[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acute-leukemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acute-leukemia":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,57,0,25,[9,49,106,136,210,243,267,299,320,354,382,409,435,456,478,506,532,579,601,624,650,671,696,720,743],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100636402","phase-1-thiotepa-based-conditioning-regimen-with-de-escalated-post-graft-cyclophosphamide-for-allogeneic-stem-cell-transplantation-in-hematologic-malignancies-100636402",false,"NCT07565220","Thiotepa-based Conditioning Regimen With De-escalated Post-graft Cyclophosphamide for Allogeneic Stem Cell Transplantation in Hematologic Malignancies","Phase 1 Trial of Thiotepa-based Conditioning Regimen With De-escalated Post-graft Cyclophosphamide for Allogeneic Stem Cell Transplantation in Hematologic Malignancies","Inclusion Criteria:\n\n1. Patients must be considered appropriate candidates for either the low- or high-intensity conditioning regimen for allogeneic hematopoietic stem cell transplantation based on the following age-related criteria:\n\n   1. Age 50-70 years old or\n   2. Age 18-49 and unfit for a conventional myeloablative conditioning regimen per the treating physician\n2. Patients have one of the following diagnoses:\n\n   1. Acute lymphocytic leukemia (ALL) in first or subsequent morphological remission (\\\u003C5% marrow blasts by morphology).\n   2. Acute myeloid leukemia (AML) in first or subsequent morphological remission (\\\u003C5% marrow blasts by morphology) with or without hematologic recovery.\n   3. Other acute leukemia or related neoplasm (including but not limited to 'mixed phenotype' 'biphenotypic', 'acute undifferentiated' or 'ambiguous lineage' acute leukemia, blastic plasmacytoid dendritic cell neoplasm, lymphoblastic lymphoma, Burkitt leukemia\u002Flymphoma, mast cell leukemia or chronic myeloid leukemia with blast crisis) in first or subsequent morphological remission (\\\u003C5% marrow blasts by morphology) with or without hematologic recovery.\n   4. Myelodysplastic syndrome (MDS) with a history of excess blasts, with \\>5% marrow blasts by morphology after receiving at least one cycle of treatment, including but not limited to hypomethylating agent, BCL-2 inhibitor, cytoreductive chemotherapy.\n   5. High-risk myeloproliferative neoplasm (MPN) with no evidence of high-grade bone marrow fibrosis or massive splenomegaly at the time of enrollment.\n3. Patients with an 8\u002F8 HLA-matched (HLA-A, B, C, DRB1) related or unrelated donor capable of donating peripheral blood stem cells (PBSC)\n4. Provision of signed and dated informed consent form\n5. Sexually active fertile subjects and their partners must agree to use highly effective methods of contraception prior to study entry, during the course of the study, and until tacrolimus or other immunosuppressive therapy for GVHD is discontinued (whichever is later). An additional contraceptive method, such as a barrier method (e.g., condom), is required. In addition, men must agree not to donate sperm and women must agree not to donate eggs (ova, oocyte) for the purpose of reproduction during these same periods.\n6. Female subjects of childbearing potential must not be pregnant or breastfeeding at screening. Female subjects are considered to be of childbearing potential unless one of the following criteria is met:\n\n   1. Permanent sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or documented postmenopausal status (defined as 12 months of amenorrhea in a woman \\> 45 years-of-age in the absence of other biological or physiological causes). Note: Documentation may include review of medical records, medical examination, or medical history interview by study site staff.\n\nExclusion Criteria:\n\nSubjects will be excluded from the study if they meet any of the following criteria.\n\nFor high-intensity regimen:\n\n1. Poor performance status with Karnofsky Score \\\u003C70%\n2. Center for International Blood and Marrow Transplant Research (CIBMTR) hematopoietic cell transplant co-morbidity index (HCT-CI) score \\>5\n3. Patients with active central nervous system (CNS) involvement refractory to intrathecal chemotherapy and\u002For standard craniospinal radiation.\n4. Patients who are positive for HIV-1, HIV-2, HTLV1 or HTLV2.\n5. Patients with uncontrolled infections for whom alloSCT is considered contraindicated by the consulting infectious disease physician.\n6. Patients with organ dysfunction, including:\n\n   1. Renal insufficiency creatinine clearance \\\u003C45 ml\u002Fmin\u002F1.72m2 measured by 24-hr urine specimen\n   2. Left ventricular ejection fraction \\\u003C45%\n   3. Diffusing capacity of the lung for carbon monoxide (DLCO) corrected \\\u003C50% or FEV1 \\\u003C50%\n   4. Liver function abnormality: total bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) \\>5 times the upper limit of normal should be evaluated by a gastroenterologist. If a gastroenterologist considers that alloSCT is contraindicated, the patient will be excluded from the protocol.\n7. Patients who have received previous allogeneic transplantation.\n8. Patients with a life expectancy \\\u003C12 months due to co-existing diseases other than hematologic malignancies.\n9. Patients with any other significant medical conditions that would make them unsuitable for transplantation, as determined by the PI.\n10. Patients with a known hypersensitivity to cyclophosphamide, thiotepa, fludarabine, busulfan, tacrolimus, or mycophenolate mofetil (MMF).\n11. Patients who have received checkpoint inhibitors within three months of transplantation, unless an exception is made by the PI.\n\nFor low-intensity regimen\n\n1. Poor performance status with Karnofsky Score \\\u003C60%\n2. Patients with active CNS involvement refractory to intrathecal chemotherapy and\u002For standard craniospinal radiation.\n3. Patients who are positive for HIV-1, HIV-2, HTLV1 or HTLV2.\n4. Patients with uncontrolled infections for whom alloSCT is considered contraindicated by the consulting infectious disease physician.\n5. Patients with organ dysfunction, including:\n\n   1. Renal insufficiency creatinine clearance \\\u003C40 ml\u002Fmin\u002F1.72m2 measured by 24-hr urine specimen\n   2. Left ventricular ejection fraction \\\u003C40%\n   3. DLCO corrected\\\u003C 50% or FEV1\\\u003C50%\n   4. Liver function abnormality: total bilirubin, AST, ALT\\>5 times the upper limit of normal should be evaluated by a gastroenterologist. If a gastroenterologist considers that alloSCT is contraindicated, the patient will be excluded from the protocol.\n6. Patients who have received previous allogeneic transplantation.\n7. Patients with a life expectancy \\\u003C12 months from co-existing disease other than hematologic malignancies\n8. Patients with any other significant medical conditions that would make them unsuitable for transplantation, as determined by the PI.\n9. Patients with a known hypersensitivity to cyclophosphamide, thiotepa, fludarabine, busulfan, tacrolimus, or mycophenolate mofetil (MMF).\n10. Patients who have received checkpoint inhibitors within three months of transplantation, unless an exception is made by the PI.","ALL","18 Years",{"count":20,"type":21},48,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This phase 1 trial will investigate the safety and effectiveness of Thiotepa, Busulfan, and Fludarabine (TBF) conditioning regimen with post-transplant cyclophosphamide (PTCy) in HLA-matched related or unrelated donor allogeneic stem cell transplantation (alloSCT).",[27,28,29,30,31],"Acute Lymphocytic Leukemia (ALL)","Acute Myeloid Leukemia (AML)","Acute Leukemia","Myelodysplastic Syndrome(MDS)","Myeloproliferative Neoplasm (MPN)",[33,34,35],"allogeneic hematopoietic stem cell transplantation","HLA","graft-versus-host disease (GVHD)","RECRUITING","2026-06-29",{"date":39,"type":40},"2026-07-01","ACTUAL",{"date":42,"type":21},"2026-08-01",{"date":44,"type":21},"2030-11-01",{"name":46,"class":47},"Sawa Ito, MD","OTHER",1,{"id":50,"slug":51,"hasResults":12,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":61,"conditions":62,"keywords":90,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":48},"100309946","phase-2-myeloablative-allo-hsct-with-related-or-unrelated-donor-for-heme-disorders-100309946","NCT03314974","Myeloablative Allo HSCT With Related or Unrelated Donor for Heme Disorders","Myeloablative Allogeneic Hematopoietic Cell Transplantation Using a Related or Unrelated Donor for the Treatment of Hematological Diseases","-Inclusion Criteria:\n\n* Age: ≤ 60 years of age\n* Performance Status: Karnofsky ≥ 70%, Lansky play score ≥ 70\n* Consent: Voluntary written consent (adult or legally authorized representative; or parental\u002Fguardian)\n* Adequate Organ Function:\n\n  * Renal: Creatinine \\\u003C2x upper limit of normal. Patients above this limit must have creatinine clearance ≥ 40 ml\u002Fmin\u002F1.73m2 as determined by an age-appropriate method, such as cystatin C GFR.\n  * Hepatic: Bilirubin, AST, alkaline phosphatase \\\u003C4 times the upper limit of institutional normal\n  * Pulmonary: Diffusion capacity of oxygen, corrected for hemoglobin, \\> 50% of predicted. For pediatric patients not able to undergo PFTs or diffusion testing: O2 sat of \\>95% on room air\n  * Cardiac: Absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction \\> 45%. For children not able to cooperate with MUGA or echocardiography, such should be clearly stated in the physician's documentation\n  * HIV Status: HIV infection with undetectable viral load. All HIV+ patients must be evaluated by Infectious Disease (ID) and a HIV management plan establish prior to transplantation\n\nOther Inclusion Criteria:\n\n* Women of child bearing potential and sexually active males with partners of child bearing potential must agree to use adequate birth control for the duration of treatment.\n* Donor Availability: Patients considered for transplantation must have a sufficient graft as based on current criteria of the University of Minnesota Blood and Marrow Transplantation Program\n* Eligible Diseases and Status: Patients are eligible unless their treatment is to be guided by a higher priority protocol.\n* Acute Leukemias: Must be in remission by morphology (≤5% blasts). Also a small percentage of blasts that is equivocal between marrow regeneration vs. early relapse are acceptable provided there are no associated cytogenetic markers consistent with relapse.\n* Acute Myeloid Leukemia (AML) and related precursor neoplasms: 2nd or greater complete remission (CR); first complete remission (CR1) in patients \\> 60 years old; CR1 in ≤ 60 years old that is NOT considered as favorable-risk.\n* Favorable risk AML is defined as having one of the following:\n\n  * t(8,21) without cKIT mutation\n  * inv(16) or t(16;16) without cKIT mutation\n  * Normal karyotype with mutated NPM1 and wild type FLT-ITD\n  * Normal karyotype with double mutated CEBPA\n  * Acute prolymphocytic leukemia (APL) in first molecular remission at the end of consolidation\n* Very high risk pediatric patients with AML: Patients \\\u003C21 years, however, are eligible with (M2 marrow) with \\\u003C 25% blasts in marrow after having failed one or more cycles of chemotherapy.\n* Acute lymphoblastic leukemia (ALL)\u002Flymphoma: second or greater CR; CR1 unable to tolerate consolidation chemotherapy due to chemotherapy-related toxicities; CR1 high-risk ALL.\n* High risk ALL is defined as having one of the following:\n\n  * Evidence of high risk cytogenetics, e.g. t(9;22), t(1;19), t(4;11), other MLL rearrangements, IKZF1\n  * 30 years of age or older at diagnosis\n  * White blood cell counts of greater than 30,000\u002FmcL (B-ALL) or greater than 100,000\u002FmcL (T-ALL) at diagnosis\n  * CNS leukemia involvement during the course of disease\n  * Slow cytologic response (\\>10% lymphoblasts in bone marrow on Day 14 of induction therapy)\n  * Evidence of persistent immonophenotypic or molecular minimal residual disease (MRD) at the end of induction and consolidation therapy\n* Very high risk pediatric patients with ALL: patients \\\u003C21 years are also considered high risk CR1 if they had M2 or M3 marrow at day 42 from the initiation of induction or M3 marrow at the end of induction. They are eligible once they achieve a complete remission.\n* Chronic Myelogenous Leukemia excluding refractory blast crisis: To be eligible in first chronic phase (CP1) patient must have failed or be intolerant to one or more tyrosine kinase inhibitors.\n* Plasma Cell Leukemia after initial therapy, in patients who have achieved at least a partial remission\n* Myeloproliferative Neoplasms\u002FMyelofibrosis, either primary as a result of polycythemia vera or essential thrombocythemia, with disease risk of intermediate or high-risk according to DIPSS criteria. Blasts must be \\\u003C10% by bone marrow aspirate morphology.\n* Myelodysplasia (MDS) IPSS INT-2 or High Risk (i.e. RAEB, RAEBt) or Refractory Anemia with severe pancytopenia, transfusion dependence, or high risk cytogenetics or molecular features. Blasts must be \\\u003C 10% by a representative bone marrow aspirate morphology.\n* Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma (CLL\u002FSLL), Marginal Zone B-Cell Lymphoma or Follicular Lymphoma are eligible if there was disease progression\u002Frelapse within 12 of achieving a partial or complete remission. Patients who had remissions lasting \\> 12 months, are eligible after at least two prior therapies. Patients with bulky disease (nodal mass greater than 5 cm) should be considered for debulking chemotherapy before transplant.\n* Lymphoplasmacytic Lymphoma, Mantle-Cell Lymphoma, Prolymphocytic Leukemia are eligible after initial therapy in CR1+ or PR1+.\n* Diffuse large Cell NHL \\> CR\u002F\\> PR: Patients in CR\u002FPR with initial short remission (\\\u003C6 months) are eligible, or those who have failed\u002For are not eligible for autologous transplant.\n* Lymphoblastic Lymphoma, Burkitt's Lymphoma, and other high-grade NHL after initial therapy if stage III\u002FIV in CR1\u002FPR1 or after progression if stage I\u002FII \\\u003C 1 year.\n* Multiple Myeloma beyond PR2: Patients with chromosome 13 abnormalities, first response lasting less than 6 months, or β-2 microglobulin \\> 3 mg\u002FL, may be considered for this protocol after initial therapy.\n* Juvenile myelomonocytic leukemia\n* Biphenotypic\u002FUndifferentiated\u002FProlymphocytic Leukemias in first or subsequent CR.\n* MRD positive leukemia (AML, ALL or accelerated\u002Fblast phase CML). Selected patients in morphologic CR, but with positive immunophenotypic (flow cytometry) or molecular evidence of MRD may be eligible if recent chemotherapy has not resulted in MRD negative status.\n* Natural Killer Cell Malignancies\n* Acquired Bone Marrow Failure Syndromes except for Fanconi Anemia or Dyskeratosis Congenita\n* Other Leukemia Subtypes: A major effort in the field of hematology is to identify patients who are of high risk for treatment failure so that patients can be appropriately stratified to either more (or less) intensive therapy. This effort is continually ongoing and retrospective studies identify new disease features or characteristics that are associated with treatment outcomes. Therefore, if new features are identified after the writing of this protocol, patients can be enrolled with the approval of two members of the study committee.\n\nExclusion Criteria:\n\n* Chemotherapy refractory large cell and high grade NHL (i.e., progressive disease after \\> 2 salvage regimens)\n* CML in blast crisis\n* Large cell lymphoma, mantle cell lymphoma and Hodgkin disease that is progressing on salvage therapy.\n* Evidence of progressive disease by imaging modalities or biopsy - persistent PET activity, though possibly related to lymphoma, is not an exclusion criterion in the absence of CT changes indicating progression.\n* Active central nervous system malignancy\n* if ≤ 18 years old, prior myeloablative transplant within the last 6 months. If \\>18 years old prior myeloablative allotransplant or autologous transplant\n* Active HIV infection or known HIV positive serology\n* active uncontrolled infection\n* Pregnant or breastfeeding. The agents used in this study include Pregnancy Category D: known to cause harm to a fetus. Females of childbearing potential must have a negative pregnancy test prior to starting therapy.","60 Years",{"count":58,"type":21},300,[60],"PHASE2","This is a Phase II study of allogeneic hematopoietic stem cell transplant (HCT) using a myeloablative preparative regimen (of either total body irradiation (TBI); or, fludarabine\u002Fbusulfan for patients unable to receive further radiation). followed by a post-transplant graft-versus-host disease (GVHD) prophylaxis regimen of post-transplant cyclophosphamide (PTCy), tacrolimus (Tac), and mycophenolate mofetil (MMF).",[29,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89],"Acute Myeloid Leukemia","Acute Lymphoblastic Leukemia","Lymphoma","Chronic Myelogenous Leukemia","Plasma Cell Leukemia","Myeloproliferative Neoplasms","Myelofibrosis","Myelodysplasia","Refractory Anemia","High Risk Anemia","Chronic Lymphocytic Leukemia","Small Lymphocytic Lymphoma","Marginal Zone B-Cell Lymphoma","Follicular Lymphoma","Lymphoplasmacytic Lymphoma","Mantle-Cell Lymphoma","Prolymphocytic Leukemia","Diffuse Large Cell Non Hodgkins Lymphoma","Lymphoblastic Lymphoma","Burkitt Lymphoma","High Grade Non-Hodgkin's Lymphoma, Adult","Multiple Myeloma","Juvenile Myelomonocytic Leukemia","Biphenotypic\u002FUndifferentiated\u002FProlymphocytic Leukemias","MRD Positive Leukemia","Natural Killer Cell Malignancies","Acquired Bone Marrow Failure Syndromes",[91,17,92,93,94,95,96],"AML","MDS","NHL","CLL","CML","SLL","2026-06-23",{"date":99,"type":40},"2026-06-25",{"date":101,"type":40},"2018-03-30",{"date":103,"type":21},"2028-06-10",{"name":105,"class":47},"Masonic Cancer Center, University of Minnesota",{"id":107,"slug":108,"hasResults":12,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":12,"sex":17,"minAge":113,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":22,"phases":116,"briefSummary":117,"conditions":118,"keywords":124,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":135},"100620325","phase-1-a-study-of-revumenib-and-mezigdomide-in-people-with-leukemia-100620325","NCT07356154","A Study of Revumenib and Mezigdomide in People With Leukemia","A Phase 1\u002F2 Study of the Menin Inhibitor Revumenib With the CELMod Mezigdomide in Relapsed\u002FRefractory KMT2A-rearanged, NPM1-mutant, and NUP98-rearranged Acute Leukemias","Inclusion Criteria:\n\n* Participant must be ≥ 12 years of age at the time of signing the informed consent form (ICF).\n* Participant must weigh at least 40 kg\n* Participant is willing and able to adhere to the study visit schedule and other protocol requirements.\n* Participant has relapsed\u002Frefractory acute leukemia defined acute myeloid leukemia, acute lymphoblastic leukemia, or mixed phenotype acute leukemia after as failure of at least 1 prior line of therapy (can be either primary refractory disease or progression during or after treatment)\n* Participant has confirmed acute leukemia with detectable NPM1c, KMT2A translocation, or NUP98 translocation.\n\n  1. At MSK, NPM1 testing utilizes MSK-REACT, a rapid multi-gene NGS panel used in all new AML diagnoses that is clinically validated by the Laboratory of Diagnostic Molecular Pathology pursuant to the requirements of CLIA'88 and approved by New York State, or MSK-IMPACT, a multi-gene NGS panel, which is authorized by the FDA. At non-MSK sites, NPM1 testing may be performed in local CLIA-certified laboratories using validated clinical assays with capable of detecting NPM1c variants at a frequency of ≥5%. Eligible patients must have an NPM1c (nucleophosmin) exon 12 variant as determined by these assays.\n  2. At MSK, KMT2A and NUP98 testing will utilize chromosomal analysis and fluorescence in situ hybridization studies. At non-MSK sites, testing may be performed in local CLIA-certified laboratories using validated clinical assays with performance characteristics sufficient to detect relevant translocations. Eligible patients must have a KMT2A or NUP98 translocation as determined by these assays\n  3. The patient's chart will be utilized for screening purposes\n* Regarding prior treatment with a menin inhibitor:\n\n  1. Participants enrolled in Phase 1 have no requirements regarding prior treatment with a menin inhibitor\n  2. Participants enrolled in Phase 2, cohort 1, are required to be menin inhibitor naïve (no previous treatment with a menin inhibitor)\n  3. Participants enrolled in Phase 2, cohort 2, are required to be menin inhibitor exposed (previous treatment received a menin inhibitor)\n* Regarding prior alloSCT, at 60 days must have elapsed from day of transplant and at least 4 weeks must have elapsed from first dose of donor lymphocyte infusion.\n* Participant has an Eastern Cooperative Oncology Group (ECOG) performance status score 0-2 (if aged ≥18 years); Karnofsky Performance Scale of ≥50 (if aged ≥16 years and \\\u003C18 years); Lansky Performance Score of ≥50 (if aged \\\u003C16 years).\n* Participant must have a WBC count \\\u003C25,000\u002FμL at the time of initiation of study drug (leukapheresis may be performed and\u002For hydroxyurea may be administered to decrease the WBC count to \\\u003C25,000\u002FμL).\n* Participant has adequate organ function defined as:\n\n  1. Serum aspartate aminotransferase\u002Fserum glutamic oxaloacetic transaminase (AST\u002FSGOT) and alanine aminotransferase (ALT\u002FSGPT) ≤ 3 x ULN, unless considered due to leukemic organ involvement.\n  2. Serum total bilirubin \\\u003C 1.5 x ULN. Higher levels are acceptable if these can be attributed to ineffective erythropoiesis, leukemia organ involvement or Gilbert's syndrome.\n  3. Serum creatinine \\\u003C 2 x ULN or estimated glomerular filtration rate 60 mL\u002Fmin or greater based on local institutional practice for age-appropriate determination (e.g, Schwartz formula for pediatric patients or Cockcroft Gault formula for adults).\n  4. Adequate cardiac function defined as ejection fraction of ≥ 50% by echocardiogram or multigated acquisition scan.\n\nExclusion Criteria:\n\n* Participants with acute promyelocytic leukemia\n* Participants with isolated myeloid sarcoma\n* Participants who have previously received mezigdomide.\n* Participants with immediate life-threatening, severe complications of leukemia such as uncontrolled bleeding, pneumonia with hypoxia or shock, disseminated intravascular coagulation, or uncontrolled tumor lysis syndrome.\n* Participant has presence of any other condition that may increase the risk associated with study participation, and in the opinion of the treating investigator, would make the patient inappropriate for entry into the study.\n* Participants with concurrent other malignancy that will confound interpretation of study endpoints.\n* Participants who have received other anti-leukemia therapy within 5 half-lives of the agent or 14 days, whichever is sooner, prior to study treatment and if toxicity related to said agent has not resolved; exceptions of acceptable concomitant therapies are listed below\n\n  1. Concomitant cytoreductive therapy in the form of hydroxyurea, corticosteroids, or cytarabine is permitted.\n  2. Concomitant therapy in the form of intrathecal chemotherapy for CNS treatment, is permitted.\n  3. Radiation therapy is not permitted except for localized palliative radiation to focal lesions after discussion with the Medical Monitor for patients who have progressed but remain on the study due to perceived clinical benefit per Investigator assessment\n* Participants with active graft versus host disease (GVHD) of grade 2 or higher requiring systemic treatment. Skin GVHD solely managed with topical corticosteroids would not be exclusionary.\n* Participant has significant active cardiac disease within 6 months prior to start of study treatment, including New York Heart Association (NYHA) class III or IV congestive heart failure; acute coronary syndrome (ACS); and\u002For stroke.\n* Participant has QTc interval (i.e., Fridericia's correction \\[QTcF\\]) ≥ 450 ms (mean of triplicate ECG) or other factors that increase the risk of QT prolongation or ventricular arrhythmic events (e.g., family history of long QT interval syndrome). Patients with a QTcF over 450 ms due to a bundle branch block or a pacemaker may participate in the study with approval of the study principal investigator.\n* Participant has active viral infection with human immunodeficiency virus (HIV), or active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)\n* Participant is known to have dysphagia, short-gut syndrome, gastroparesis, or other conditions that limit the ingestion or gastrointestinal absorption of drugs administered orally.\n* 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* Participant with active use of strong or moderate CYP3A4 inhibitors or strong CYP3A4 inducers. Details reviewed in Appendix B.\n* Participant with use of proton pump inhibitors less than 2 weeks prior to initiating treatment\n* Female participant who is pregnant or lactating. Male or female participants not willing to comply with contraceptive requirements, which include 4 months of contraception after last dose of revumenib for males and 6 months for females. Additional contraception details reviewed in Appendix D.","12 Years",{"count":115,"type":21},52,[24,60],"The purpose of this study is to find out whether the combination of mezigdomide and revumenib is a safe treatment for people with relapsed or refractory KMT2A-r, NUP98-r, and NPM1-m acute leukemias.",[119,29,120,121,122,63,64,123],"Leukemia","Relapse Leukemia","Refractory Leukemia","Refractory Acute Leukemia","Mixed Phenotype Acute Leukemia",[119,29,120,121,122,63,64,123,125,126],"Memorial Sloan Kettering Cancer Center","25-229","2026-06-18",{"date":129,"type":40},"2026-06-22",{"date":131,"type":40},"2026-01-16",{"date":133,"type":21},"2029-01-16",{"name":125,"class":47},10,{"id":137,"slug":138,"hasResults":12,"nctId":139,"briefTitle":140,"officialTitle":140,"acronym":141,"eligibilityCriteria":142,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":143,"targetDuration":4,"studyType":145,"phases":4,"briefSummary":146,"conditions":147,"keywords":191,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":202,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":48},"100289631","familial-investigations-of-childhood-cancer-predisposition-100289631","NCT03050268","Familial Investigations of Childhood Cancer Predisposition","SJFAMILY","NOTE: This is a research study and is not meant to be a substitute for clinical genetic testing. Families may never receive results from the study or may receive results many years from the time they enroll. If you are interested in clinical testing please consider seeing a local genetic counselor or other genetics professional. If you have already had clinical genetic testing and meet eligibility criteria for this study as shown below, you may enroll regardless of the results of your clinical genetic testing.\n\nDEFINITION OF FAMILIAR CANCER FOR THIS PROTOCOL:\n\nIn this protocol, the definition of \"Familial Cancer\" is met if any of the following is present:\n\n* An individual with a history of cancer diagnosed under 26 years of age who has at least one first, second or third degree relative with a history of cancer diagnosed under 51 years of age; OR\n* An individual who has been diagnosed with more than one cancer, at least one of which was diagnosed under 26 years of age; OR\n* An individual with a clinical or molecular diagnosis of a known cancer predisposition syndrome; OR\n* An individual with a congenital cancer diagnosed before 6 months of age; OR\n* An individual with a rare pediatric cancer or tumor diagnosed before 26 years of age\n\nº Excluding human papilloma virus-associated cervical cancer and non-melanoma skin cancer occurring in adults.\n\nINCLUSION CRITERIA:\n\n* An individual who meets this protocol's definition of \"Familial Cancer,\" as above.\n* Biologic relatives of an individual meeting this protocol's definition of \"Familial Cancer,\" who are either affected or unaffected by cancer.\n\nEXCLUSION CRITERIA:\n\n* An inability or unwillingness of the research participant or his\u002Fher legally authorized representative (LAR) to provide written informed consent.\n* The participant has received allogeneic bone marrow transplantation and has NO pre-transplant germline (cancer-unaffected) DNA available AND is unwilling to provide a skin sample.",{"count":144,"type":21},1500,"OBSERVATIONAL","NOTE: This is a research study and is not meant to be a substitute for clinical genetic testing. Families may never receive results from the study or may receive results many years from the time they enroll. If you are interested in clinical testing please consider seeing a local genetic counselor or other genetics professional. If you have already had clinical genetic testing and meet eligibility criteria for this study as shown in the Eligibility Section, you may enroll regardless of the results of your clinical genetic testing.\n\nWhile it is well recognized that hereditary factors contribute to the development of a subset of human cancers, the cause for many cancers remains unknown. The application of next generation sequencing (NGS) technologies has expanded knowledge in the field of hereditary cancer predisposition. Currently, more than 100 cancer predisposing genes have been identified, and it is now estimated that approximately 10% of all cancer patients have an underlying genetic predisposition.\n\nThe purpose of this protocol is to identify novel cancer predisposing genes and\u002For genetic variants. For this study, the investigators will establish a Data Registry linked to a Repository of biological samples. Health information, blood samples and occasionally leftover tumor samples will be collected from individuals with familial cancer. The investigators will use NGS approaches to find changes in genes that may be important in the development of familial cancer. The information gained from this study may provide new and better ways to diagnose and care for people with hereditary cancer.\n\nPRIMARY OBJECTIVE:\n\n* Establish a registry of families with clustering of cancer in which clinical data are linked to a repository of cryopreserved blood cells, germline DNA, and tumor tissues from the proband and other family members.\n\nSECONDARY OBJECTIVE:\n\n* Identify novel cancer predisposing genes and\u002For genetic variants in families with clustering of cancer for which the underlying genetic basis is unknown.",[29,148,149,91,150,151,152,153,154,155,156,157,158,159,160,161,162,163,164,165,166,167,168,169,170,92,171,172,173,174,175,176,177,178,179,180,181,182,183,184,185,186,187,188,189,190],"Adenomatous Polyposis","Adrenocortical Carcinoma","BAP1 Tumor Predisposition Syndrome","Carney Complex","Choroid Plexus Carcinoma","Constitutional Mismatch Repair Deficiency Syndrome","Diamond-Blackfan Anemia","DICER1 Syndrome","Dyskeratosis Congenita","Emberger Syndrome","Familial Acute Myeloid Leukemia","Familial Adenomatous Polyposis","Fanconi Anemia","Familial Cancer","Familial Wilms Tumor","Familial Neuroblastoma","GIST","Hereditary Breast and Ovarian Cancer","Hereditary Paraganglioma-Pheochromocytoma Syndrome","Hodgkin Lymphoma","Juvenile Polyposis","Li-Fraumeni Syndrome","Lynch Syndrome","Melanoma Syndrome","Multiple Endocrine Neoplasia Type 1","Multiple Endocrine Neoplasia Type 2","Neuroblastoma","Neurofibromatosis Type 1","Neurofibromatosis Type II","Nevoid Basal Cell Carcinoma Syndrome","Non Hodgkin Lymphoma","Noonan Syndrome and Other Rasopathy","Overgrowth Syndromes","Pancreatic Cancer","Peutz-Jeghers Syndrome","Pheochromocytoma\u002FParaganglioma","PTEN Hamartoma Tumor Syndrome","Retinoblastoma","Rhabdoid Tumor Predisposition Syndrome","Rhabdomyosarcoma","Rothmund-Thomson Syndrome","Tuberous Sclerosis","Von Hippel-Lindau Disease",[192,193,194,195,196,197,198,199,200],"Familial cancer","Genetic predisposition","Heritable disease","Cancer risk","Genome analysis","Genetic modifiers","Next generation sequencing (NGS)","Genetic counseling","DNA","2026-06-15",{"date":203,"type":40},"2026-06-17",{"date":205,"type":40},"2017-04-06",{"date":207,"type":21},"2037-03-31",{"name":209,"class":47},"St. Jude Children's Research Hospital",{"id":211,"slug":212,"hasResults":12,"nctId":213,"briefTitle":214,"officialTitle":214,"acronym":215,"eligibilityCriteria":216,"healthyVolunteers":217,"sex":17,"minAge":218,"maxAge":4,"enrollmentInfo":219,"targetDuration":4,"studyType":22,"phases":221,"briefSummary":223,"conditions":224,"keywords":226,"overallStatus":234,"whyStopped":4,"lastUpdateSubmitDate":235,"lastUpdatePostDateStruct":236,"startDateStruct":238,"completionDateStruct":239,"leadSponsor":241,"locationsCount":48},"100643735","strength-training-exercise-in-pediatric-acute-lymphoblastic-leukemia-and-lymphoblastic-lymphoma-step-all-100643735","NCT07634653","Strength Training Exercise in Pediatric Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma (STEP-ALL)","STEP-ALL","Inclusion Criteria for children:\n\nAll subjects must meet the following criteria:\n\n* Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information. OR Written assent and parental\u002Flegal guardian consent.\n* Age \\>= 6 and \\\u003C =21 years at the time of diagnosis.\n* Newly- diagnosed with one of the following diseases: B-cell or T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma\n\nExclusion Criteria for children:\n\n* Subjects must not be receiving any investigational or additional anti-cancer medicines during induction.\n* Significant concurrent disease, illness, or psychiatric disorder or social issue that would compromise subject safety or adherence to the protocol treatment or procedures, interfere with consent, study participation, follow-up, or interpretation of the study results.\n\nOptional caregiver participation:\n\nInclusion Criteria :All caregivers must meet the following criteria\n\n* Written informed consent to participate in the caregiver interviews.\n* The caregiver must be a parent or legal guardian ≥ 18 years old, and their child must be \\\u003C18 years",true,"6 Years",{"count":220,"type":21},40,[222],"NA","Acute lymphoblastic leukemia (ALL) is the most common cancer in children and, along with lymphoblastic lymphoma, represents the most common group of childhood lymphoid malignancies. Survival rates have improved over the years, but many children still experience long-term side effects from treatment. These can include tiredness, weak muscles, pain, nerve problems, difficulty moving, and other physical challenges. Many children with ALL are also overweight at diagnosis, and weight gain often continues during treatment. As a result, about half of childhood leukemia survivors have a BMI at or above the 85th percentile.\n\nTreatment decisions are usually based on a child's symptoms and genetic risk factors. However, some risk factors such as physical activity can be modified. Exercise during treatment may help children feel better and may even improve survival. However, research on early symptom tracking and structured exercise during the first phase of chemotherapy is limited, uses different methods, and often does not include reliable patient-reported symptoms.\n\nEffective exercise programs for children with ALL and lymphoblastic lymphoma need to consider the child's age, treatment side effects, motivation, family support, and ways to encourage long-term behavior change. Because children spend little time in the hospital during the induction phase, a mix of in-person and virtual sessions supported by real-time Zoom instruction can make it possible to offer safe and supervised exercise at home.\n\nThis study will use a guided exercise plan that includes tools to track sets, repetitions, intensity, warm-up time, and perceived exertion. These tools help with consistent monitoring and support both patients and caregivers throughout the program. Twenty children newly diagnosed with ALL or lymphoblastic lymphoma who receive standard 3-4 drug induction chemotherapy will be invited to participate. Our goal is to determine whether a 9-week hybrid exercise program, combined with weekly symptom check-ins, is practical and achievable in both hospital and home settings.",[119,29,225,81,64],"Acute Lymphoid Leukemia",[227,228,229,230,231,232,233],"children","pediatric","weight gain","body mass index (BMI)","physical activity","Exercise","hybrid exercise program","NOT_YET_RECRUITING","2026-06-08",{"date":237,"type":40},"2026-06-10",{"date":235,"type":21},{"date":240,"type":21},"2028-06-01",{"name":242,"class":47},"UNC Lineberger Comprehensive Cancer Center",{"id":244,"slug":245,"hasResults":12,"nctId":246,"briefTitle":247,"officialTitle":248,"acronym":249,"eligibilityCriteria":250,"healthyVolunteers":12,"sex":17,"minAge":251,"maxAge":4,"enrollmentInfo":252,"targetDuration":4,"studyType":22,"phases":254,"briefSummary":255,"conditions":256,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":257,"lastUpdatePostDateStruct":258,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":263,"locationsCount":266},"100424796","phase-1-a-phase-12-study-of-bleximenib-in-participants-with-acute-leukemia-camelot-1-100424796","NCT04811560","A Phase 1\u002F2 Study of Bleximenib in Participants With Acute Leukemia (cAMeLot-1)","A Phase 1\u002F2, First-in-Human Study of the Menin-KMT2A (MLL1) Inhibitor Bleximenib in Participants With Acute Leukemia (cAMeLot-1)","cAMeLot-1","Inclusion Criteria:\n\nPhase 1:\n\n* Age 2 years to less than (\\\u003C) 18 years of age (pediatric cohort only), all other cohorts 18 years and above\n* Relapsed or refractory (R\u002FR) acute leukemia and has exhausted, or is ineligible for, available therapeutic options\n* Acute leukemia harboring histone-lysine N-methyltransferase 2A (KMT2A), nucleophosmin 1 gene (NPM1) or nucleoporin 98 gene or nucleoporin 214 gene (NUP98 or NUP214) alterations\n\nPhase: 2\n\n* Participants greater than 18 years are eligible\n* Must have had an initial diagnosis of acute myeloid leukemia (AML) per the WHO 2022 classification criteria and have relapsed\u002Frefractory disease\n* AML harboring KMT2A-r (gene rearrangement\u002Ftranslocation) or NPM1 mutations only\n\nFor Both Phase 1 and 2:\n\n* Pretreatment clinical laboratory values meeting the following criteria: (a) Hematology: white blood cell (WBC) count \\\u003C= 20\\*10\\^9\u002Fliter (L) and (b) renal function; For adult participants, estimated or measured glomerular filtration rate \\>= 30 milliliter per minute (mL\u002Fmin) per four variable MDRD equation. For pediatric participants an estimated or measured glomerular filtration rate \\>=40 mL\u002Fmin per the CKiD (Chronic Kidney Disease in Children) Schwartz formula\n* Eastern Cooperative Oncology Group (ECOG) performance status grade of 0, 1 or 2. Pediatric participants only: Performance status \\>=70 by Lansky scale (for participants \\\u003C 16 years of age) or \\>=70 Karnofsky scale (for participants \\>=16 years of age)\n* A female of childbearing potential must have a negative highly sensitive serum beta-human chorionic gonadotropin at screening and within 48 hours prior to the first dose of study treatment\n* Participant must agree to all protocol required contraception requirements and avoid sperm or egg donations or freezing for future reproductive use while on study and for 90 days (males) or 6 months (females) after the last dose of study treatment\n\nExclusion Criteria:\n\n* Acute promyelocytic leukemia, diagnosis of Down syndrome associated leukemia or juvenile myelomonocytic leukemia according to World Health Organization (WHO) 2016 criteria\n* Active central nervous system (CNS) disease\n* Prior solid organ transplantation\n* QTc according to Fridericia's formula (QTcF) for males \\>= 450 millisecond (msec) or for females \\>= 470 msec. Participants with a family history of Long QT syndrome are excluded\n* Exclusion criteria related to stem cell transplant: a. Received prior treatment with allogenic bone marrow or stem cell transplant \\\u003C=3 months before the first dose of study treatment ; b. Has evidence of graft versus host disease; c. Received donor lymphocyte infusion \\\u003C=1 month before the first dose of study treatment; d. Requires immunosuppressant therapy (exception: daily doses \\\u003C=10 milligrams (mg) prednisone or equivalent are allowed for adrenal replacement)\n* Prior cancer immunotherapy within 4 weeks prior to enrollment or blinatumomab within 2 weeks prior to enrollment. Additional prior cancer therapies must not be given within 4 weeks prior to enrollment or 5 half-lives of the agent (whichever is shorter)","2 Years",{"count":253,"type":21},420,[24,60],"The purpose of this study is to determine the recommended Phase 2 dose(s) (RP2D\\[s\\]) of bleximenib in phase 1 Part 1 (Dose Escalation) and to determine the safety and tolerability at RP2D in Phase 1 Part 2 (Dose expansion). The purpose of the Phase 2 part of the study is to evaluate the efficacy of bleximenib at the RP2D.",[29],"2026-06-04",{"date":235,"type":40},{"date":260,"type":40},"2021-05-19",{"date":262,"type":21},"2030-09-22",{"name":264,"class":265},"Janssen Research & Development, LLC","INDUSTRY",102,{"id":268,"slug":269,"hasResults":12,"nctId":270,"briefTitle":271,"officialTitle":272,"acronym":4,"eligibilityCriteria":273,"healthyVolunteers":217,"sex":17,"minAge":274,"maxAge":4,"enrollmentInfo":275,"targetDuration":4,"studyType":22,"phases":277,"briefSummary":278,"conditions":279,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":290,"lastUpdatePostDateStruct":291,"startDateStruct":293,"completionDateStruct":295,"leadSponsor":297,"locationsCount":48},"100377523","phase-2-donor-stem-cell-transplant-with-treosulfan-fludarabine-and-total-body-irradiation-for-the-treatment-of-hematological-malignancies-100377523","NCT04195633","Donor Stem Cell Transplant With Treosulfan, Fludarabine, and Total-Body Irradiation for the Treatment of Hematological Malignancies","Hematopoietic Stem Cell Transplantation From Haploidentical Donors in Patients With Hematological Malignancies Using a Treosulfan-Based Preparative Regimen","Inclusion Criteria:\n\n* Acute leukemia (AL) that includes acute myeloid leukemia (AML) \u002F acute lymphoblastic leukemia (ALL) \u002F mixed phenotype leukemia (MPAL) in complete morphological remission (CR) with or without detectable minimal residual disease (MRD); complete morphological remission is defined by the presence of less than 5% of detectable blasts in bone marrow specimen, evaluated per standard of care. Patients with documented CR but without hematologic recovery since last chemotherapy are considered eligible to the study\n* Chronic myelogenous leukemia (CML), except refractory blast crisis. To be eligible in first chronic phase, patients must have failed or be intolerant to at least one tyrosine-kinase inhibitor\n* Chronic myelomonocytic leukemia (CMML)\n* Myelodysplastic syndromes (MDS)\n* Lymphoblastic, Burkitt's and other high-grade lymphoma in any complete (CR) or partial (PR) response\n\n  * CR and PR are defined according to Lugano classification: Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification\n* Low grade lymphoma (chronic lymphocytic leukemia \\[CLL\\]\u002Fsmall lymphocytic lymphoma \\[SLL\\], marginal zone lymphoma, follicular lymphoma) progressed after two treatment regimens, in CR\u002FPR\n\n  * For CLL\u002FSLL, CR and PR are defined according to: International Workshop on CLL (iwCLL) guidelines for diagnosis, indications for treatment, response assessment, and supportive management of CLL\n  * CR and PR are defined according to Lugano classification: Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification\n* Large cell lymphoma in \\> second CR (CR2)\u002F \\>= PR2\n\n  * CR and PR are defined according to Lugano classification: Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification\n* Mantle cell lymphoma, lymphoplasmacytic lymphoma and prolymphocytic leukemia may be eligible after initial therapy if in CR\u002FPR\n\n  * CR and PR are defined according to Lugano classification: Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification\n  * For prolymphocytic leukemia (PLL), CR is defined as a normalization of lymphadenopathies (long-axis diameter \\\u003C 1 cm) and splenomegaly (\\\u003C 13 cm), absence of constitutional symptoms, PLL cells \\\u003C 5% in bone marrow and circulating lymphocytes count \\\u003C 4 x 10\\^9\u002FL. Patients without hematopoietic recovery are considered eligible to the study. PR is defined as a decrease of \\>= 30% of the sum of lymphadenopathies' long-axis diameters, a decrease of \\>= 50% in spleen vertical length beyond normal from baseline, peripheral blood (PB) lymphocytes =\\\u003C 30 x 10\\^9\u002FL (and a decrease of \\>= 50% from baseline)\n* Hodgkin Lymphoma in \\> CR2\u002FPR2\n\n  * CR and PR are defined according to Lugano classification: Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification\n* Subjects must be \\>= 6 months old\n* Karnofsky \\>= 70 or Eastern Cooperative Oncology Group (ECOG) 0-1 (for adults)\n* Lansky score \\>= 50 (for children)\n* Adequate cardiac function defined as absence of decompensated congestive heart failure or uncontrolled arrhythmia AND left ventricular ejection fraction \\>= 40% or shortening fraction \\> 22%\n* Adequate pulmonary function defined as absence of oxygen (O2) requirements and one of the following:\n\n  * Diffusion capacity of the lung for carbon monoxide (DLCO) corrected \\>= 70% mm Hg\n  * DLCO corrected between 60% - 69% mm Hg and partial pressure of oxygen (pO2) \\>= 70 mm Hg\n  * DLCO corrected between 50% - 59% mm Hg and pO2 \\>= 80 mm Hg Pediatric patients unable to perform pulmonary function tests must have O2 saturation \\>= 92% on room air. May not be on supplemental oxygen\n* Total bilirubin \\\u003C 2 x upper limit of normal (ULN) unless felt to be related to Gilbert's disease or hemolysis\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\\\u003C 2.5 x ULN\n* Alkaline phosphatase =\\\u003C 5 x ULN\n* Creatinine \\\u003C 2.0 mg\u002Fdl (adults) or estimated creatinine clearance \\> 40 ml\u002Fmin (pediatrics)\n\n  * All adults with a creatinine \\> 1.2 or a history of renal dysfunction must have estimated creatinine clearance \\> 40 ml\u002Fmin\n* If recent mold infection, e.g., aspergillus, must be cleared by infectious disease to proceed\n* Patients who have undergone prior allogeneic hematopoietic cell transplant are eligible, but the prior transplant must have been performed at least 3 months prior to enrollment, unless in case of graft failure from the prior transplant\n* Written and signed informed consent\n* DONOR: Donors must be haploidentical relatives of the patients. Donor-recipient compatibility will be tested through HLA typing at high resolution for the HLA loci (-A, -B, -C, -DRB1, -DQB1). Donor and recipient should share at least 5\u002F10 HLA loci\n* DONOR: Age \\>= 12 years\n* DONOR: Weight \\>= 40 Kg\n* DONOR: 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: Donor must meet selection criteria as defined by the Foundation of the Accreditation of Cell Therapy (FACT) and will be screened per the American Association of Blood Banks (AABB) guidelines\n* DONOR: In case of more available haploidentical donors, selection criteria should include, in this order:\n\n  * For cytomegalovirus (CMV) seronegative recipients, a CMV seronegative donor\n  * Red blood cell compatibility\n\n    * Red blood cell (RBC) cross match compatible\n    * Minor ABO incompatibility\n    * Major ABO incompatibility\n\nExclusion Criteria:\n\n* Active, uncontrolled, life-threatening viral, bacterial or fungal infection requiring treatment at time of conditioning regiment administration and transplantation\n* Presence of a malignancy other than the one for which the transplant is being performed, with an expected survival less than 75% at 5 years\n* Pregnant or breastfeeding\n* Known hypersensitivity to treosulfan, fludarabine or cyclophosphamide\n* Dosing with another investigational agent within 30 days prior to entry in the study\n* Central nervous system (CNS) leukemic involvement not clearing with intrathecal chemotherapy and\u002For cranial radiation prior to initiation of conditioning (day -6)\n* DONOR: Since detection of anti-donor-specific-antigen antibodies (anti-DSA) is associated with higher graft rejection rate, patients will be screened for anti-DSA pre-transplant. Patients with DSA mean fluorescent intensity (MFI) \\\u003C 5000 after desensitization treatment, will be considered eligible to participate in the study. The first 10 subjects enrolled in the trial will be DSA-negative.","6 Months",{"count":276,"type":21},60,[60],"This phase II trial studies how well a donor stem cell transplant, treosulfan, fludarabine, and total-body irradiation work in treating patients with blood cancers (hematological malignancies). Giving chemotherapy and total-body irradiation before a donor stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. It may also 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. The donated stem cells may also replace the patient's immune cells and help destroy any remaining cancer cells.",[29,64,63,280,281,82,282,283,167,81,77,284,123,285,79,286,287,288,289],"Adult Diffuse Large Cell Lymphoma","Anaplastic Large Cell Lymphoma","Chronic Myeloid Leukemia, BCR-ABL1 Positive","Chronic Myelomonocytic Leukemia","Mantle Cell Lymphoma","Myelodysplastic Syndrome","Refractory Chronic Lymphocytic Leukemia","Refractory Follicular Lymphoma","Refractory Marginal Zone Lymphoma","Refractory Small Lymphocytic Lymphoma","2026-05-27",{"date":292,"type":40},"2026-05-29",{"date":294,"type":40},"2021-01-25",{"date":296,"type":21},"2029-03-12",{"name":298,"class":47},"Fred Hutchinson Cancer Center",{"id":300,"slug":301,"hasResults":12,"nctId":302,"briefTitle":303,"officialTitle":303,"acronym":4,"eligibilityCriteria":304,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":305,"targetDuration":4,"studyType":22,"phases":307,"briefSummary":308,"conditions":309,"keywords":310,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":311,"lastUpdatePostDateStruct":312,"startDateStruct":314,"completionDateStruct":316,"leadSponsor":318,"locationsCount":48},"100585855","tools-for-reducing-inequity-in-acute-leukemia-trial-beta-testing-100585855","NCT06907797","Tools for Reducing Inequity in Acute Leukemia (TRIAL): Beta Testing","Inclusion Criteria:\n\n* Age 18 or older\n* English speaking\n* Ability to understand and willingness to sign written informed consent\n* Clinical suspicion of acute leukemia\n* Admitted to DFCI-affiliated inpatient unit\n\nExclusion Criteria:\n\n* Cognitive impairment rendering the individual unable to participate in beta testing\n\n  * This will be assessed by focused chart review and consultation with the patients' inpatient care team.\n* The following populations will be excluded: adults unable to consent, individuals who are not yet adults (infants, children, teenagers \\\u003C18 years old), prisoners.\n* Inability to participate in in-person application testing.\n* Patients who participated in alpha-testing through protocol 23-404 (Appendix A)",{"count":306,"type":21},75,[222],"This study aims to test the Tools for Reducing Inequity in Acute Leukemia (TRIAL) web-based application that is designed to support participants with acute leukemia by providing information and resources about leukemia and clinical trial participation.",[29,119],[29,119],"2026-05-18",{"date":313,"type":40},"2026-05-20",{"date":315,"type":40},"2025-04-01",{"date":317,"type":21},"2027-06-30",{"name":319,"class":47},"Dana-Farber Cancer Institute",{"id":321,"slug":322,"hasResults":12,"nctId":323,"briefTitle":324,"officialTitle":325,"acronym":4,"eligibilityCriteria":326,"healthyVolunteers":217,"sex":17,"minAge":274,"maxAge":327,"enrollmentInfo":328,"targetDuration":4,"studyType":22,"phases":330,"briefSummary":331,"conditions":332,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":346,"lastUpdatePostDateStruct":347,"startDateStruct":349,"completionDateStruct":351,"leadSponsor":353,"locationsCount":135},"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).","26 Years",{"count":329,"type":21},68,[60],"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.",[333,29,334,64,335,336,337,338,339,123,340,341,342,343,81,344,345],"Acute Biphenotypic Leukemia","Acute Leukemia of Ambiguous Lineage","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","Myelodysplastic Syndrome With Excess Blasts-1","Myelodysplastic Syndrome\u002FAcute Myeloid Leukemia","Burkitt Leukemia","Chronic Monocytic Leukemia","Mast Cell Leukemia","Myeloproliferative Neoplasm","2026-05-11",{"date":348,"type":40},"2026-05-14",{"date":350,"type":40},"2019-08-29",{"date":352,"type":21},"2028-12-31",{"name":298,"class":47},{"id":355,"slug":356,"hasResults":12,"nctId":357,"briefTitle":358,"officialTitle":359,"acronym":4,"eligibilityCriteria":360,"healthyVolunteers":12,"sex":17,"minAge":361,"maxAge":362,"enrollmentInfo":363,"targetDuration":4,"studyType":22,"phases":365,"briefSummary":366,"conditions":367,"keywords":368,"overallStatus":234,"whyStopped":4,"lastUpdateSubmitDate":373,"lastUpdatePostDateStruct":374,"startDateStruct":376,"completionDateStruct":378,"leadSponsor":380,"locationsCount":48},"100637009","phase-1-study-of-quail-100-in-pediatric-and-young-adult-participants-with-high-risk-hematologic-malignancies-who-have-received-a-hematopoietic-stem-cell-transplantation-100637009","NCT07573111","Study of QUAIL-100 in Pediatric and Young Adult Participants With High-Risk Hematologic Malignancies Who Have Received a Hematopoietic Stem Cell Transplantation","An Open-label, First-in-Human, Single Ascending Dose Study of QUAIL-100 in Pediatric and Young Adult Subjects With High-Risk Acute Leukemias and Myelodysplastic Syndrome Who Have Received a T-cell Receptor (TCR) αβ+ T Cell\u002FCD-19+ B Cell-Depleted Hematopoietic Stem Cell Transplantation","Inclusion Criteria:\n\n* Weight \\>\u002F= 10 kg\n* Have received HLA-partially matched related or unrelated donor ab-depleted hematopoietic stem cell transplant (HSCT) for high-risk malignant disease and has achieved myeloid and platelet engraftment\n* Lanksy\u002FKarnofsky score \\> 60\n* Participants of childbearing potential must agree to use contraception to prevent pregnancy\n\nExclusion Criteria:\n\n* Active Grade II acute graft versus host disease (aGVHD) requiring \\> 0.5 mg\u002Fkg methylprednisolone or any diagnosis of Grade III\u002FIV aGVHD\n* Significant cardiac, pulmonary, renal, hepatic, GI, neurological or immunological disease that could compromise safe participation\n* Known allergies, hypersensitivity or intolerance to both amoxicillin and gentamycin\n* Implanted medical devices with high potential for bacterial seeding, including pacemakers, artificial cardiac valves, prosthetic joints, orthopedic plates or screws, atrial appendage or inferior vena cava devices for thrombosis prevention\n* Planned anti-leukemic therapy within 21 days of planned dosing\n* Use of tumor necrosis factor (TNF) a or phosphatidylinositol 3-kinase (PI3K) inhibitors within 60 days of screening\n* Any prior investigational Listeria product including QUAIL-100\n* Live, attenuated vaccine within 4 weeks of first dose","18 Months","39 Years",{"count":364,"type":21},12,[24],"Study of QUAIL-100 in Patients With High Risk Acute Leukemia and Myelodysplastic Syndrome Who Have Received Hematopoietic Stem Cell Transplant",[29,285],[119,369,27,28,370,371,372],"Myelodysplastic Syndrome (MDS)","transplant","hematopoietic stem cell transplant","LGNA-100","2026-05-08",{"date":375,"type":40},"2026-05-13",{"date":377,"type":21},"2026-06",{"date":379,"type":21},"2029-03",{"name":381,"class":265},"Laguna Biotherapeutics, Inc.",{"id":383,"slug":384,"hasResults":12,"nctId":385,"briefTitle":386,"officialTitle":387,"acronym":4,"eligibilityCriteria":388,"healthyVolunteers":12,"sex":17,"minAge":389,"maxAge":4,"enrollmentInfo":390,"targetDuration":4,"studyType":145,"phases":4,"briefSummary":392,"conditions":393,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":400,"lastUpdatePostDateStruct":401,"startDateStruct":403,"completionDateStruct":405,"leadSponsor":407,"locationsCount":48},"100635977","a-real-world-study-on-the-efficacy-and-safety-of-menin-inhibitors-as-maintenance-after-allo-hsct-100635977","NCT07559695","A Real-world Study on the Efficacy and Safety of Menin Inhibitors as Maintenance After Allo-HSCT","A Real-world Study on the Efficacy and Safety of Menin Inhibitors as Maintenance Therapy After Allogeneic Hematopoietic Stem Cell Transplantation","Inclusion Criteria:\n\n1. Age ≥ 15 years.\n2. Patients diagnosed with acute leukemia (including AML, ALL, and MPAL) according to the World Health Organization (WHO 2022) criteria.\n3. Must meet one of the following characteristics: a. Harboring an NPM1 gene mutation (without concurrent FLT3-ITD or FLT3-TKD mutation); b. Harboring a KMT2A gene rearrangement or KMT2A-PTD; c. Harboring a NUP98 gene rearrangement; d. Other acute leukemia subtypes dependent on the menin-KMT2A interaction, if evidenced, may be enrolled upon discussion with and approval from the principal research team.\n4. Has undergone allogeneic hematopoietic stem cell transplantation (allo-HSCT), with ≥ 30 days elapsed since the date of graft infusion.\n5. Received menin inhibitor maintenance therapy after allo-HSCT and meets the following conditions: a. Received at least ≥ 2 complete cycles (7 days per cycle) of menin inhibitor therapy, or cumulative medication duration ≥ 14 days; b. Patient was in a state of CR\u002FCRh\u002FCRi at the initiation of maintenance therapy.\n6. No evidence of leukemia relapse during menin inhibitor maintenance therapy, defined as: a. Bone marrow blasts \\\u003C 5%, and blasts do not exhibit morphological features of acute leukemia (e.g.Auer rods); b. No evidence of extramedullary leukemia (e.g. CNS leukemia or myeloid sarcoma).\n7. The menin inhibitors used include but are not limited to: Revumenib, BN104, Ziftomenib, HMPL-506, or other menin-KMT2A interaction inhibitors.\n8. Capable of understanding and voluntarily signing the informed consent form.\n9. Complete clinical data.\n\nExclusion Criteria:\n\n1. Presence of any of the following at the initiation of menin inhibitor maintenance therapy (including within 28 days prior to starting treatment): a. Morphologic relapse in bone marrow (bone marrow blasts ≥ 5%); b. Presence of leukemic cells in peripheral blood.\n2. Active infection that is deemed uncontrolled by the investigator.\n3. Severe organ dysfunction, including: a. Hepatic impairment: ALT or AST ≥ 5 × ULN (Upper Limit of Normal), or total bilirubin ≥ 3 × ULN; b. Severe renal impairment: eGFR \\\u003C 30 ml\u002Fmin\u002F1.73 m²; c. Cardiac dysfunction: NYHA (New York Heart Association) Class III-IV.\n4. Concurrent acute graft-versus-host disease (aGVHD) ≥ Grade 2 or chronic graft-versus-host disease (cGVHD) ≥ Grade 3, requiring corticosteroids ≥ 1 mg\u002Fkg and ≥ 3 types of immunosuppressive therapy (including CNI, ruxolitinib, belumosudil, etc.).\n5. History of other malignancies requiring ongoing treatment (except for malignancies that have undergone curative treatment or are assessed to be in complete remission and require no systemic maintenance therapy or radiotherapy).\n6. Any gastrointestinal disorder that may affect the intake or absorption of oral medications (e.g.dysphagia, gastroparesis, uncontrolled chronic diarrhea, intestinal GVHD, etc).\n7. Patients deemed unsuitable for inclusion in this study by the investigator.\n8. Severely missing clinical data, precluding efficacy or safety assessment.\n9. Receipt of other maintenance therapies, including but not limited to hypomethylating agents, donor lymphocyte infusion (DLI), or other specific small-molecule targeted drugs.","15 Years",{"count":391,"type":21},20,"The objective of this observational study is to evaluate the efficacy and safety of menin inhibitor maintenance therapy in patients with acute leukemia who have undergone allogeneic hematopoietic stem cell transplantation (allo-HSCT).\n\nEligible patients will receive menin inhibitor maintenance therapy as part of their routine clinical practice. Acceptable agents include, but are not limited to, Revumenib, BN104, Ziftomenib, HMPL-506, or other menin-KMT2A interaction inhibitors. This study imposes no additional interventions on clinical management. The specific menin inhibitor, initiation timing, dose adjustments, and treatment duration are determined at the investigator's discretion based on the patient's individual condition and clinical circumstances.\n\nPatients will enter the follow-up phase upon initiation of menin inhibitor maintenance therapy. Efficacy and safety will be assessed at every cycle during the treatment period. Following the completion of treatment, survival follow-up visits will be conducted every three cycles. The primary endpoint is 2-year relapse-free survival rate since enrollment. The secondary endpoints included overall survival, event-free survival, cumulative incidence of relapse, non relpase related mortality and safety.",[394,29,395,396,397,398,399],"Menin Inhibitors","Post Hematopoietic Stem Cell Transplantation","Maintenance Therapy","KMT2A Rearrangement","NPM1 Mutation","NUP98 Gene Rearrangement","2026-04-24",{"date":402,"type":40},"2026-04-30",{"date":404,"type":40},"2025-11-01",{"date":406,"type":21},"2029-12-31",{"name":408,"class":47},"The First Affiliated Hospital of Soochow University",{"id":410,"slug":411,"hasResults":12,"nctId":412,"briefTitle":413,"officialTitle":414,"acronym":415,"eligibilityCriteria":416,"healthyVolunteers":12,"sex":17,"minAge":327,"maxAge":417,"enrollmentInfo":418,"targetDuration":4,"studyType":22,"phases":420,"briefSummary":421,"conditions":422,"keywords":423,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":400,"lastUpdatePostDateStruct":427,"startDateStruct":429,"completionDateStruct":431,"leadSponsor":433,"locationsCount":48},"100631368","benefits-of-formalized-care-support-program-following-acute-leukemia-diagnosis-100631368","NCT07499765","Benefits of Formalized Care Support Program Following Acute Leukemia Diagnosis","Benefits of Formalized Care Support Program Following an Annoucement of Acute Leukemia Diagnosis","ANX-LA","Inclusion Criteria:\n\n* informed consent signed\n* medical confirmation of acute leukemia diagnosis\n* age equal of superior to 26 years and under 80 years\n* confirmed diagnosis not yet treated\n* hospitalization at Centre Henri Becquerel\n* member or beneficiary of a social security\n\nExclusion Criteria:\n\n* -Patient unable to understand the study for any reason or to comply with the trial's requirements\n* Patient in relapse of acute leukemia\n* Patient diagnosed with acute myeloid leukemia 3\n* History of cancer within the 5 years preceding the year of study enrollment\n* Alcohol and drug abuse\n* Inclusion in another therapeutic trial that prevents further enrollment in a trial evaluating quality of life or psychological well-being\n* Diagnosed psychiatric illness\n* Patient under guardianship, curatorship, or legal protection","80 Years",{"count":419,"type":21},110,[222],"The purpose of this study is to determine the impact on anxiety between patients with a period of care support following their announcement of an acute leukemia (AL) diagnosis and patients without this accompaniment.",[29],[424,425,426],"acute leukemia","anxiety","care support program",{"date":428,"type":40},"2026-04-29",{"date":430,"type":21},"2026-03-30",{"date":432,"type":21},"2029-04-15",{"name":434,"class":47},"Centre Henri Becquerel",{"id":436,"slug":437,"hasResults":12,"nctId":438,"briefTitle":439,"officialTitle":439,"acronym":4,"eligibilityCriteria":440,"healthyVolunteers":12,"sex":17,"minAge":251,"maxAge":441,"enrollmentInfo":442,"targetDuration":4,"studyType":22,"phases":444,"briefSummary":445,"conditions":446,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":448,"lastUpdatePostDateStruct":449,"startDateStruct":451,"completionDateStruct":453,"leadSponsor":455,"locationsCount":48},"100630889","phase-2-mt2025-35-allogeneic-hematopoietic-stem-cell-transplantation-using-reduced-intensity-conditioning-treosulfan-and-fludarabine-with-post-transplant-cytoxan-ptcy-for-the-treatment-of-hematological-diseases-100630889","NCT07493538","MT2025-35 Allogeneic Hematopoietic Stem Cell Transplantation Using Reduced Intensity Conditioning Treosulfan and Fludarabine, With Post-Transplant Cytoxan (PTCy) for the Treatment of Hematological Diseases","Inclusion Criteria:\n\n* Patients 2-75 years of age\n* ≤7 5 years of age: Karnofsky score ≥ 70% (≥ 16 years) or Lansky play score ≥ 50 (\\\u003C 16 years) with appropriate organ criteria as below (in other inclusion criteria)\n* 5\u002F6 or 6\u002F6 related donor, OR a 5-8\u002F8 HLA-A, B, C, DRB1 allele match unrelated donor, OR a haplotype (at least 5\u002F10) related donor\n* adequate liver (no decompensated liver failure, Child Pugh A, AST\u002FALT \\\u003C5X ULN) and renal function (creatinine \\\u003C2.0)\n* absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction ≥ 40%\n* DLCO FEV1, FVC ≥ 40% predicted, and absence of O2 requirement\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding\n* Evidence of untreated\u002Funcontrolled HIV infection\n* Untreated active serious infection\n* Active CNS malignancy\n* CML in blast crisis not in a complete remission by abnormal blast count.\n* Less than 3 months since prior myeloablative transplant","75 Years",{"count":443,"type":21},132,[60],"This is a Phase II study following subjects proceeding with Treosulfan (36g\u002Fm2) preparative regimen followed by a related, unrelated, or partially matched family donor stem cell infusion, with post-transplant cyclophosphamide (PTCy) at 40mg\u002Fkg, tacrolimus and MMF for GVHD prophylaxis.",[91,92,29,63,447],"Myelodysplastic Syndromes","2026-04-13",{"date":450,"type":40},"2026-04-16",{"date":452,"type":40},"2026-04-10",{"date":454,"type":21},"2035-03",{"name":105,"class":47},{"id":457,"slug":458,"hasResults":12,"nctId":459,"briefTitle":460,"officialTitle":461,"acronym":462,"eligibilityCriteria":463,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":464,"enrollmentInfo":465,"targetDuration":4,"studyType":22,"phases":467,"briefSummary":468,"conditions":469,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":448,"lastUpdatePostDateStruct":470,"startDateStruct":471,"completionDateStruct":473,"leadSponsor":475,"locationsCount":477},"100543519","phase-1-study-assessing-rlt-using-177lulu-pentixather-for-relapsedrefractory-cxcr4-acute-leukemia-100543519","NCT06356922","Study Assessing RLT Using [177Lu]Lu-PentixaTher for Relapsed\u002FRefractory CXCR4+ Acute Leukemia.","Phase I\u002FII Study Assessing Radioligand Therapy (RLT) Using [177Lu]Lu-PentixaTher for Relapsed\u002FRefractory CXCR4+ Acute Leukemia.","PENTILULA","Inclusion Criteria:\n\n* Age ≥ 18 years\n* AML\u002FALL (OMS) with \\>5% of blasts in bone marrow (with or without extramedullary localisation)\n* CXCR4+ (ratio \\>2\u002Fisotypic control) at the time of pre-inclusion\n* All previously treated AML\u002FALL patients who have experienced relapse or treatment failure with no alternative treatment\n* At least 15 days since previous treatment\n* Eastern Cooperative Oncology Group (ECOG) performance status \\\u003C 2\n* eGFR ≥ 50 ml\u002Fmin by MDRD or CKDEPI\n* ASAT or ALAT \\> 5 upper normal value (except in case of documented presence of leukemia in the liver)\n* Serum bilirubin ≤ 30 µmol\u002Fl\n* Negative pregnancy test documented prior to enrolment (for females of childbearing potential)\n* Agree to use an effective form of contraception with sexual partners throughout study participation (for female and male patients who are fertile)\n* No active cardiac dysfunction (LVEF \\> 45%)\n* DLCO \\>40%\n* Written informed consent\n* Be willing and able to comply with scheduled visits and study procedures\n* Affiliation with French social security system or beneficiary from such system\n\nExclusion Criteria:\n\n* Meningeal involvement\n* HIV positive\n* Active Hepatitis B or C\n* Active infection within 7 days of starting treatment\n* Previous or concurrent second malignancy except for adequately treated basal cell carcinoma of the skin, curatively treated in situ carcinoma of the cervix, curatively treated solid cancer, with no evidence of disease for at least 1 year\n* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule\n* Participation at the same time in another study in which investigational drugs are used\n* Patient with contra-indications to Rhu-EPO, Rhu-GCSF, allopurinol, rasburicase, anti-histamines and corticosteroids\n* Absence of written informed consent\n* Pregnant or child breast feeding woman\n* Patient under guardianship or trusteeship\n* Patient under judicial protection","100 Years",{"count":466,"type":21},21,[24,60],"CXCR4 inhibition may represent a new therapeutic strategy in acute leukemia (AL) patients, not only by increasing chemosensitivity but also by preventing relapse of the disease by disruption of the interaction of residual leukemic cells with the bone marrow niche. Radiolabeled CXCR4 ligands have been developed for PET imaging (68Ga-PentixaFor; INN: Gallium (68Ga) boclatixafortide) and radioligand therapy (RLT) (\\[177Lu\\]Lu-PentixaTher\u002F\\[90Y\\]Y-PentixaTher). \\[177Lu\\]Lu and \\[90Y\\]Y-PentixaTher have been tested in three multiple myeloma patients in named-patient use with a remarkable efficacy in 2 patients (Herrmann, 2016). Moreover, feasibility of CXCR4 PET imaging in AML was reported, providing a framework for future theranostic approaches targeting the CXCR4\u002FCXCL12-defined leukemia-initiating cell niche (Herhaus, 2016).\n\nHere a Phase I\u002FII study to determine maximal tolerated dose (MTD) of a RLT using \\[177Lu\\]Lu-PentixaTher in relapsed\u002Frefractory AL was designed. This will be a standard phase I\u002FII 3+3 dose escalation study. Five dose levels will be tested, so 6 to 21 patients have to be included in the study.",[29],{"date":450,"type":40},{"date":472,"type":40},"2024-10-22",{"date":474,"type":21},"2027-10-22",{"name":476,"class":47},"Nantes University Hospital",4,{"id":479,"slug":480,"hasResults":12,"nctId":481,"briefTitle":482,"officialTitle":483,"acronym":4,"eligibilityCriteria":484,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":485,"targetDuration":4,"studyType":22,"phases":487,"briefSummary":488,"conditions":489,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":452,"lastUpdatePostDateStruct":497,"startDateStruct":499,"completionDateStruct":501,"leadSponsor":503,"locationsCount":505},"100516228","phase-1-safety-and-tolerability-of-ziftomenib-combinations-in-patients-with-relapsedrefractory-acute-myeloid-leukemia-100516228","NCT06001788","Safety and Tolerability of Ziftomenib Combinations in Patients With Relapsed\u002FRefractory Acute Myeloid Leukemia","Phase 1 Study to Determine the Safety and Tolerability of Ziftomenib Combinations for the Treatment of KMT2A-rearranged or NPM1-mutant Relapsed\u002FRefractory Acute Myeloid Leukemia","Key Inclusion Criteria:\n\n* Has been diagnosed with relapsed\u002Frefractory AML.\n* Has a documented NPM1 mutation or KMT2A rearrangement.\n* Has a documented FLT3 mutation (cA-3 only).\n* Has an Eastern Cooperative Oncology Group (ECOG) Performance status ≤ 2.\n* Has adequate hepatic and renal function as defined per protocol.\n* Has an ejection fraction above a protocol defined limit.\n* Participant, or legally authorized representative, must be able to understand and provide written informed consent prior to the first screening procedure.\n* Has agreed to use contraception as defined per protocol.\n\nKey Exclusion Criteria:\n\n* Has a diagnosis of acute promyelocytic leukemia or blast chronic myeloid leukemia.\n* Has clinically active central nervous system leukemia.\n* Has an active and uncontrolled infection.\n* Has a mean corrected QT interval (QTcF) \\> 480ms.\n* Has uncontrolled intercurrent illness, including, but not limited to protocol defined cardiac disease.\n* Has received radiation, chemotherapy, immunotherapy, or any other anticancer therapy including investigational therapy \\\u003C14 days or within 5 drug half-lives prior to the first dose of study intervention.\n* Has had major surgery within 4 weeks prior to the first dose of study intervention.\n* Has received a hematopoietic stem cell transplant (HSCT) and has not previously had adequate recovery per protocol defined criteria.\n* Has active graft-versus-host disease (GvHD) and or on immunosuppressive drugs for the treatment of GvHD\n* Participant is pregnant or lactating.",{"count":486,"type":21},171,[24],"The safety, tolerability, and antileukemic response of ziftomenib in combination with standard of care treatments for patients with relapsed\u002Frefractory acute myeloid leukemia will be examined with the following agents: FLAG-IDA, low-dose cytarabine, and gilteritinib.",[91,490,491,492,398,493,119,63,494,495,29,496],"AML With Mutated NPM1","Hematologic Malignancy","KMT2Ar","MLL Rearrangement","Leukemia, Myeloid","Leukemia, Myeloid, Acute","Neoplasms by Histologic Type",{"date":498,"type":40},"2026-04-14",{"date":500,"type":40},"2024-02-22",{"date":502,"type":21},"2027-08",{"name":504,"class":265},"Kura Oncology, Inc.",45,{"id":507,"slug":508,"hasResults":12,"nctId":509,"briefTitle":510,"officialTitle":511,"acronym":4,"eligibilityCriteria":512,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":513,"targetDuration":4,"studyType":22,"phases":515,"briefSummary":516,"conditions":517,"keywords":519,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":523,"lastUpdatePostDateStruct":524,"startDateStruct":526,"completionDateStruct":528,"leadSponsor":530,"locationsCount":48},"100577857","standard-of-care-reduced-intensity-conditioning-ric-with-200-versus-400-cgy-of-total-body-irradiation-tbi-in-patients-with-acute-leukemia-undergoing-first-allogeneic-blood-or-marrow-transplantation-bmt-100577857","NCT06803745","Standard-of-Care Reduced-Intensity Conditioning (RIC) With 200 Versus 400 cGy of Total Body Irradiation (TBI) in Patients With Acute Leukemia Undergoing First Allogeneic Blood or Marrow Transplantation (BMT)","A Randomized Phase II Trial of Standard-of-Care Reduced-Intensity Conditioning (RIC) With 200 Versus 400 cGy of Total Body Irradiation (TBI) in Patients With Acute Leukemia Undergoing First Allogeneic Blood or Marrow Transplantation (BMT)","Inclusion Criteria:\n\n1. Age ≥ 0 years\n2. Patients with a diagnosis of acute myeloid leukemia (AML), acute lymphoblastic leukemia or lymphoma (ALL), or acute leukemia of mixed or ambiguous lineage per the 2022 World Health Organization classifications,75,76 with \\\u003C 5% blasts on bone marrow morphologic analysis performed within 30 days of planned conditioning initiation\n\n   1. AML is generally defined as ≥ 20% myeloid blasts identified in the peripheral blood and\u002For bone marrow. Myeloid sarcoma is also recognized as an AML-defining entity. Situations in which AML can be diagnosed without a specific blast threshold met nor myeloid sarcoma present are when fusions involving RUNX1::RUNX1T1, CBFB::MYH11, DEK:NUP214, or RBM15::MRTFA are present; rearrangements involving KMT2A, MECOM, or NUP98 exist; or there is a mutation in NPM1.\n   2. B- or T-ALL is defined as the presence of lymphoid blasts identified in the peripheral blood and\u002For bone marrow with no specific blast threshold needed (acute lymphoblastic leukemia) or the presence of a lymphatic-based collection of lymphoblasts (acute lymphoblastic lymphoma).\n   3. Acute leukemia of mixed or ambiguous lineage is defined as mixed or ambiguous lineage blasts identified in the peripheral blood and\u002For bone marrow or the presence of a lymphatic-based collection (lymphoma) of mixed or ambiguous lineage blasts. A specific blast threshold does not need to be met.\n   4. Patients with a documented diagnosis of myeloproliferative neoplasm (MPN), myelodysplastic syndrome or neoplasm (MDS), and\u002For MDS\u002FMPN-overlap prior to diagnosis of acute leukemia may be included for randomization in this clinical trial so long as the patient has received at least 4 cycles of DNA methyltransferase inhibitor (e.g., azacitidine, decitabine, decitabine\u002Fcedazuradine (Inqovi), and\u002For any other agent that works via this mechanism) or at least one cycle of induction chemotherapy. A list of antecedent diagnoses per the World Health Organization 2022 classification of hematolymphoid tumors that pertain to this inclusion criterion are listed below 75\n\n      * i. MPN includes myelofibrosis, essential thrombocythemia, polycythemia vera, chronic neutrophilic leukemia, chronic eosinophilic leukemia, juvenile myelomonocytic leukemia, chronic myeloid leukemia (CML), or myeloproliferative neoplasm, not otherwise specified\n      * ii. Myelodysplastic syndrome or neoplasm (MDS)\n      * iii. MDS\u002FMPN-overlap includes chronic myelomonocytic leukemia (CMML), myelodysplastic\u002Fmyeloproliferative neoplasm with neutrophilia, myelodysplastic\u002Fmyeloproliferative neoplasm with SF3B1 mutation and thrombocytosis, or myelodysplastic\u002Fmyeloproliferative neoplasm, not otherwise specified\n      * iv. Of note, patients without a documented history of one of these conditions prior to diagnosis of acute myeloid leukemia with myelodysplastic features would not be restricted to this specific criterion for study inclusion.\n3. No active extramedullary leukemia or known active Central Nervous System (CNS) involvement by malignancy. Such disease treated into remission is permitted.\n4. Patients must have a related or unrelated bone marrow or peripheral blood donor\n\n   1. Human leukocyte antigen (HLA)-matched (10\u002F10) sibling donor (MSD)\n   2. HLA-matched (10\u002F10) unrelated donor (MUD)\n   3. HLA-haploidentical (5\u002F10) related donor (Haplo)\n   4. HLA-mismatched (5-9\u002F10) unrelated donor (mMUD)\n5. Planned allogeneic BMT using post-transplantation cyclophosphamide (PTCy) as a component of GVHD prophylaxis\n6. Adequate end-organ function as measured by:\n\n   1. Left ventricular ejection fraction greater than or equal to 35% or shortening fraction \\> 25%\n   2. Bilirubin ≤ 3.0 mg\u002FdL (unless due to Gilbert's syndrome or hemolysis), and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C 5 x Upper Limit of Normal (ULN)\n   3. Forced Expiratory Volume in one second (FEV1) and Forced Vital Capacity (FVC) \\> 40% of predicted\n7. Patients may enroll in other transplant-related trials (e.g., those testing post-transplant maintenance strategies or peri-transplant strategies for the management of donor specific antibodies) as long as other eligibility criteria are met and the requirements do not conflict with the treatment plan as outlined herein. Patients may also receive standard of care post-transplant maintenance therapies.\n\nExclusion Criteria:\n\n1\\) Acute leukemia with promyelocytic leukemia (PML)\u002Fretinoic acid receptor α (RARA) fusion 2)2) Documented, clinical diagnosis of myeloproliferative neoplasm (MPN), myelodysplastic syndrome or neoplasm (MDS), and\u002For MDS\u002FMPN-overlap based on the World Health Organization 2022 classification prior to diagnosis of acute leukemia.75 Patients with a diagnosis of AML with myelodysplastic features based on cytogenetic or genetic features and without an antecedent clinical history of MPN, MDS, and\u002For MDS\u002FMPN-overlap are not excluded.\n\n3\\) Prior allogeneic BMT 4) Eastern Cooperative Oncology Group (ECOG) Performance Status \\> 2 or Karnofsky\u002FLansky score \\\u003C 60 5) Patients with an additional active malignancy with a life expectancy \\\u003C 2 years due to that disease 6) Symptomatic coronary artery disease 7) Uncontrolled infection 8) Patients who are pregnant or breastfeeding 9) Body mass index (BMI) \\> 45 kg\u002Fm2",{"count":514,"type":21},160,[222],"This is a randomized phase II trial of standard-of-care reduced-intensity conditioning (RIC) with 200 versus 400 cGy of total body irradiation (TBI) in patients with acute leukemia undergoing first allogeneic blood or marrow Transplantation (BMT). The primary objective is to compare the rates of graft-versus-host disease-free and relapse-free survival (GRFS) between patients in the two cohorts.",[29,518],"Acute Lymphoblastic Lymphoma",[520,521,522],"stem cell transplant","bone marrow transplant","transplantation conditioning","2026-04-03",{"date":525,"type":40},"2026-04-06",{"date":527,"type":40},"2025-03-27",{"date":529,"type":21},"2030-09-30",{"name":531,"class":47},"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins",{"id":533,"slug":534,"hasResults":12,"nctId":535,"briefTitle":536,"officialTitle":537,"acronym":4,"eligibilityCriteria":538,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":56,"enrollmentInfo":539,"targetDuration":4,"studyType":22,"phases":541,"briefSummary":542,"conditions":543,"keywords":559,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":572,"lastUpdatePostDateStruct":573,"startDateStruct":574,"completionDateStruct":576,"leadSponsor":578,"locationsCount":48},"100495785","phase-2-mt2021-08t-cell-receptor-alphabeta-depletion-pbsc-transplantation-for-heme-malignancies-100495785","NCT05735717","MT2021-08T Cell Receptor Alpha\u002FBeta Depletion PBSC Transplantation for Heme Malignancies","Phase II, Open-Label, Prospective Study of T Cell Receptor Alpha\u002FBeta Depletion (A\u002FB TCD) Peripheral Blood Stem Cell (PBSC) Transplantation for Children and Adults With Hematological Malignancies","Inclusion Criteria:\n\n* Histological confirmation of hematological malignancies\n* Acute leukemias\n* Acute Myeloid Leukemia (AML) and related precursor neoplasms\n* Favorable risk AML is defined as having one of the following:\n* Acute lymphoblastic leukemia (ALL)\u002Flymphoma\n* Myelodysplasia (MDS) IPSS INT-2 or High Risk (i.e. RAEB, RAEBt) or Refractory Anemia with severe pancytopenia, transfusion dependence, or high risk cytogenetics or molecular features.\n* Age 60 years of age or younger at the time of consent\n* Karnofsky performance status ≥ 70% or Lansky play score 50% for ≤16 years of age.\n* Adequate organ function\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding.\n* Active uncontrolled infection within 1 week of starting preparative therapy\n* Known seropositive for HIV or known active Hepatitis B or C infection with detectable viral load by PCR.\n* Any prior autologous or allogeneic transplant\n* CML blast crisis\n* Active central nervous system malignancy",{"count":540,"type":21},70,[60],"This is a phase II, open-label, prospective study of T cell receptor alpha\u002Fbeta depletion (TCR α\u002Fβ TCD) peripheral blood stem cell (PBSC) transplantation for children and adults with hematological malignancies. This is a safety\u002Ffeasibility study of the investigational procedure\u002Fproduct.",[491,29,544,63,64,91,545,546,547,548,549,70,85,550,551,552,553,554,555,556,557,558,81,83],"Remission","TP53","Intrachromosomal Amplification of Chromosome 21","Cytogenetic Abnormality","CNS Leukemia","Minimal Residual Disease","Somatic Mutation","PTPN11 Gene Mutation","N-RAS Gene Amplification","Neurofibromatosis 1","NF1 Mutation","CBL Gene Mutation","Monosomy 7","Chromosome Abnormality","Fetal Hemoglobin",[560,561,562,563,564,565,566,567,568,569,570,571],"Bu","Flu","G-CSF","GFSR","aGVHD","HCT","MAC","Mel","PBSCT","PTLD","RECIST","TCR","2026-03-31",{"date":525,"type":40},{"date":575,"type":40},"2023-05-11",{"date":577,"type":21},"2030-11-30",{"name":105,"class":47},{"id":580,"slug":581,"hasResults":12,"nctId":582,"briefTitle":583,"officialTitle":584,"acronym":4,"eligibilityCriteria":585,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":441,"enrollmentInfo":586,"targetDuration":4,"studyType":22,"phases":588,"briefSummary":589,"conditions":590,"keywords":591,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":572,"lastUpdatePostDateStruct":594,"startDateStruct":595,"completionDateStruct":597,"leadSponsor":599,"locationsCount":48},"100376867","phase-2-bmt-06-study-of-intensity-modulated-total-marrow-irradiation-im-tmi-100376867","NCT04187105","BMT-06: Study of Intensity Modulated Total Marrow Irradiation (IM-TMI)","BMT-06: Phase II Study of Intensity Modulated Total Marrow Irradiation (IM-TMI) in Addition to Fludarabine\u002FCyclophosphamide and Post-Transplant Cyclophosphamide Conditioning for Partially HLA Mismatched Allogeneic Transplantation in Patients With Acute Leukemia and Myelodysplastic Syndrome (MDS)","Inclusion Criteria:\n\n1. Patient age 18-75 years\n2. Related donor who is, at minimum, Human Leukocyte Antigen (HLA) haploidentical or mismatched unrelated donor.\n\n   * Haploidentical: The donor and recipient must be identical in at least one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1, and HLA-DQB1. A minimum match of 4\u002F8 if using HLA-A,-B,-DRB1,-Cw, or 5\u002F10 if using HLA-A,-B,-Cw ,-DRB1, and -DQB1, will be considered evidence that the donor and recipient share one HLA haplotype.\n   * Unrelated donors: unrelated donors who are mismatched in one or more of the following loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1,HLA-DQB1- can be included with a maximum of 4\u002F8 or 5\u002F10 mismatches.\n3. Eligible diagnoses are listed below. Patient must have one of the following:\n\n   1. Relapsed or refractory acute leukemia (including AML or ALL in CR2 and primary refractory leukemia).\n   2. Poor-risk AML in first remission:\n\n      * AML arising from MDS or a myeloproliferative disorder, or secondary AML\n      * Poor risk molecular features including but not limited to presence of FLT3 internal tandem duplication mutation.\n      * Poor-risk cytogenetics: Monosomal karyotype, complex karyotype (\\> 3 abnormalities), inv(3), t(3;3), t(6;9), MLL rearrangement with the exception of t(9;11), or abnormalities of chromosome 5 or 7\n   3. Poor risk ALL in first remission:\n\n      * Poor risk cytogenetics: Philadelphia Chromosome, t(4;11), KMT2A translocation, t(8;14), complex karyotype (⩾ 5 chromosomal abnormalities) and low hypodiploidy (30-39 chromosomes)\u002Fnear triploidy (60-78 chromosomes)\n      * Philadelphia-like ALL\n      * Presentation WBC \\>30 × 109 for B-ALL or \\>100 109 for T-ALL\n      * Age\\>35\n      * Poor MRD clearance, defined as levels \\>1 × 10-3 after induction and levels \\>5 × 10-4 after early consolidation by flow cytometry\n   4. Myelodysplastic syndromes (MDS) with at least one of the following poor-risk features:\n\n      * i. Poor-risk cytogenetics (including but not limited to 7\u002F7q minus or complex cytogenetics)\n      * ii. IPSS score of INT-2 or greater\n      * iii. Treatment-related or Secondary MDS\n      * iv. MDS diagnosed before age 21 years\n      * v. Progression on or lack of response to standard DNA-methyltransferase inhibitor therapy\n      * vi. Life-threatening cytopenias, including those generally requiring greater than weekly transfusions\n      * vii. Poor risk molecular features including but not limited to the presence of BCOR, ASXL1, p53 or RUNX1 mutations\n   5. Mixed lineage and biphenotypic leukemia\n4. Adequate end-organ function as measured by:\n\n   * a. Left ventricular ejection fraction ≥ 40%\n   * b. Bilirubin ≤ 2.0 mg\u002FdL (unless due to Gilbert's syndrome or hemolysis), and ALT and AST \\\u003C 5 x ULN\n   * c. FEV1 and FVC \\> 50% of predicted\n\nExclusion Criteria:\n\n1. Presence of significant co morbidity as shown by:\n\n   * a. Left ventricular ejection fraction \\\u003C 40%\n   * b. Bilirubin \\> 2.0 mg\u002FdL (unless due to Gilbert's syndrome or hemolysis), and ALT and AST \\> 5 x ULN\n   * c. FEV1 and FVC \\\u003C 50% of predicted or DLCO \\\u003C50% of predicted once corrected for anemia\n   * d. Karnofsky score \\\u003C70\n   * e. History of cirrhosis\n2. Patients unable to sign informed consent\n3. Patient who have previously received radiation to \\>20% of bone marrow containing areas (assessed by radiation oncology physician)",{"count":587,"type":21},27,[60],"This study is being done to see if the addition of a targeted form of radiation to standard conditioning regimen will increase the amount of cancer cells that are killed off in the bone marrow and reduce the chances that your disease may return. This description is called Intensity Modulated Total Marrow Irradiation (IM-TMI).",[29,92],[592,593],"Stem Cell Transplant","Half-matched (haploidentical) stem cell transplant",{"date":525,"type":40},{"date":596,"type":40},"2020-01-27",{"date":598,"type":21},"2026-12",{"name":600,"class":47},"University of Illinois at Chicago",{"id":602,"slug":603,"hasResults":12,"nctId":604,"briefTitle":605,"officialTitle":606,"acronym":607,"eligibilityCriteria":608,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":609,"targetDuration":4,"studyType":22,"phases":611,"briefSummary":612,"conditions":613,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":614,"lastUpdatePostDateStruct":615,"startDateStruct":617,"completionDateStruct":619,"leadSponsor":620,"locationsCount":623},"100379776","emotion-and-symptom-focused-engagement-trial-for-individuals-with-acute-leukemia-100379776","NCT04224974","Emotion and Symptom-Focused Engagement Trial for Individuals With Acute Leukemia","Emotion and Symptom-Focused Engagement (EASE): A Multi-Site Randomized Controlled Trial of an Intervention for Individuals With Acute Leukemia","EASE","Inclusion Criteria:\n\n* Newly diagnosed AL (acute myeloid leukemia (AML) and acute lymphocytic leukemia (ALL) chronic myelogenous leukemia (CML) in blast crisis; T-cell leukemia lymphoma (TLL), and AL of ambiguous lineage) and is recruited up to 1 week prior to hospital admission or within 2 weeks of hospital admission. For patients diagnosed with a mixed phenotype AL, the dominant sub-type must be identified for stratification purposes.\n* Receiving or expected to receive induction therapy with curative intent at the time of recruitment.\n* Age ≥ 18 years.\n* Ability to pass the cognitive screening test at the time of recruitment (Short Orientation-Memory-Concentration Test (SOMC) score ≥ 20), unless deemed suitable at the CRA's discretion (e.g. in extenuating circumstances such as interruptions during the administration of the measure or when patients report a learning disability that can influence the results).\n* Patient is fluent in English and is able (i.e. sufficiently literate and competent) and willing to complete the baseline questionnaires in English. Ability but unwillingness to complete the baseline questionnaires will make the patient ineligible.\n\nExclusion Criteria:\n\n* Major communication difficulties at the time of recruitment, as assessed by the research team (e.g. severe hearing impairment or inability to speak).\n* Receiving on-site (in hospital) psychological\u002Fpsychiatric counseling at the time of recruitment.\n* Receiving on-site (in hospital) palliative care services at the time of recruitment.\n* A diagnosis of acute promyelocytic leukemia.",{"count":610,"type":21},266,[222],"The purpose of this study is to find out whether a novel manualized intervention, called Emotion and Symptom-focused Engagement (EASE), that combines psychological support with symptom screening plus triggered referral to early palliative care for symptom control, reduces psychological distress and physical symptom burden in individuals newly diagnosed with acute leukemia. To do this, half of the participants in this study will receive the usual care offered to patients with acute leukemia and half of the participants will receive usual care plus the EASE intervention.",[29],"2026-03-24",{"date":616,"type":40},"2026-03-27",{"date":618,"type":40},"2022-01-06",{"date":317,"type":21},{"name":621,"class":622},"Canadian Cancer Trials Group","NETWORK",5,{"id":625,"slug":626,"hasResults":12,"nctId":627,"briefTitle":628,"officialTitle":629,"acronym":4,"eligibilityCriteria":630,"healthyVolunteers":12,"sex":17,"minAge":631,"maxAge":4,"enrollmentInfo":632,"targetDuration":4,"studyType":22,"phases":634,"briefSummary":635,"conditions":636,"keywords":638,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":642,"lastUpdatePostDateStruct":643,"startDateStruct":645,"completionDateStruct":647,"leadSponsor":649,"locationsCount":48},"100613759","phase-1-by002-iit-study-in-rr-acute-leukemia-100613759","NCT07270770","BY002 IIT Study in R\u002FR Acute Leukemia","A Single-center, Open-label, Investigator-Initiated Trial to Evaluate the Safety, Pharmacokinetics, and Efficacy of Menin Inhibitor BY002 in Patients With Relapsed or Refractory Acute Leukemia","Inclusion Criteria:\n\n* Age ≥16 years.\n* Confirmed diagnosis of AML, ALL, or MPAL per WHO 2022 criteria.\n* Relapsed or refractory disease after ≥1 prior therapy.\n* Presence of KMT2A rearrangement or NPM1 mutation (preferred, but not exclusive).\n* ECOG performance status 0-2.\n* Adequate organ function:\n* ANC ≥1.0 × 10⁹\u002FL (unless cytopenia due to leukemia)\n* Platelets ≥50 × 10⁹\u002FL (unless due to leukemia)\n* ALT\u002FAST ≤2.5 × ULN, bilirubin ≤1.5 × ULN\n* Creatinine clearance ≥50 mL\u002Fmin\n* Negative pregnancy test for women of childbearing potential.\n* Willing to use effective contraception during study and 90 days after last dose.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Active central nervous system (CNS) leukemia. (Prior CNS involvement allowed if treated and controlled; CNS prophylaxis permitted.)\n* History of significant liver disease, including viral hepatitis or cirrhosis:\n* HBsAg positive must have negative HBV DNA.\n* HCV antibody positive must have negative HCV RNA.\n* Known HIV infection.\n* Pregnant or breastfeeding women.\n* Significant cardiac disease:\n* Congenital long QT syndrome or QTcF \\>450 msec.\n* Acute myocardial infarction, unstable angina, or coronary artery bypass within 6 months.\n* Congestive heart failure ≥ NYHA class II.\n* History of another malignancy within 5 years, except adequately treated basal cell carcinoma of the skin, in-situ breast cancer, or in-situ cervical cancer.\n* Autologous HSCT or CAR-T therapy within 60 days, or unresolved toxicities from ASCT\u002FCAR-T.\n* Allogeneic HSCT within 100 days, or active GVHD, or requiring ongoing immunosuppressive therapy.\n* Anti-leukemia therapy within 2 weeks before study entry (hydroxyurea permitted).\n* Prior investigational drug use: \\\u003C2 weeks or \\\u003C5 half-lives for small molecules; \\\u003C4 weeks or \\\u003C5 half-lives for biologics (whichever is shorter).\n* Unresolved toxicities \\> grade 1 from prior anti-leukemia therapy (except alopecia).\n* Uncontrolled active infection:\n* Mild infections manageable with oral\u002Ftopical treatment are allowed.\n* Serious infections requiring hospitalization\u002FIV antibiotics within 14 days excluded, unless resolved.\n* Febrile neutropenia without infection evidence may be eligible if afebrile \\>72 h without antipyretics.\n* Active tuberculosis excluded.\n* Conditions impairing oral intake or absorption (e.g., swallowing difficulty, short bowel syndrome, gastroparesis).\n* Known severe allergy to Menin inhibitors or any component of BY002.\n* Investigator judges poor compliance or inability to complete study.\n* Any other serious disease, abnormality, or condition that may increase risk, interfere with study drug, confound results, or expected survival ≤6 months.","16 Years",{"count":633,"type":21},18,[24],"This is a single-center, open-label, investigator-initiated phase 1 study designed to evaluate the safety, pharmacokinetics (PK), and preliminary efficacy of the menin inhibitor BY002 in patients with relapsed or refractory acute leukemia. Eligible subjects include adult patients (≥18 years) with AML, ALL, or MPAL, excluding APL, who carry KMT2A rearrangement or NPM1 mutation and have no better treatment options.\n\nThe study will be conducted in a dose-escalation design (3+3) , followed by expansion at the recommended dose. BY002 is administered orally in 28-day cycles until disease progression, unacceptable toxicity, HSCT, withdrawal, or death.\n\nThe primary objectives are to determine the incidence of dose-limiting toxicities (DLTs) and serious adverse events (SAEs), and to define the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D). Secondary objectives include characterization of PK parameters, evaluation of safety (AEs, laboratory tests, vital signs, ECG), and assessment of efficacy endpoints such as complete remission (CR), composite remission (CRc), overall response rate (ORR), duration of response (DOR), event-free survival (EFS), relapse-free survival (RFS), overall survival (OS), and cumulative incidence of relapse (CIR). Exploratory objectives include analysis of pharmacodynamic biomarkers (e.g., HOXA9, MEIS1, CD11b) and correlation of baseline genetic mutations (e.g., NPM1, KMT2A, FLT3, TP53, NUP98) with clinical outcomes.",[29,637],"KMT2A Rearrangements or NPM1 Mutations Acute Leukemia",[639,640,641],"KMT2A rearrangements or NPM1 mutations","relapsed or refractory acute leukemia","Menin Inhibitor","2026-03-16",{"date":644,"type":40},"2026-03-18",{"date":646,"type":40},"2026-03-15",{"date":648,"type":21},"2027-07-31",{"name":408,"class":47},{"id":651,"slug":652,"hasResults":12,"nctId":653,"briefTitle":654,"officialTitle":655,"acronym":4,"eligibilityCriteria":656,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":657,"targetDuration":4,"studyType":22,"phases":659,"briefSummary":660,"conditions":661,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":642,"lastUpdatePostDateStruct":663,"startDateStruct":664,"completionDateStruct":666,"leadSponsor":668,"locationsCount":670},"100532001","phase-1-a-study-to-investigate-lp-118-ponatinib-vincristine-and-dexamethasone-in-relapsedrefractory-acute-lymphoblastic-leukemia-all-or-lymphoblastic-lymphoma-lbl-100532001","NCT06207123","A Study to Investigate LP-118, Ponatinib, Vincristine and Dexamethasone in Relapsed\u002FRefractory Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LBL)","A Phase I\u002FII Study to Investigate the Combination of LP-118, Ponatinib, Vincristine and Dexamethasone in Relapsed\u002FRefractory T-ALL\u002FLBL","Inclusion Criteria:\n\n1. Relapsed or refractory patients with T-lineage acute lymphoblastic leukemia or T-lymphoblastic lymphoma\n2. 18 years old or older\n3. Bone marrow or peripheral blood involvement with ≥5% lymphoblasts or measurable residual disease with \\>10-4 level detected by multiparameter flow cytometry or next-generation sequencing (NGS)-based measurable residual disease (ClonoSEQ, Adaptive Technologies). Patients with isolated extramedullary disease that is measurable by computed tomography (CT) scan are also eligible.\n4. Eastern Cooperative Oncology Group performance status 0-2.\n5. Adequate organ function as defined by all of the following:\n\n   1. Creatinine clearance ≥50 mL\u002Fmin, determined by the Cockroft-Gault formula, or measured by a 24-hour urine collection.\n   2. Aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 x upper limit of normal (ULN) and bilirubin ≤1.5 x ULN (unless considered due to Gilbert's syndrome or of non-hepatic origin i.e,, leukemic involvement). For patients with Gilbert's syndrome, bilirubin ≤1.5 x of their baseline bilirubin level will be required.\n6. Participants must be at least 2 weeks from major surgery or radiation therapy. A wash-out period of 4 half-lives is required for patients who participated in other investigational trials. These patients must have recovered from clinically significant toxicities related to these prior treatments.\n7. Participants must voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC)\u002FInstitutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures.\n8. Females of childbearing potential will use effective contraception during protocol treatment and for at least 8 months after the last dose. Males with female partners of reproductive potential will use effective contraception during protocol treatment and for at least 5 months after the last dose. A patient is of childbearing potential if, in the opinion of the treating investigator, he\u002Fshe is biologically capable of having children and is sexually active. Female patients who are not of childbearing potential (ie, meet at least one of the following criteria):\n\n   a. Have undergone hysterectomy or bilateral oophorectomy; or have medically confirmed ovarian failure; or are medically confirmed to be post-menopausal (cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause).\n9. Participants who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.\n\nExclusion Criteria:\n\n1. Active central nervous system (CNS) leukemia\n2. Active or chronic hepatitis B or C infection as evidenced by hepatitis B surface antigen and anti-hepatitis C antibody positivity, respectively, or known seropositivity for human immunodeficiency virus (HIV). Patients with HIV but an undetectable viral load are eligible for enrollment.\n3. Major surgery within \\\u003C2 weeks before randomization.\n4. Unstable or severe uncontrolled medical condition (eg, unstable cardiac function or unstable pulmonary condition.\n5. Concurrent active malignancy other than non-melanoma skin cancer, carcinoma in situ of the cervix, or localized prostate cancer that has been definitely treated with radiation or surgery. Patients with previous malignancies are eligible provided that they have been disease free for ≥2 years or are not currently requiring treatment.\n6. Uncontrolled cardiac disease.\n7. Pregnant females; breastfeeding females; males with female partners of reproductive potential and females of childbearing potential not using highly effective contraception or not agreeing to continue highly effective contraception for a minimum of 5 months after the last dose of investigational product if male and 8 months after the last dose of investigational product if female.\n8. Participation in other investigational studies during active treatment phase.\n9. Other severe acute, chronic medical, psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the treating physician, would make the patient inappropriate for entry into this study.",{"count":658,"type":21},15,[24,60],"The purpose of this study is to learn more about LP-118 (an experimental drug) and its side effects and decide on acceptable doses. The purpose of this study is to determine if LP-118 can be given safely with another medicine called ponatinib, that is FDA-approved for the treatment of acute lymphoblastic leukemia.",[29,662,81],"Lymphoblastic Leukemia",{"date":644,"type":40},{"date":665,"type":40},"2024-09-13",{"date":667,"type":21},"2026-12-01",{"name":669,"class":47},"University of Chicago",2,{"id":672,"slug":673,"hasResults":12,"nctId":674,"briefTitle":675,"officialTitle":676,"acronym":4,"eligibilityCriteria":677,"healthyVolunteers":12,"sex":17,"minAge":678,"maxAge":56,"enrollmentInfo":679,"targetDuration":4,"studyType":22,"phases":681,"briefSummary":682,"conditions":683,"keywords":684,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":688,"lastUpdatePostDateStruct":689,"startDateStruct":691,"completionDateStruct":693,"leadSponsor":694,"locationsCount":695},"100360206","phase-2-graft-versus-host-disease-reduction-strategies-for-donor-blood-stem-cell-transplant-patients-with-acute-leukemia-or-myelodysplastic-syndrome-mds-100360206","NCT03970096","Graft Versus Host Disease-Reduction Strategies for Donor Blood Stem Cell Transplant Patients With Acute Leukemia or Myelodysplastic Syndrome (MDS)","A Phase II Randomized Controlled Trial Comparing GVHD-Reduction Strategies for Allogeneic Peripheral Blood Transplantation (PBSCT) for Patients With Acute Leukemia or Myelodysplastic Syndrome: Selective Depletion of CD45RA+ Naïve T Cells (TND) vs. Post-Transplantation Cyclophosphamide (PTCy)","Inclusion Criteria:\n\n* Patients who are considered appropriate candidates for myeloablative, TBI-containing allogeneic hematopoietic stem cell transplantation and have one of the following diagnoses:\n\n  * Acute lymphocytic leukemia (ALL) in first or subsequent morphological remission (\\\u003C 5% marrow blasts by morphology).\n  * Acute myeloid leukemia (AML) in first or subsequent morphological remission (\\\u003C 5% marrow blasts by morphology).\n  * Other acute leukemia or related neoplasm (including but not limited to 'mixed phenotype' 'biphenotypic', 'acute undifferentiated' or 'ambiguous lineage' acute leukemia, blastic plasmacytoid dendritic cell neoplasm, lymphoblastic lymphoma, Burkitt leukemia\u002Flymphoma, mast cell leukemia, chronic myeloid leukemia \\[CML\\] with blast crisis or other chronic myeloproliferative neoplasm) in first or subsequent morphological remission (\\\u003C5% marrow blasts by morphology).\n  * Myelodysplastic syndrome (MDS) with a history of excess blasts (≥ approximately 5% in marrow blasts by morphology) and a history of receiving cytoreductive therapy (including but not limited to BCL-2 inhibitors or cytotoxic chemotherapy) within the past 3 months.\n* Patient age 1-60 years old (inclusive) at the time of informed consent\n\n  * Patients aged 1-50 years old (inclusive) are eligible for TBI-based conditioning regimens.\n  * Patients aged 1-60 years old (inclusive) are eligible for busulfan-based conditioning regimens (with or without TBI 4 Gy).\n* Patient with an HLA-matched (HLA-A, B, C, DRB1, and DQB1 matched) related or unrelated donor capable of donating PBSC.\n* Recipient informed consent\u002Fassent and\u002For legal guardian permission must be obtained.\n* DONOR: HLA-matched related and unrelated donors (HLA-A, B, C, DRB1 and DQB1 matched based on high-resolution typing).\n* DONOR: \\>= 18 years old.\n* DONOR: Willing to donate PBSC.\n* DONOR: Matched related donors:\n\n  * Must give informed consent using the related donor informed consent form.\n  * Must meet institutional donor eligibility criteria or be ineligible with statement that the donor is a first or second degree relative (exception 21 Code of Federal Regulations \\[CFR\\] 1271.65(b)(i)).\n* DONOR: Matched unrelated donors:\n\n  * Must consent according to the 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\nExclusion Criteria:\n\n* Patients with central nervous system (CNS) involvement refractory to intrathecal chemotherapy and\u002For standard cranial-spinal radiation. A patient may have a history of CNS disease. However, any CNS disease must be cleared by the end of the pre-conditioning evaluation time frame. If CNS disease is identified on 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 prevention of GVHD.\n* Patient weight:\n\n  * Patients with HLA-matched related donors will be excluded if they weigh \\>= 110 kg.\n  * Patients with HLA-matched unrelated donors will be excluded if they weigh \\>= 110 kg and must be discussed with the Fred Hutch protocol principal investigator (PI) if they weigh \\>= 90 kg.\n* Patients who are positive for human immunodeficiency virus (HIV)-1, HIV-2, human T-cell lymphotropic virus (HTLV)1 or HTLV2.\n* Patients with uncontrolled infections for whom myeloablative HCT is considered contraindicated by the consulting infectious disease physician; i.e. patients with active infections require infectious disease consultation and documentation by the infectious disease team that myeloablative HCT is not considered to be contraindicated. Upper respiratory tract infection is not considered to represent an uncontrolled infection in this context.\n* Patients with organ dysfunction, including:\n\n  * Renal insufficiency (creatinine \\> 1.5 mg\u002Fdl) at the time of evaluation for the protocol. Patients with a known history of creatinine \\> 1.5 mg\u002Fdl or a current serum creatinine above the normal range for age must have a current creatinine clearance of \\> 60 ml\u002Fmin\u002F1.73 m\\^2 (measured by 24-hr urine specimen or nuclear glomerular filtration rate \\[GFR\\]).\n  * Left ventricular ejection fraction \\\u003C 45%.\n  * Carbon monoxide diffusing capability (DLCO) corrected \\\u003C 60%. Patients who are unable to perform pulmonary function tests (for example, due to young age and\u002For developmental status) will be excluded if the oxygen (O2) saturation is \\\u003C 92% on room air.\n  * Liver function abnormality. Patients who have liver function test (LFT)s (specifically, total bilirubin, aspartate aminotransferase \\[AST\\] or alanine aminotransferase \\[ALT\\]) \\>= twice the upper limit of normal should be evaluated by a gastrointestinal (GI) physician unless there is a clear precipitating factor (such as an azole, MTX, trimethoprim-sulfamethoxazole, or another drug). If the GI physician considers that HCT on the protocol is contraindicated, that patient will be excluded from the protocol. Patients with Gilbert's syndrome require GI physician consultation but may be included on the protocol. Patients with no other known liver function abnormality or with reversible drug-related transaminitis do not necessarily require GI consultation and may be included on the protocol.\n* Patients who have received previous myeloablative allogeneic or autologous transplantation.\n* Patients with a life expectancy \\\u003C 12 months from co-existing disease other than the leukemia or MDS.\n* Patients who are pregnant or breast-feeding.\n* Patients of childbearing age who are presumed to be fertile and are unwilling to use an effective birth control method or refrain from sexual intercourse during and for 12 months post-HCT.\n* Patients with any other significant medical conditions that would make them unsuitable for transplantation, as determined by the PI.\n* Patients with a known hypersensitivity to tacrolimus or MTX\n* Patients who have received checkpoint inhibitors within three months of transplantation unless an exception is made by the PI\n* DONOR: Donors who are HIV-1, HIV-2, HTLV-1, HTLV-2 seropositive or with active hepatitis B or hepatitis C virus infection. Test must be performed using Food and Drug Administration (FDA) licensed, cleared, and approved test kits (serological and\u002For nucleic acid amplification test \\[NAT\\] and\u002For other approved testing) in a Clinical Laboratory Improvement Act (CLIA)-certified laboratory.\n* Unrelated donors donating outside of the USA.","1 Year",{"count":680,"type":21},120,[60],"This phase II trial investigates two strategies and how well they work for the reduction of graft versus host disease in patients with acute leukemia or MDS in remission. Giving chemotherapy and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. It may also 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. The donated stem cells may also replace the patient's immune cells and help destroy any remaining cancer cells.",[29,64,63,285,345],[685,686,687],"Lymphoid Leukemia","Myeloid and Monocytic Leukemia","Other Hematopoietic","2026-03-10",{"date":690,"type":40},"2026-03-12",{"date":692,"type":40},"2019-11-19",{"date":406,"type":21},{"name":298,"class":47},3,{"id":697,"slug":698,"hasResults":12,"nctId":699,"briefTitle":700,"officialTitle":701,"acronym":4,"eligibilityCriteria":702,"healthyVolunteers":12,"sex":17,"minAge":251,"maxAge":4,"enrollmentInfo":703,"targetDuration":4,"studyType":22,"phases":704,"briefSummary":705,"conditions":706,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":711,"lastUpdatePostDateStruct":712,"startDateStruct":714,"completionDateStruct":716,"leadSponsor":718,"locationsCount":48},"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",{"count":587,"type":21},[24],"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.",[29,334,64,63,707,708,709,710],"Childhood Acute Leukemia","Childhood Acute Leukemia of Ambiguous Lineage","Childhood Acute Lymphoblastic Leukemia","Childhood Acute Myeloid Leukemia","2026-03-03",{"date":713,"type":40},"2026-03-05",{"date":715,"type":40},"2024-12-06",{"date":717,"type":21},"2028-04-29",{"name":719,"class":47},"City of Hope Medical Center",{"id":721,"slug":722,"hasResults":12,"nctId":723,"briefTitle":724,"officialTitle":724,"acronym":4,"eligibilityCriteria":725,"healthyVolunteers":12,"sex":17,"minAge":678,"maxAge":4,"enrollmentInfo":726,"targetDuration":4,"studyType":22,"phases":728,"briefSummary":729,"conditions":730,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":735,"lastUpdatePostDateStruct":736,"startDateStruct":737,"completionDateStruct":739,"leadSponsor":741,"locationsCount":48},"100627234","chemogenomic-profiling-in-hematological-malignancies-hem-profiling-2021-100627234","NCT07445984","Chemogenomic Profiling in Hematological Malignancies (HEM-Profiling 2021)","Inclusion Criteria:\n\n* Patient aged \\>1 year old, referred for evaluation to the University Hospital of Parma;\n* Retrospective study: previously patients with hematological malignancies;\n* Prospective study: 1) patients with clinical suspect of hematological malignancies which requires a diagnostic assessment using peripheral blood drawn, bone marrow aspirate\u002Fbiopsy, lymph nodes biopsies or biopsies of tissues with metastatic involvement including liquor from rachicentesis, tissue aspirate etc. 2) patients with clinical suspect of relapsed\u002Frefractory onco-hematological disorder, which requires a diagnostic assessment using bone marrow aspirate\u002Fbiopsy or biopsies of tissues with metastatic involvement including lymph nodes, liquor from rachicentesis, tissue aspirate etc. 3) patients that progress in blastic transformation from a chronic condition or suspect of relapsed\u002Frefractory hematological disease, which requires a diagnostic assessment using peripheral blood drawn, bone marrow aspirate\u002Fbiopsy, lymph nodes biopsies or biopsies of tissues with metastatic involvement including liquor from rachicentesis, tissue aspirate etc;\n* Written informed consent. Retrospective study: informed consent will be signed during the first follow-up visit.\n\nExclusion Criteria:\n\n* Age \\\u003C1 year old\n* Patients who are unable to provide informed consent prior to any procedure for any reason.",{"count":727,"type":21},250,[222],"The study will be conducted retrospectively and prospectively, using bone marrow (BM) or peripheral blood (PB) samples or biopsies of lymph nodes or tissues with metastatic involvement taken from previously stored samples here at the University Hospital of Parma or taken from patients that need to underwent diagnostic evaluation for a suspect or a defined diagnosis of hematological malignancies collected at the University Hospital of Parma.",[731,29,732,733,734],"Chronic Leukemia","Myeloproliferative Disorders","Lymphoproliferative Disorders","Myelodysplastic Disorders","2026-02-25",{"date":711,"type":40},{"date":738,"type":40},"2021-07-28",{"date":740,"type":21},"2026-07-28",{"name":742,"class":47},"Azienda Ospedaliero-Universitaria di Parma",{"id":744,"slug":745,"hasResults":12,"nctId":746,"briefTitle":747,"officialTitle":747,"acronym":748,"eligibilityCriteria":749,"healthyVolunteers":12,"sex":17,"minAge":251,"maxAge":4,"enrollmentInfo":750,"targetDuration":4,"studyType":22,"phases":752,"briefSummary":753,"conditions":754,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":735,"lastUpdatePostDateStruct":756,"startDateStruct":757,"completionDateStruct":759,"leadSponsor":761,"locationsCount":48},"100627192","feasibility-of-a-multi-omics-platform-for-hematological-malignancies-100627192","NCT07445438","Feasibility of a Multi-omics Platform for Hematological Malignancies","FOCUS","Inclusion Criteria:\n\n* Patient aged \\> 2 year old\n* Retrospective study:\n* Patients previously diagnosed with hematological malignancies\n* Prospective study:\n* Patients with clinical suspect of hematological malignancies requiring a diagnostic assessment using BM or PB samples, biopsies of lymph nodes or tissues with metastatic involvement, or other biological fluids (such as CSF, pathologic pleural effusion).\n* Patients with clinical suspicion of R\u002FR onco-hematological disorder, requiring a diagnostic assessment using BM aspirate\u002Fbiopsy or biopsies of tissues with metastatic involvement including lymph nodes, liquor from lumbar puncture, tissue aspirate etc.\n* Patients with blastic transformation from a chronic condition or suspect of R\u002FR hematological disease requiring a diagnostic assessment using PB drawn, BM aspirate\u002Fbiopsy, lymph nodes biopsies, or biopsies of tissues with metastatic involvement, including CSF from lumbar puncture, tissue aspirate, etc.\n\nExclusion Criteria:\n\n* Age \\\u003C2 year old\n* Patient without a diagnosis of hematological malignancy.",{"count":751,"type":21},1040,[222],"This is a biological study based on a collaborative effort involving several Italian haematology centres (including the coordinating centre). The study will be conducted retrospectively and prospectively using bone marrow (BM) or peripheral blood (PB) samples, lymph node or tissue biopsies with metastatic involvement, and other biological fluids, such as cerebrospinal fluid and pathological pleural effusion.",[755,731,29,732,733,734],"Myeloma Multiple",{"date":711,"type":40},{"date":758,"type":40},"2025-03-31",{"date":760,"type":21},"2030-03",{"name":742,"class":47}]