or be intolerant to tyrosine kinase inhibitor therapy.\n* Myelodysplastic syndromes (MDS) and myeloproliferative disorders (MPD) other than myelofibrosis:\n\n  * MDS\u002FMPD overlap syndromes without myelofibrosis.\n  * MDS\u002F MPD patients must have less than 10% bone marrow myeloblasts and absolute neutrophil count (ANC) \\> 0.2 (growth factor supported if necessary) at transplant work-up.\n* Non-Hodgkin lymphoma (NHL) at high-risk of relapse or progression if not in remission:\n\n  * Eligible patients with aggressive histology (such as, but not limited to, diffuse large B-cell NHL, mantle cell NHL, and T-cell histology) in CR by PET\u002FCT imaging.\n  * Eligible patients with indolent B-cell NHL (such as, but not limited to, follicular, small cell or marginal zone NHL) will have 2nd or subsequent progression with PR or CR by PET\u002FCT imaging.\n* Blastic plasmacytoid dendritic cell neoplasm (BPDCN) in morphologic remission.\n* Only for adult patients, to prevent graft rejection, patients who received only non-lymphodepleting agents for their malignancy (hypomethylating agents, venetoclax, hydroxyurea, TKIs etc.), or patients who received lymphodepleting chemotherapy \\> 3 months prior to scheduled admission, may receive fludarabine 25 mg\u002Fm\\^2 daily x 3 days for lymphodepletion 14-42 days (aiming for 2-4 weeks) at the discretion of the principal investigator (PI).\n* For patients \\> 18 years old, Karnofsky score ≥ 70%. For patients =\\\u003C 18 years old, Lansky score ≥ 50%.\n* Calculated creatinine clearance \\> 70 ml\u002Fmin.\n* Bilirubin \\\u003C 1.5 mg\u002FdL (unless benign congenital hyperbilirubinemia or hemolysis).\n* Alanine transaminase (ALT) \\\u003C 3 x upper limit of normal (ULN).\n* For patients \\> 18 years old, pulmonary function (spirometry and corrected diffusing capacity for carbon monoxide \\[DLCO\\]) \\> 60% predicted. For patients =\\\u003C 18 years old, or any patient unable to perform pulmonary function tests, O2 saturation \\> 92% on room air.\n* Left ventricular ejection fraction \\> 50%.\n* Albumin \\> 3.0 g\u002FdL.\n* For patients \\> 18 years old, Hematopoietic Cell Transplantation Comorbidity index (HCT-CI) =\\\u003C 5.\n* UCB units will be selected according to current umbilical cord blood graft selection algorithm. One or two UCB units may be used to achieve the required cell dose.\n* The UCB graft is matched at 4-6 HLA-A, B, DRB1 antigens with the recipient. This may include 0-2 antigen mismatches at the A or B or DRB1 loci. Unit selection based on cryopreserved nucleated cell dose and HLA-A, B, DRB1 using intermediate resolution A, B antigen and DRB1 allele typing.\n\nExclusion Criteria:\n\n* Diagnosis of myelofibrosis or other malignancy with moderate-severe bone marrow fibrosis.\n* Patients persistent with central nervous system (CNS) involvement in cerebrospinal fluid (CSF) or CNS imaging at time of screening0\n* Prior checkpoint inhibitors\u002F blockade in the last 12 months.\n* Two prior stem cell transplants of any kind.\n* One prior autologous stem cell transplant within the preceding 12 months.\n* Prior allogeneic transplantation.\n* Prior involved field radiation therapy that would preclude safe delivery of 400cGy total body irradiation (TBI) in the opinion of radiation oncology.\n* Active and uncontrolled infection at time of transplantation.\n* HIV infection.\n* Inadequate performance status\u002F organ function.\n* Pregnancy or breast feeding.\n* Patient or guardian unable to give informed consent or unable to comply with the treatment protocol including appropriate supportive care, long-term follow-up, and research tests.","65 Years",{"count":303,"type":20},54,[23],"This phase II trial studies how well giving an umbilical cord blood transplant together with cyclophosphamide, fludarabine, and total-body irradiation (TBI) works in treating patients with hematologic diseases. Giving chemotherapy, such as cyclophosphamide, fludarabine and thiotepa, and TBI before a donor cord blood transplant (CBT) helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil after transplant may stop this from happening in patients with high-risk hematologic diseases.",[26,121,55,124,307,127,285,134,308,309],"Hematopoietic and Lymphatic System Neoplasm","Non-Hodgkin Lymphoma","Chronic Myeloid Leukemia, BCR-ABL1 Positive","2026-01-20",{"date":312,"type":32},"2026-01-22",{"date":314,"type":32},"2024-07-23",{"date":316,"type":20},"2032-10-31",{"name":65,"class":66},{"id":319,"slug":320,"hasResults":11,"nctId":321,"briefTitle":322,"officialTitle":323,"acronym":4,"eligibilityCriteria":324,"healthyVolunteers":11,"sex":16,"minAge":325,"maxAge":4,"enrollmentInfo":326,"targetDuration":4,"studyType":21,"phases":328,"briefSummary":329,"conditions":330,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":331,"lastUpdatePostDateStruct":332,"startDateStruct":334,"completionDateStruct":336,"leadSponsor":338,"locationsCount":67},"100508557","phase-2-venetoclax-combined-with-azactidine-in-the-treatment-of-alal-100508557","NCT05901974","Venetoclax Combined With Azactidine in the Treatment of ALAL","A Multicenter Prospective Clinical Study of Venetoclax Combined With Azactidine in the Treatment of Acute Leukaemias of Ambiguous Lineage","Inclusion Criteria:\n\n1. Patients aged ≥ 15 years.\n2. Patients diagnosed with ALAL according to 5th edition of WHO Acute Leukaemias of Ambiguous Lineage diagnosis standard.\n3. New diagnosed patients.\n4. ECOG performance status score less than 3.\n5. Expected survival time ≥3 months.\n6. Patients without serious heart, lung, liver, or kidney disease.\n7. Ability to understand and voluntarily provide informed consent.\n\nExclusion Criteria:\n\n1. Patients who are allergic to the study drug or drugs with similar chemical structures.\n2. Pregnant or lactating women, and women of childbearing age who do not want to practice effective methods of contraception.\n3. Active infection.\n4. Active bleeding.\n5. Patients with new thrombosis, embolism, cerebral hemorrhage, or other diseases or a medical history within one year before enrollment.\n6. Patients with mental disorders or other conditions whereby informed consent cannot be obtained and where the requirements of the study treatment and procedures cannot be met.\n7. Liver function abnormalities (total bilirubin \\> 1.5 times the upper limit of the normal range, ALT\u002FAST \\> 2.5 times the upper limit of the normal range or patients with liver involvement whose ALT\u002FAST \\> 1.5 times the upper limit of the normal range), or renal anomalies (serum creatinine \\> 1.5 times the upper limit of the normal value).\n8. Patients with a history of clinically significant QTc interval prolongation (male \\> 450 ms; female \\> 470 ms), ventricular heart tachycardia and atrial fibrillation, II-degree heart block, myocardial infarction attack within one year before enrollment, and congestive heart failure, and patients with coronary heart disease who have clinical symptoms and requiring drug treatment.\n9. Surgery on the main organs within the past six weeks.\n10. Drug abuse or long-term alcohol abuse that would affect the evaluation results.\n11. Patients who have received organ transplants (excepting bone marrow transplantation).\n12. Patients not suitable for the study according to the investigator's assessment.","15 Years",{"count":327,"type":20},23,[23],"The prognosis of acute leukaemias of ambiguous lineage is poor. The effect of chemotherapy regimen and hematopoietic stem cell transplantation are still unclear. Therefore, we will explore new therapy to improve the remission rate of acute leukaemias of ambiguous lineage. Venetoclax can significantly improve the remission rate and prolong PFS and OS. At present, venetoclax combined with azacitidine or decitabine has become the preferred treatment regimen for elderly AML patients. It also shows a high response rate in relapsed\u002Frefractory AML or MDS patients. There are few clinical studies on the treatment of ALAL. The purpose of this study is to explore the efficacy and safety of venetoclax combined with azacitidine in the treatment of newly diagnosed ALAL patients.",[26],"2025-12-15",{"date":333,"type":32},"2025-12-16",{"date":335,"type":32},"2023-07-01",{"date":337,"type":20},"2026-03-01",{"name":339,"class":66},"Sheng-Li Xue, MD",{"id":341,"slug":342,"hasResults":11,"nctId":343,"briefTitle":344,"officialTitle":345,"acronym":4,"eligibilityCriteria":346,"healthyVolunteers":11,"sex":16,"minAge":347,"maxAge":4,"enrollmentInfo":348,"targetDuration":4,"studyType":21,"phases":349,"briefSummary":350,"conditions":351,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":352,"lastUpdatePostDateStruct":353,"startDateStruct":355,"completionDateStruct":357,"leadSponsor":359,"locationsCount":67},"100396297","phase-2-efficacy-of-acute-lymphoblastic-leukemia-based-therapy-in-treating-patients-with-acute-leukemia-of-ambiguous-lineage-100396297","NCT04440267","Efficacy of Acute Lymphoblastic Leukemia-Based Therapy in Treating Patients With Acute Leukemia of Ambiguous Lineage","A Prospective, Single Arm, Open Label, Clinical Trial to Evaluate the Efficacy of Acute Lymphoblastic Leukemia-Based Therapy in Treating Patients With Acute Leukemia of Ambiguous Lineage","Inclusion Criteria:\n\n1. Patients aged above 14 years with acute leukemia of ambiguous lineage .\n2. Eastern Cooperative Oncology Group (ECOG) Performance status 2.\n3. Adequate end organ function as defined by: Total bilirubin ≤ 1.5 x upper limit of normal (ULN); serum glutamic-oxaloacetic transaminase(SGOT) and serum glutamic pyruvic transaminase(SGPT) ≤ 2.5 x ULN; Creatinine ≤ 1.5 x ULN; Serum amylase and lipase ≤ 1.5 x ULN; Alkaline phosphatase ≤ 2.5 x ULN unless considered tumor related; Patients must have adequate cardiac function (ejection fraction ≥ 45 % on Multiple Gated Acquisition (MUGA) scan).\n4. Patients must have the following laboratory values (≥ lower limit of normal (LLN) or corrected to within normal limits with supplements prior to the first dose of study medication.): Potassium ≥ LLN; Magnesium ≥ LLN; Phosphorus ≥ LLN\n5. Patients should sign informed consent form.\n\nExclusion Criteria:\n\n1. Impaired cardiac function:\n\n   Long QT syndrome or a known family history of long QT syndrome; clinically significant resting brachycardia (\\\u003C50 beats per minute); ejection fraction \\\u003C 45 % on MUGA scan. Corrected QT (QTc) interval \\> 450 msec on baseline ECG (using the QTcF formula). If QTcF interval\\>450 msec and electrolytes are not within normal ranges, electrolytes should be corrected and then the patient re-screened for QTc. Myocardial infarction within 12 months prior to starting study; other clinically significant heart disease (e.g. unstable angina, congestive heart failure or uncontrolled hypertension, uncontrolled arrhythmias).\n2. Other concurrent severe and\u002For uncontrolled medical conditions:\n\n   Patients with another primary malignant disease, except those that do not currently require treatment; acute or chronic liver, pancreatic or severe renal disease; another severe and\u002For life-threatening medical disease.\n3. Patients who are: (a) pregnant and (b) breast feeding.","14 Years",{"count":50,"type":20},[23],"In this prospective, single arm, open label, clinical trial, a total of 50 acute leukemia of ambiguous lineage patients will be enrolled. Patients will receive acute lymphoblastic leukemia (ALL) -based chemotherapy and are permitted to receive allogeneic hematopoietic stem cell transplantation (HSCT) after CR . Otherwise, they will finish the consolidation chemotherapy. Patients with t(9;22) will receive chemotherapy combined with tyrosine kinase inhibitors. The purpose of current study is to evaluate the clinical efficacy of ALL-based chemotherapy，effect of genetic abnormality and minimal residual disease (MRD) on prognosis in patients with acute leukemia of ambiguous lineage.",[26],"2025-08-01",{"date":354,"type":32},"2025-08-06",{"date":356,"type":32},"2020-07-08",{"date":358,"type":20},"2027-12-20",{"name":360,"class":66},"Institute of Hematology & Blood Diseases Hospital, China",{"id":362,"slug":363,"hasResults":11,"nctId":364,"briefTitle":365,"officialTitle":365,"acronym":366,"eligibilityCriteria":367,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":368,"targetDuration":4,"studyType":21,"phases":369,"briefSummary":370,"conditions":371,"keywords":374,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":375,"lastUpdatePostDateStruct":376,"startDateStruct":378,"completionDateStruct":380,"leadSponsor":382,"locationsCount":384},"100543416","phase-2-intestinal-microbiota-transplant-prior-to-allogeneic-stem-cell-transplant-mast-trial-100543416","NCT06355583","Intestinal Microbiota Transplant Prior to Allogeneic Stem Cell Transplant (MAST) Trial","MAST","Inclusion Criteria:\n\n1. \\- Patients aged 18 years and over with a morphological documented diagnosis of ALL, acute myeloid leukemia (AML), AL of ambiguous lineage, myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia (CMML), and CML in blast phase (Appendix 2) who are deemed fit for allogenic HCT with one of the following disease characteristics: ALL, AML, AL of ambiguous lineage\n\n   * Patients in first complete remission (CR1) or second complete remission (CR2) including complete remission with incomplete blood count recovery with \\\u003C 5% blasts (Appendix 2)\n   * Secondary leukaemia (defined as previous history of MDS, antecedent haematological disease or chemotherapy exposure) in CR1 or CR2 defined as \\\u003C 5% blasts (Appendix 2) MDS and CMML\n   * Patients with advanced or high risk MDS with an International Prognostic Scoring System (IPSS-M) moderate high or higher including intermediate or high risk CMML who have \\\u003C 5% blasts at the time of randomisation (Appendix 2) CML in blast phase\n   * Patients with Philadelphia or BCR:ABL1 positive chronic myeloid leukaemia (CML) in blast phase defined by the presence of ≥ 20% blasts in blood or bone marrow who have achieved second chronic phase with \\\u003C 5% blasts (Appendix 2).\n2. Patients must have completed minimum of two cycles of intensive chemotherapy prior to trial enrolment (Appendix 1)\n3. Patients must have received broad-spectrum antibiotics within 3 months prior to trial enrolment\n4. Patients must be considered suitable\u002Ffit to undergo allogeneic hematopoietic cell transplantation (HCT) as clinically judged by the Local investigator\n5. Patients with an Karnofsky performance status score 60 or above (Appendix 3)\n6. Females of and male patients of reproductive potential (i.e., not post-menopausal or surgically sterilised) must use appropriate, highly effective, contraception from the point of commencing therapy until 6 months after treatment\n7. Patients have given written informed consent\n8. Patients willing and able to comply with scheduled study visits and laboratory tests\n\nExclusion Criteria:\n\n1. Patients with contraindications to receiving allogeneic HCT.\n2. Female patients who are pregnant or breastfeeding. All women of childbearing potential must have a negative pregnancy test before commencing treatment.\n3. Adults of reproductive potential not willing to use appropriate, highly effective, contraception during the specified period.\n4. Patients with renal or hepatic impairment as clinically judged by the Local Investigator.\n5. Patients with active infection, HIV-positive or chronic active hepatitis B virus (HBV) or hepatitis C virus (HCV).\n6. Patients with a concurrent active malignancy or a prior malignancy, except lobular breast carcinoma in situ, fully resected basal cell or squamous cell carcinoma of skin or treated cervical carcinoma in situ, incidental histologic finding of prostate cancer (T1a or T1b using the tumour, node, metastasis (TNM) clinical staging system), previous MDS, CMML, Myeloproliferative neoplasms (MPN) resulting in secondary AML. Cancer treated with curative intent ≥ 5 years previously will be allowed. Cancer treated with curative intent \\\u003C 5 years previously will not be allowed.\n7. Swallowing difficulties that may preclude safe use of IMT capsules.\n8. Administration of IMT within 3 months prior to enrolment (probiotic administration prior to enrolment is allowed but should be recorded at screening).\n9. Patients taking probiotics after enrolment to the trial.\n10. Gastrointestinal disorders and diseases, including delayed gastric emptying, coeliac disease, cystic fibrosis, inflammatory bowel disease, irritable bowel syndrome, chronic diarrhoea, and colonic perforation or fistula.\n11. Any autoimmune disease requiring, or that may require, systemic treatment with steroids and\u002For other immunosuppressants\u002Fimmunomodulators.\n12. Significant bleeding disorder (ALL, AML, AL of ambiguous lineage, MDS, CMML, and CML satisfying inclusion criteria are not excluded).\n13. Anaphylactic food allergy.\n14. Requirement for vasopressors.\n15. Valvular heart disease or known structural defects of the heart.\n16. Known severe allergy to capsule components.",{"count":50,"type":20},[23],"The goal of this clinical trial is to test the ability to restore gut microbiota to healthier levels in patients with blood cancers scheduled to have stem cell transplant.\n\nThe main questions it aims to answer are:\n\n* Tolerability and acceptability of intestinal microbiota transplantation (IMT) versus placebo (as assessed via patient perspective questionnaires\n* Changes in gut microbiome diversity across all timepoints\n* Markers of general health, infective\u002Fmicrobiological and haematological outcomes including, days of fever, admission to intensive care unit, survival, non-relapsed mortality, and incidence of graft-versus-host disease across all time points measured.\n\nParticipants will be asked at their routine follow up visits to,\n\n* Provide stool, urine and blood samples at the scheduled study visits\n* Complete questionnaires at selected visits\n* Swallow either Placebo or IMT capsules once at the second study visit which will occur 2 weeks prior to the stem cell transplant (+\u002F-3 days)\n\nResearchers will compare IMT capsules and Placebo to investigate the change in gut microbiota diversity.",[372,26,373,284,285,55],"Acute Lymphoblastic Leukaemia","Chronic Myeloid Leukemia",[366],"2025-04-14",{"date":377,"type":32},"2025-04-17",{"date":379,"type":32},"2024-05-01",{"date":381,"type":20},"2027-05-01",{"name":383,"class":66},"Imperial College London",8]