[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acute-myeloid-leukemia-in-remission\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acute-myeloid-leukemia-in-remission":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,57,92,120,149,171,216],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":40,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":49,"completionDateStruct":51,"leadSponsor":53,"locationsCount":56},"100337247","phase-1-211at-bc8-b10-followed-by-donor-stem-cell-transplant-in-treating-patients-with-relapsed-or-refractory-high-risk-acute-leukemia-or-myelodysplastic-syndrome-100337247",false,"NCT03670966","211At-BC8-B10 Followed by Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory High-Risk Acute Leukemia or Myelodysplastic Syndrome","A Phase I\u002FII Study Evaluating Escalating Doses of 211At-Labeled Anti-CD45 MAb BC8-B10 (211At-BC8-B10) Followed by Related Haplo-Identical Allogeneic Hematopoietic Cell Transplantation for High-Risk Acute Leukemia or Myelodysplastic Syndrome (MDS)","Inclusion Criteria:\n\n* Patients must have AML, ALL, high-risk MDS, or MPAL (also known as biphenotypic) meeting one of the following descriptions:\n\n  * AML, ALL, or MPAL in first remission with evidence of measurable residual disease (MRD) by flow cytometry;\n  * AML, ALL, or MPAL beyond first remission (i.e., having relapsed at least one time after achieving remission in response to a treatment regimen);\n  * AML, ALL, or MPAL representing primary refractory disease (i.e., having failed to achieve remission at any time following one or more prior treatment regimens);\n  * AML evolved from myelodysplastic or myeloproliferative syndromes;\n  * MDS expressed as refractory anemia with excess blasts (RAEB)\n  * Chronic myelomonocytic leukemia (CMML) by French-American-British (FAB) criteria.\n* Patients not in remission must have CD45-expressing leukemic blasts. Patients in remission do not require phenotyping and may have leukemia previously documented to be CD45 negative (because in remission patients, virtually all antibody binding is to non-malignant cells which make up \\>= 95% of nucleated cells in the marrow).\n* Patients must be \\>= 18 and =\\\u003C 75 years of age.\n* Patients should have a circulating blast count of less than 10,000\u002Fmm\\^3 (control with hydroxyurea or similar agent is allowed).\n* Patients must have an estimated creatinine clearance greater than 50\u002Fml per minute by the following formula (Cockcroft-Gault). Serum creatinine value must be within 28 days prior to registration.\n* Total bilirubin within normal limits\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C 2 times the upper limit of normal.\n* Eastern Cooperative Oncology Group (ECOG) \\\u003C 2 or Karnofsky \\>= 70.\n* Patients must be free of uncontrolled infection.\n* Patients with prior non-myeloablative or reduced-intensity conditioning allogeneic-HCT must have no evidence of ongoing GVHD and be off all immunosuppression for at least 6 weeks at time of enrollment.\n* Patients must have normal elastography.\n* If ferritin is elevated, patient must have less than 7 mg\u002Fg liver iron concentration on liver T2 magnetic resonance imaging (MRI).\n* Patients should have an official gastrointestinal (GI) consult prior to the transplant for full evaluation.\n* Patients must have a related donor who is identical for one HLA haplotype and mismatched at the HLA-A, -B or DRB1 loci of the unshared haplotype with the exception of single HLA-A, -B or DRB1 mismatches.\n* DONOR: Donors must meet HLA matching criteria as well as standard Seattle Cancer Care Alliance (SCCA) criteria for PBSC or bone marrow donation. Preference should be given to donors who are mismatched at the HLA-A, -B and -DRB1 loci.\n\nExclusion Criteria:\n\n* Patients may not have symptomatic coronary artery disease and may not be on cardiac medications for anti-arrhythmic or inotropic effects.\n* Left ventricular ejection fraction \\\u003C 45%.\n* Corrected diffusion capacity of the lung for carbon monoxide (DLCO) \\\u003C 35% or receiving supplemental continuous oxygen. When pulmonary function tests (PFTs) cannot be obtained, the 6-minute walk test (6MWT, also known as exercise oximetry) will be used: Any patient with oxygen saturation on room air of \\\u003C 89% during a 6MWT will be excluded\n* Liver abnormalities: fulminant liver failure, cirrhosis of the liver with evidence of portal hypertension, alcoholic hepatitis, esophageal varices, hepatic encephalopathy, uncorrectable hepatic synthetic dysfunction as evidenced by prolongation of the prothrombin time, ascites related to portal hypertension, bacterial or fungal liver abscess, biliary obstruction, chronic viral hepatitis, or symptomatic biliary disease.\n* Patients who are known to be seropositive for human immunodeficiency virus (HIV).\n* Perceived inability to tolerate diagnostic or therapeutic procedures.\n* Active central nervous system (CNS) leukemia at time of treatment.\n* Patients with prior myeloablative allogeneic-HCT.\n* Women of childbearing potential who are pregnant (beta human chorionic gonadotropin \\[B-HCG\\]+) or breast feeding.\n* Fertile men and women unwilling to use contraceptives during and for 12 months post-transplant.\n* Inability to understand or give an informed consent.\n* Allergy to murine-based monoclonal antibodies.\n* Known contraindications to radiotherapy.","ALL","18 Years","75 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This phase I\u002FII trial studies the side effects and best dose of a radioactive agent linked to an antibody (211At-BC8-B10) followed by donor stem cell transplant in treating patients with high-risk acute leukemia or myelodysplastic syndrome that has come back (recurrent) or isn't responding to treatment (refractory). 211At-BC8-B10 is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Giving chemotherapy and total body irradiation before a stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. When the healthy stem cells from a donor are infused into the patient, they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can attack the body's normal cells, called graft versus host disease. Giving cyclophosphamide, mycophenolate mofetil, and tacrolimus after a transplant may stop this from happening.",[28,29,30,31,32,33,34,35,36,37,38,39],"Acute Lymphoblastic Leukemia in Remission","Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome","Acute Myeloid Leukemia in Remission","Chronic Myelomonocytic Leukemia","Myelodysplastic Syndrome With Excess Blasts","Recurrent Acute Lymphoblastic Leukemia","Recurrent Acute Myeloid Leukemia","Refractory Acute Lymphoblastic Leukemia","Refractory Acute Myeloid Leukemia","Recurrent Mixed Phenotype Acute Leukemia","Refractory Mixed Phenotype Acute Leukemia","Hematopoietic and Lymphoid Cell Neoplasm",[41,42,43],"Lymphoid Leukemia","Myeloid and Monocytic Leukemia","Other Hematopoietic","RECRUITING","2026-06-17",{"date":47,"type":48},"2026-06-22","ACTUAL",{"date":50,"type":48},"2019-07-10",{"date":52,"type":21},"2029-10-20",{"name":54,"class":55},"Fred Hutchinson Cancer Center","OTHER",1,{"id":58,"slug":59,"hasResults":11,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":4,"eligibilityCriteria":63,"healthyVolunteers":11,"sex":16,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":4,"studyType":22,"phases":68,"briefSummary":70,"conditions":71,"keywords":4,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":56},"100500332","mcw-alphabeta-t-cell-and-b-cell-depletion-with-targeted-atg-dosing-100500332","NCT05794880","MCW Alpha\u002FBeta T-Cell and B-Cell Depletion With Targeted ATG Dosing","Matched Unrelated Donor and Partially Matched Related Donor Peripheral Stem Cell Transplantation With Alpha\u002FBeta T-Cell and B-Cell Depletion for Patients With Hematologic Malignancies With Targeted ATG Dosing Pilot Study, IDE 13641","Inclusion Criteria:\n\n1. Patient age \\\u003C 25 years. Both genders and all races eligible.\n2. Disease eligibility\n\n   * Acute myeloid leukemia, primary or secondary - Disease status: MRD negative (flow MRD ≤ 0.1%)\n   * Myelodysplasia\n   * Acute lymphoblastic leukemia - Disease status: MRD negative\n   * Chronic myelogenous leukemia - Disease status: chronic phase, accelerated phase or blast crisis now in second chronic phase\n   * Mixed lineage or biphenotypic acute leukemia- Disease status: MRD negative\n   * Lymphoblastic lymphoma - Disease status: in remission\n   * Burkitt's lymphoma\u002Fleukemia - Disease status: in remission\n   * Lymphoma after relapse - Disease status: in remission\n   * Other malignant hematologic diseases in remission (to be approved by PI)\n3. Karnofsky Performance Status ≥ 60% for patients 16 years and older and Lansky Play Score ≥ 60 for patients under 16 years of age (Appendix 1)\n4. Evaluation of organ status as per MCW BMT SOP\n5. Infectious disease criteria: No active untreated infection. Patients with possible fungal infections must have had at least 2 weeks of appropriate anti-fungal antibiotics and be asymptomatic.\n6. Signed consent by parent\u002Fguardian or able to give consent if ≥18 years.\n7. Negative pregnancy test for patients capable of childbearing potential\n8. Sexually active patients capable of child-bearing potential must agree to use adequate contraception (diaphragm, birth control pills, injections, intrauterine device \\[IUD\\], surgical sterilization, subcutaneous implants, or abstinence, etc.) for the duration of treatment. Sexually active men must agree to use barrier contraceptive for the duration of treatment.\n\nDonor Eligibility:\n\n1. Unrelated donor meets National Marrow Donor Program criteria for donation\n2. Infectious disease testing\n3. MCW BMT procedures apply for determining donor eligibility, including donor screening and testing for relevant communicable disease agents and diseases.\n4. Only Peripheral blood stem cells will be used for stem cell source on this study therefore donor must be willing to undergo G-CSF mobilization and stem cell apheresis. Donor matching. High resolution typing at all loci to be performed.\n5. Unrelated Donor:\n\n   a. HLA typing of at least 10 alleles is required. Donor must be matched at 9\u002F10 or 10\u002F10 alleles (HLA A, B, C, DRB1, DQB1).Donor and collection center willing to undergo mobilization and apheresis\n6. Haploidentical Related Donor:\n\n   1. Haploidentical parent or other related donor: Minimum match level full haploidentical (at least 5\u002F10; HLA A, B, C, DRB1, DQB1 alleles), but use of haploidentical donors with extra matches (e.g. 6, 7, or 8\u002F10) encouraged.\n\nExclusion Criteria:\n\n1. Patients who do not meet disease, organ, or infectious criteria.\n2. No suitable donor\n3. Pregnant or lactating patients are ineligible as many of the medications used in this protocol could be harmful to unborn children and infants\n4. Receiving concomitant chemotherapy, radiation therapy; immunotherapy or other anti-cancer therapy for treatment of disease other than is specified in the protocol. Maintenance or other post-HCT therapy can be considered after discussion with the study PI.\n5. Participating in a concomitant Phase 1 or 2 study involving treatment of disease\n6. Active malignancy other than eligible disease specified in the protocol. Patients with prior malignancy can be eligible as long as at least 1 year post treatment for that malignancy.","0 Years","25 Years",{"count":67,"type":21},40,[69],"NA","This is a single arm pilot study for patients with hematologic malignancies receiving unrelated or haploidentical related mobilized peripheral stem cells (PSCs) using the CliniMACS system for alpha\u002Fbeta T cell depletion plus CD19+ B cell depletion with individualized ALC-based dosing of ATG to study impact on engraftment, GVHD, and disease free survival",[72,30,73,28,74,75,76,77,78,79,80,81,82],"Leukemia","Myelodysplasia","Chronic Myelogenous Leukemia - Chronic Phase","Chronic Myelogenous Leukemia, Accelerated Phase","Chronic Myelogenous Leukemia With Crisis of Blast Cells","Biphenotypic Acute Leukemia","Lymphoblastic Lymphoma","Burkitt Lymphoma","Burkitt Leukemia","Lymphoma After Relapse","Other Malignant Hematologic Diseases in Remission","2026-05-08",{"date":85,"type":48},"2026-05-13",{"date":87,"type":48},"2023-05-01",{"date":89,"type":21},"2032-05",{"name":91,"class":55},"Medical College of Wisconsin",{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":4,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":99,"targetDuration":4,"studyType":22,"phases":101,"briefSummary":102,"conditions":103,"keywords":107,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":119},"100549905","phase-1-ziftomenib-maintenance-post-allo-hct-100549905","NCT06440135","Ziftomenib Maintenance Post Allo-HCT","An Open Label Phase I Study of Ziftomenib as Maintenance Therapy Following Allogeneic Hematopoietic Cell Transplantation","Inclusion Criteria:\n\n* 18 years or older.\n* Pathologically confirmed diagnosis of acute myeloid leukemia (AML).\n* Complete remission (CR) or complete remission with incomplete count recovery (CRi) at screening.\n\n  * Complete remission (CR):\n\n    * no circulating blasts in peripheral blood and \\\u003C5% blasts in bone marrow\n    * no extramedullary disease\n    * platelet count ≥100 x 10(9)\u002FL and\u002For absolute neutrophil count ≥1000\u002FµL\n  * Complete remission with incomplete count recovery (CRi):\n\n    * no circulating blasts in peripheral blood and \\\u003C5% blasts in bone marrow\n    * no extramedullary disease\n    * platelet count \\\u003C100 x 10(9)\u002FL and\u002For absolute neutrophil count \\\u003C1000\u002FµL\n* Presence of at least one of the following molecular mutations:\n\n  * KMT2A rearrangement\n\n    * Eligibility and enrollment will be based on local mutational testing.\n    * The presence of a KMT2A rearrangement (excluding partial tandem duplication \\[PTD\\]) at the time of initial diagnosis or any other time thereafter is sufficient.\n    * Participants may receive additional treatment for AML between consent and transplant.\n  * NPM1 mutation\n\n    * Eligibility and enrollment will be based on local mutational testing.\n    * For participants being transplanted in CR1, the presence of a NPM1 mutation at screening is necessary for the purposes of eligibility.\n    * For participants being transplanted in greater than or equal to CR2, the presence of a NPM1 mutation at the time of consent is not necessary for eligibility and its presence at the time of initial diagnosis or any other time thereafter is sufficient.\n    * Participants may receive additional treatment for AML between consent and transplant.\n* Treatment with a menin inhibitor prior to transplant is permitted. However, patients who experienced AML relapse or progression while being treated with a menin inhibitor prior to transplant are ineligible.\n* Will undergo first allogeneic HCT for their malignancy.\n* Transplantation will be performed with the use of conventional myeloablative (MAC) or reduced intensity conditioning (RIC).\n* HCT Donor will be one of the following:\n\n  * 5\u002F6 or 6\u002F6 (HLA-A, B, DR) matched related donor\n  * 7\u002F8 or 8\u002F8 (HLA-A, B, DR, C) matched unrelated donor. Matching in the unrelated setting must be at the allele level.\n  * Haploidentical related donor, defined as ≥ 3\u002F6 (HLA-A, B, DR) matched\n  * ≥ 4\u002F6 (HLA-A, B, DR) umbilical cord blood (UCB). Matching in the UCB setting is at the antigen level. Recipients may receive either one or two UCB units. In the case of 2 UCB units, both units must have been at least 4\u002F6 matched with the recipient.\n* Any non-investigational GVHD prophylaxis regimen is allowed.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.\n* Participants must have normal organ and function as defined below:\n\n  * AST (SGOT), ALT (SGPT) and Alkaline phosphatase \\\u003C 3x institutional upper limit of normal (ULN)\n  * Total bilirubin \\\u003C 1.5 x institutional ULN (with the exception of subjects with a history of Gilbert's syndrome, for which the total bilirubin must be \\\u003C 5 x ULN)\n  * Calculated creatinine clearance ≥ 30 mL\u002Fmin (Cockcroft-Gault formula)\n* LVEF must be ≥50%, as measured by MUGA scan or echocardiogram.\n* Female patients of childbearing potential must have a negative pregnancy test, as measured by serum or urine testing.\n* The effects of ziftomenib on the developing human fetus are unknown. For this reason women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) during the entire study treatment period and through 6 months after the last dose of treatment.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* History of other malignancy(ies) unless\n\n  * the participant has been disease-free for at least 2 years and is deemed by the investigator to be at low risk of recurrence of that malignancy, or\n  * the cancer has been deemed indolent with no progression over the last 2 years, and deemed by the investigator to be at low risk for further progression during the course of study and follow-up\n  * the only prior malignancy was cervical cancer in situ and\u002For basal cell or squamous cell carcinoma of the skin\n* Known diagnosis of active hepatitis B or hepatitis C\n* Current or history of congestive heart failure New York Heart Association (NHYA) class 3 or 4, or any history of documented diastolic or systolic dysfunction (LVEF \\\u003C 50%, as measured by multigated acquisition (MUGA) scan or echocardiogram)\n* Current or history of ventricular or life-threatening arrhythmias or diagnosis of long-QT syndrome\n* Systemic uncontrolled infection\n* Known dysphagia, short-gut syndrome, gastroparesis, or other condition(s) that limits the ingestion or gastrointestinal absorption of drugs administered orally\n* Uncontrolled hypertension (systolic blood pressure \\[BP\\] \\> 180 mmHg or diastolic BP \\> 100 mmHg)\n* QTc interval (i.e., Friderica's correction \\[QTcF\\]) ≥ 480 ms or other factors that increase the risk of QT prolongation or arrhythmic events (e.g., heart failure, hypokalemia, family history of long QT interval syndrome) at screening\n* Uncontrolled intercurrent illness that would limit compliance with study requirements.\n* Persons who are pregnant or lactating.",{"count":100,"type":21},22,[24],"The purpose of this study is to test the safety, effects, and recommended dose of an investigational drug, ziftomenib, in addition to the standard treatment on blood cancer with Allogeneic Hematopoietic Cell Transplantation (allo-HCT). This study plans to learn more about ziftomenib, which targets and inhibits negative interactions within cancer cells related to AML, when given after allo-HCT, to determine if it improves outcomes following allo-HCT.\n\nThe name of the study drug involved in this study is:\n\n• Ziftomenib",[104,30,105,106],"Acute Myeloid Leukemia","NPM1 Mutation","KMT2A Rearrangement",[104,108,109,105,106],"Allogeneic hematopoietic cell transplantation (HCT)","Allo-HCT","2026-03-17",{"date":112,"type":48},"2026-03-19",{"date":114,"type":48},"2024-06-11",{"date":116,"type":21},"2027-09-01",{"name":118,"class":55},"Massachusetts General Hospital",2,{"id":121,"slug":122,"hasResults":11,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":126,"eligibilityCriteria":127,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":128,"enrollmentInfo":129,"targetDuration":4,"studyType":22,"phases":131,"briefSummary":132,"conditions":133,"keywords":134,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":148},"100509743","phase-2-study-comparing-the-efficacy-of-2-ric-regimens-clofarabine-vs-fludarabine-in-adults-with-aml-eligible-to-allo-sct-100509743","NCT05917405","Study Comparing the Efficacy of 2 RIC Regimens (Clofarabine vs Fludarabine) in Adults With AML Eligible to Allo-SCT","FLUCLORIC: Randomized Multicentric Phase III Study Comparing the Efficacy of 2 Reduced Intensity Conditioning Regimens (Clofarabine\u002FBusulfan vs Fludarabine\u002FBusulfan) in Adults With AML and Eligible to Allogeneic Stem Cell Transplantation","FLUCLORIC","Inclusion Criteria:\n\nAge ≥ 18 years' old\n\n* De novo or secondary AML (according to ELN 2022 classification) in complete cytological remission at time of transplant (bone marrow blast count \\\u003C 5%) or MDS\u002FLAM with bone marrow blast count ≤ 5%\n* Patients in first or second line therapy are allowed\n* Patient eligible to a RIC regimen : patients aged ≥ 60 year old or \\\u003C60 with co-morbidity(ies).\n* Patient with a related or an unrelated matched donor\n* Graft using only peripheral blood stem cells\n* Performance status ECOG 0 - 2\n* Who provide their written informed consent\n* Previous allograft allowed\n* Affiliated with French social security system or beneficiary from such system\n* Women must meet one of the following criteria at the time of inclusion:\n\n  * use adequate contraceptive measures as recommended by the CTFG (Recommendations related to contraception and pregnancy testing in clinical trials v1.1; includes injectable implants, dual hormone birth control pills, intrauterine devices, abstinence from sex, or a sterilized partner), and have a negative pregnancy test (urine or serum pregnancy test) prior to receiving the first dose of study drug;\n  * or be post-menopausal (over 50 years of age with amenorrhea for at least 12 months after discontinuation of all exogenous hormonal therapy)\n  * or (if under 50 years of age) have been amenorrheic for at least 12 months after discontinuation of exogenous hormonal therapy and with luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels corresponding to post-menopausal levels\n  * or have undergone irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy (this operation must be documented).\n  * Contraception methods must be prescribed using effective contraceptive methods during treatment and within 6 months for women of childbearing age (WOCB) and 6 months for men in case they have sexual relations with WOCB after the last dose of Fludarabine\u002FClofarabine.\n\nExclusion Criteria:\n\n* Pro-myelocytic leukemia\n* Patient eligible to a myeloablative conditioning regimen\n* Patient with haploidentical, mismatched unrelated donor or umbilical cord blood\n* Pregnant or breastfeeding woman or patient refusing contraceptive mesures\n* HIV positive\n* Active Hepatitis B or C\n* Left ventricular ejection fraction \\\u003C 50%.\n* DLCOc \\\u003C40%\n* Uncontrolled infection\n* Uncontrolled haemolytic anaemia\n* Creatinine clearance \\\u003C 50 ml\u002Fmin (evaluated by MDRD or CKDEPI).\n* Serum bilirubine \\> 30 mmol\u002Fl, Cytolysis \\> 5 the upper limit range\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 2 years\n* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule\n* Participation to another interventional study during the last month or expected participation to another interventional study during participation to the FLUCLORIC study.","99 Years",{"count":130,"type":21},302,[25],"Relapse remains the main cause of death in patients with myeloid malignancies, especially after an allotransplant. Using drugs with higher anti-leukemic activity as part of the conditioning regimen is one of the strategies to decrease relapse incidence in this population. Retrospective studies have shown that clofarabine can achieve impressive results compared to the use of fludarabine in acute myeloid leukemia (AML) as part of the conditioning regimen. Confirming such results in a prospective manner would definitely establish the CloB2A2 as a superior reduced-intensity conditioning (RIC) regimen compared to the FB2A2 for AML patients.302 AML patients (151 in each arm) in complete remission at transplant will be included with the main objective to demonstrate a significant better 2-year overall survival for CloB2A2 cases (70% vs 55%). A cost-utility analysis and a cost-effectiveness analysis will be also performed as well as an assessment of the quality of life after transplant. Clofarabine will be furnished to all centers. The duration of the study will be 5 years with 3 years of inclusion and 2 years of follow-up for each patient.",[30],[104,135,136,137,138],"Clofarabine","fludarabine","reduced intensity conditioning regimen","allogeneic stem cells transplantation","2026-01-28",{"date":141,"type":48},"2026-01-30",{"date":143,"type":48},"2023-09-14",{"date":145,"type":21},"2028-09-14",{"name":147,"class":55},"Nantes University Hospital",23,{"id":150,"slug":151,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":4,"eligibilityCriteria":155,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":156,"targetDuration":4,"studyType":22,"phases":158,"briefSummary":153,"conditions":159,"keywords":160,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":56},"100605536","phase-2-pilot-study-of-reduced-venetoclax-exposure-100605536","NCT07163793","Pilot Study of Reduced Venetoclax Exposure","A Pilot Study of Reduced Venetoclax Exposure in Patients With Acute Myeloid Leukemia in Complete Remission","Inclusion Criteria:\n\n1. Stated willingness to comply with all study procedures and availability for the duration of the study\n2. Ability to take oral medication and be willing to adhere to the study regimen\n3. Diagnosed by current WHO or ICC criteria with Acute Myeloid Leukemia and treated for initial induction therapy with one of two regimens:\n\n   1. 5-Azacitidine administered subcutaneously at a dose of 75mg\u002Fm2\u002Fday X 7 days in combination with VEN (21-28 days\u002Fcycle)\n   2. Decitabine administered intravenously at a dose of 20mg\u002Fm2\u002Fday administered in combination with VEN (21-28 days\u002Fcycle)\n4. Achieving morphological CR\u002FCRi by bone marrow biopsy with \\\u003C5% blasts within 3 cycles. See Appendix 2 for definitions.\n5. Consent to be obtained within 10 days (+\u002F- 3 days) of bone marrow biopsy report showing morphological remission. C1D1 of trial to be initiated within 10 days (+\u002F- 7 days) of bone marrow biopsy report showing morphological remission.\n6. ECOG 0-3\n7. Intensive treatment ineligible; transplant ineligible or refusal of transplant\n8. Patient must be able to understand and sign informed consent and additional study documents\n9. On C1D1 of trial, patient must have count recovery with ANC \\>1000, platelets \\> 50, Hemoglobin \\> 7.7 and without transfusion support for 7 days.\n10. No growth factor (G-CSF) use in 14 days prior to C1 D1 of trial.\n\nExclusion Criteria:\n\n1. Treatment with another investigational drug\n2. Use of growth factor (G-CSF) within the last 14 days prior to C1D1 of trial treatment.\n3. On concomitant targeted therapy such as FLT3 inhibitor or IDH1\u002F2 inhibitor.\n4. Subject has received treatment prior to induction with the following:\n\n   i. Prior hypomethylating agent or BCL-2 inhibitor for either AML or MDS other than for induction prior to enrollment.\n\n   ii. Prior CAR-T cell therapy. iii. Experimental or investigational drug therapy for 14 days prior to study entry leukemia-directed therapies.\n5. Subject has:\n\n   i. Acute promyelocytic leukemia (APL) with t(15;17). ii. Presence of t(9;22) given the potential indication for concurrent tyrosine kinase therapy.\n\n   iii. Known active CNS involvement with AML.",{"count":157,"type":21},41,[25],[30],[161],"AML","2025-11-19",{"date":164,"type":48},"2025-11-20",{"date":166,"type":48},"2024-10-07",{"date":168,"type":21},"2028-10",{"name":170,"class":55},"Northwell Health",{"id":172,"slug":173,"hasResults":11,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":4,"eligibilityCriteria":177,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":178,"targetDuration":4,"studyType":22,"phases":180,"briefSummary":181,"conditions":182,"keywords":193,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":215},"100551613","phase-1-prevention-of-gvhd-in-participants-with-hematological-malignancies-undergoing-hematopoietic-stem-cell-transplant-hsct-100551613","NCT06462365","Prevention of GvHD in Participants With Hematological Malignancies Undergoing Hematopoietic Stem Cell Transplant (HSCT)","Phase I, First in Human, Open Label Study to Evaluate Safety and Tolerability of TRX103 Cells in Subjects With Hematological Malignancies Undergoing HLA-mismatched Related or Unrelated Hematopoietic Stem Cell Transplantation (HSCT)","Inclusion Criteria:\n\n1. Subjects with one of the following hematologic malignancies: Acute Lymphoblastic Leukemia (B- or T-ALL), Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS), or Chronic myelomonocytic leukemia (CMML)\n2. Males and Females Age ≥ 18 years.\n3. Weight of ≥ 35 Kg.\n4. Karnofsky performance status ≥ 70 %.\n5. Available mismatched related (haploidentical) or unrelated donors for peripheral blood stem cell (PBSC) donation.\n6. Subjects must otherwise fulfill institutional criteria for eligibility to undergo allogeneic stem cell transplantation.\n7. Absence of uncontrolled bacterial, viral or fungal infection at time of enrollment.\n8. Have adequate organ function.\n9. Subjects \\> 65-year-old receiving MAC conditioning will only be eligible if they have a HSCT-comorbidity index score \\\u003C 5.\n10. Subjects must be able to understand and sign informed consent and be willing and able to complete all specified procedures and visits.\n\nExclusion Criteria:\n\n1. Prior allogeneic bone marrow, peripheral blood, or cord blood HSCT.\n2. Any subject with a history of significant renal, hepatic, pulmonary, or cardiac dysfunction, or on treatment to support cardiac dysfunction.\n3. HIV positive.\n4. Positive hepatitis-B surface antigen. Subject may be included if they are HBV PCR negative.\n5. Positive hepatitis-C antibody with positive Recombinant Immunoblot Assay (RIBA) or PCR unless the subject has received curative anti-viral treatment and confirmed negative viral load by PCR.\n6. Received another investigational agent for treatment of disease understudy within 28 days (or 5 half-lives, whichever is shorter) of conditioning and\u002For have not recovered from treatment related toxicities.\n7. Subjects with a previous history of Thrombotic Thrombocytopenic Purpura (TTP) or Hemolytic Uremic Syndrome (HUS) who are not good candidates for treatment with sirolimus.\n8. Subjects that are pregnant, breast feeding or aim to become pregnant during the study period. (Subjects must agree to use a highly effective method of contraception).\n9. Any serious illness, uncontrolled inter-current illness, psychiatric illness, active or uncontrolled infection, or other medical condition or history, including laboratory results.",{"count":179,"type":21},36,[24],"The purpose of this Phase 1, first in human open-label study is to assess the safety and tolerability of TRX-103 in patients with hematological malignancies undergoing HLA-mismatched related or unrelated hematopoietic stem cell transplantation (HSCT). It is anticipated that up to 36 Subjects will be enrolled during a 18-24 month enrollment period. TRX-103 will be infused one time post HSCT.",[183,184,185,186,187,188,189,30,190,191,192],"Hematologic Malignancy","GvHD","GVHD,Acute","GVHD, Chronic","Hematopoietic Stem Cell Transplant","Acute Lymphoblastic Leukemia, Adult B-Cell","Acute Lymphoblastic Leukemia, Adult T-Cell","Myelodysplastic Syndromes","Chronic Myelomonocytic Leukemia, in Remission","Cancer Remission",[161,194,195,196,197,198,199,200,201,202,203,204],"CMML","Stem Cell Transplant","B-ALL","T-ALL","Acute GvHD","Graft versus Host Disease","Chronic GvHD","MDS","Cellular Therapy","Autoimmune","T regulatory cells","2025-04-10",{"date":207,"type":48},"2025-04-15",{"date":209,"type":48},"2024-04-08",{"date":211,"type":21},"2027-04-15",{"name":213,"class":214},"Tr1X, Inc.","INDUSTRY",5,{"id":217,"slug":218,"hasResults":11,"nctId":219,"briefTitle":220,"officialTitle":221,"acronym":222,"eligibilityCriteria":223,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":224,"targetDuration":4,"studyType":22,"phases":226,"briefSummary":227,"conditions":228,"keywords":237,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":250,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":256,"locationsCount":258},"100351175","phase-2-allogeneic-hematopoietic-cell-transplantation-from-hla-matched-donor-after-flu-mel-ptcy-versus-flu-mel-atg-reduced-intensity-conditioning-100351175","NCT03852407","Allogeneic Hematopoietic Cell Transplantation From HLA-matched Donor After Flu-Mel-PTCy Versus Flu-Mel-ATG Reduced-intensity Conditioning","Allogeneic Hematopoietic Cell Transplantation From HLA-matched Donor After Flu-Mel-PTCy Versus Flu-Mel-ATG Reduced-intensity Conditioning: a Phase II Randomized Study From the Belgian Hematology Society (BHS)","HLA","Inclusion Criteria:\n\nPatients V.1.1. Diseases\n\nHematological malignancies confirmed histologically:\n\n* AML in morphological CR or not in morphological CR but not rapidly progressing (i.e. no need to give treatments such as hydroxyurea to maintain WBC count \\\u003C 10 000 x109\u002FmL);\n* MDS;\n* CML in CP or AP;\n* MPD not in blast crisis,\n* MDS\u002FMPD overlap,\n* ALL in CR;\n* Multiple myeloma;\n* CLL;\n* Non-Hodgkin's lymphoma (aggressive NHL should have chemosensitive disease);\n* Hodgkin's disease with chemosensitive disease or responding to checkpoint inhibitors.\n\n  \\* Clinical situations\n\n  • Theoretical indication for a standard allo-transplant, but not feasible because:\n* Age \\> 50 yrs;\n* Unacceptable end organ performance;\n* The physician's decision;\n* The patient's decision\n\n  * Underlying 'lower risk' disease, for which Reduced Intensity Conditioning is preferred (eg CLL, MCL)\n\n    \\* Other inclusion criteria\n  * Male or female; fertile patients must use a reliable contraception method;\n  * Age 18-75 yrs (children of any age are not allowed in the protocol);\n  * Informed consent given by patient or his\u002Fher guardian if indicated.\n\nDonors\n\n* Male or female;\n* Any age;\n* Human Leukocyte Antigen (HLA)-identical sibling donor or 10 of 10 (HLA-A, -B, -C, -DRB1, and -DQB1) HLA allele matched unrelated donor;\n* Weight \\> 15 Kg (because of leukapheresis);\n* Fulfills criteria for allogeneic Peripheral Blood Stem Cell (PBSC) donation according to standard procedures;\n* Informed consent given by donor or his\u002Fher guardian if indicated, as per donor center standard procedures.\n\nExclusion Criteria:\n\nPatients\n\n* Any condition not fulfilling inclusion criteria;\n* Human Immunodeficiency Virus positive;\n* Non-hematological malignancy(ies) (except non-melanoma skin cancer) active \\\u003C 3 years before Hematopoietic Cell Transplantation (HCT).\n* Life expectancy severely limited by disease other than malignancy;\n* Central Nervous System involvement with disease refractory to intrathecal chemotherapy.\n* Terminal organ failure, except for renal failure (dialysis acceptable)\n\n  1. Cardiac: Symptomatic coronary artery disease; ejection fraction \\\u003C40%; uncontrolled arrhythmia, uncontrolled hypertension;\n  2. Pulmonary: Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)\\\u003C 40% and\u002For receiving supplementary continuous oxygen, Forced Expiratory Volume in 1 Second (FEV1)\\\u003C 40%;\n  3. Hepatic: Fulminant liver failure, cirrhosis of the liver with evidence of portal hypertension, alcoholic hepatitis, esophageal varices, a history of bleeding esophageal varices, hepatic encephalopathy, uncorrectable hepatic synthetic dysfunction evinced by prolongation of the prothrombin time, ascites related to portal hypertension, bacterial or fungal liver abscess, biliary obstruction, chronic viral hepatitis with total serum bilirubin \\>3 mg\u002FdL, and symptomatic biliary disease;\n* Uncontrolled infection;\n* Karnofsky Performance Score \\\u003C70%;\n* Patient is a fertile man or woman who is unwilling to use contraceptive techniques during and for 12 months following treatment;\n* Patient is a female who is pregnant or breastfeeding;\n* Any condition precluding the use of melphalan or Thymoglobulin;\n\nDonors\n\n* Any condition not fulfilling inclusion criteria;\n* Unable to undergo leukapheresis because of poor vein access or other reasons.",{"count":225,"type":21},114,[25],"The present project aims at comparing two conditioning regimens (FM-PTCy vs FM-ATG). The hypothesis is that one or the two regimens will lead to a 2-year cGRFS rate improvement from 30% (the cGRFS rate with FM without ATG\u002FPTCy) to 45% (Pick-a-winner phase 2 randomized study).",[30,190,229,230,231,232,233,234,235,236],"Chronic Myeloid Leukemia in Remission","Myeloproliferative Syndrome","Myeloproliferative Disorder","Acute Lymphoid Leukemia in Remission","Multiple Myeloma","Chronic Lymphoid Leukemia","Non Hodgkin Lymphoma","Hodgkin Lymphoma",[238,239,240,241,242,243,244,245,246,247,248],"hematological malignancies","Graft versus host disease","GVHD","Progression free survival","Allogeneic hematopoeitic cell transplantation","HLA-matched donor","reduced intensity conditioning","Overall survival","ATG PK","Immunosuppressive regimen","Prophylaxis","2022-10-11",{"date":251,"type":48},"2022-10-12",{"date":253,"type":48},"2019-02-04",{"date":255,"type":21},"2038-11-01",{"name":257,"class":55},"University of Liege",10]