[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"myelodysplastic-syndromes-mds\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:myelodysplastic-syndromes-mds":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,15,0,[8,47,82,106,129,157,181,224,251,282,316,352,379,401,420],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100367421","phase-3-a-study-to-evaluate-long-term-safety-in-participants-who-have-participated-in-other-luspatercept-ace-536-clinical-trials-100367421",false,"NCT04064060","A Study to Evaluate Long-term Safety in Participants Who Have Participated in Other Luspatercept (ACE-536) Clinical Trials","A Phase 3b, Open-label, Single-arm, Rollover Study to Evaluate Long-term Safety in Subjects Who Have Participated in Other Luspatercept (ACE-536) Clinical Trials","Inclusion Criteria:\n\nParticipants must meet all the following criteria to be enrolled in this study:\n\n1. Participant is ≥ 18 years at the time of signing the informed consent form (ICF).\n2. Participant is willing and able to adhere to the study visit schedule and other protocol requirements.\n3. Participant has been participating in a luspatercept trial and continues to fulfill all the requirements of the parent protocol and the participant has been either:\n\n   1. Assigned to luspatercept treatment, continues to receive clinical benefit in the opinion of the investigator and should continue to receive luspatercept treatment, OR\n   2. Assigned to placebo arm in the parent protocol (at the time of unblinding or in follow-up) and should cross over to luspatercept treatment, OR\n   3. Assigned to the Follow-up Phase of the parent protocol, previously treated with luspatercept or placebo in the parent protocol who shall continue into LTPTFU phase in the rollover study until the follow-up commitments are met (unless requirements are met as per parent protocol to crossover to luspatercept treatment).\n4. Participant understands and voluntarily signs an informed consent document prior to any study-related assessments or procedures being conducted.\n5. Participant demonstrates compliance, as assessed by the investigator, with the parent study protocol requirements.\n6. Applies to on treatment Participants only- females of childbearing potential (FCBP) defined as a sexually mature woman who:\n\n1\\) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy, or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy or amenorrhea due to other medical reasons does not rule out childbearing potential) for at least 24 consecutive months (ie, has had menses at any time in the preceding 24 consecutive months) must:\n\n1. Have two negative pregnancy tests as verified by the investigator prior to starting study therapy. She must agree to ongoing pregnancy testing during the course of the study, and after end of study therapy. This applies even if the participant practices true abstinence from heterosexual contact.\n2. Agrees to use, and be able to comply with highly effective, contraception without interruption, 35 days prior to starting investigational product (IP), during the study therapy (including dose interruptions), and for 84 days after discontinuation of study therapy.\n\n   7\\. Applies to on treatment participants only- Male participants must:\n\na. Agrees to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 84 days following investigational product discontinuation even if he has undergone a successful vasectomy.\n\nExclusion Criteria:\n\nThe presence of any of the following will exclude a participant from enrollment:\n\n1. Applies to on treatment participants only- Concomitant use of any medications\u002Fprocedures that are prohibited in the parent luspatercept protocol.\n2. Participant has met one or more criteria for study discontinuation as stipulated in the parent luspatercept protocol.\n3. Applies to on treatment participants only- More than 26 days between last luspatercept dose in the parent protocol and first dose into ACE-536-LTFU-001 protocol unless dose delay or dose discontinuation criteria met.\n4. Applies to on treatment participants only- Pregnant or breastfeeding females.\n5. Participant has any significant medical condition, laboratory abnormality, psychiatric illness, or is considered vulnerable by local regulations (eg, imprisoned or institutionalized) that would prevent the subject from participating in the study.\n6. Participant has any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he\u002Fshe were to participate in the study.\n7. Participant has any condition that confounds the ability to interpret data from the study.","ALL","18 Years",{"count":19,"type":20},665,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","A Phase 3b, open-label, single-arm, rollover study to evaluate the long-term safety of luspatercept, to the following participants:\n\n* Participants receiving luspatercept on a parent protocol at the time of their transition to the rollover study, who tolerate the protocol-prescribed regimen in the parent trial and, in the opinion of the investigator, may derive clinical benefit from continuing treatment with luspatercept\n* Participants in the follow-up phase previously treated with luspatercept or placebo in the parent protocol will continue into long-term post-treatment follow-up in the rollover study until the follow-up commitments are met\n* The study design is divided into the Transition Phase, Treatment Phase and Follow-up Phase. Participants will enter transition phase and depending on their background will enter either the treatment phase or the Long-term Post-treatment Follow-up (LTPTFU) phase\n* Transition Phase is defined as one Enrollment visit\n* Treatment Phase: For participants in luspatercept treatment the dose and schedule of luspatercept in this study will be the same as the last dose and schedule in the parent luspatercept study. This does not apply to participants that are in long-term follow-up from the parent protocol\n* Follow-up Phase includes:\n\n  \\- 42 Day Safety Follow-up Visit\n* During the Safety Follow up, the participants will be followed for 42 days after the last dose of luspatercept, for the assessment of safety-related parameters and adverse event (AE) reporting\n\n  \\- Long-term Post-treatment Follow-up (LTPTFU) Phase\n* Participants will be followed for overall survival every 6 months for at least 5 years from first dose of luspatercept in the parent protocol, or 3 years of post-treatment from last dose, whichever occurs later, or until death, withdrawal of consent, study termination, or until a subject is lost to follow-up. Participants will also be monitored for progression to AML or any malignancies\u002Fpre-malignancies. New anticancer or disease related therapies should be collected at the same time schedule\n\nParticipants transitioning from a parent luspatercept study in post-treatment follow-up (safety or LTPTFU) will continue from the same equivalent point in this rollover study.\n\nThe ACE-536-LTFU-001 rollover study will be terminated, and relevant participants will discontinue from the study when all participants fulfill 5 years on the study, including treatment and follow-up.",[26,27,28],"Myelodysplastic Syndromes (MDS)","Beta-thalassemia","Myeloproliferative Neoplasm(MPN)-Associated Myelofibrosis",[30,31,32,27,33],"ACE-536","Luspatercept","MDS","Myeloproliferative neoplasm (MPN)-associated myelofibrosis","RECRUITING","2026-06-30",{"date":37,"type":38},"2026-07-01","ACTUAL",{"date":40,"type":38},"2019-08-12",{"date":42,"type":20},"2028-05-12",{"name":44,"class":45},"Celgene","INDUSTRY",143,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":81},"100446362","phase-1-phase-iii-study-of-car70--engineered-il15-transduced-cord-blood-derived-nk-cells-in-conjunction-with-lymphodepleting-chemotherapy-for-the-management-of-relapserefractory-hematological-malignances-100446362","NCT05092451","Phase I\u002FII Study of CAR.70- Engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Chemotherapy for the Management of Relapse\u002FRefractory Hematological Malignances","Inclusion criteria:\n\n1. Patients with hematological malignances with an expression of CD70 in the pre-enrollment tumor sample ≥ 10% measured by immunohistochemistry or flow cytometry.\n2. Patients must meet diseases specific eligibility criteria (see below)\n3. Patients at least 1 week from last cytotoxic chemotherapy at the time of starting lymphodepleting chemotherapy, except for Hydroxyurea which is allowed for peripheral blood count control in AML, CML, and MDS patients until the day prior to administration of lymphodepleting chemotherapy. Patients may continue tyrosine kinase inhibitors or other targeted therapies until up to three days prior to administration of lymphodepleting chemotherapy.\n4. Localized radiotherapy to one or more disease sites is allowed prior the infusion provided that there are additional disease sites that are not irradiated to assess response\n5. Karnofsky Performance Scale \\> 50% for patients who are \\>16 years old or Lansky score ≥50% for patients who are ≤16 years of age.\n6. Adequate organ function:\n\n   1. Renal: Serum creatinine \\\u003C\u002F= 2x ULN or estimated Glomerular Filtration Rate \\>\u002F= 30 ml\u002Fmin\u002F1.73 m2\n   2. Hepatic: ALT\u002FAST \\\u003C\u002F= 3 x ULN or \\\u003C\u002F= 5 x ULN if documented liver metastases, Total bilirubin \\\u003C\u002F2xULN, except in subjects with Gilbert's Syndrome in whom total bilirubin must be \\\u003C\u002F= 3 x.ULN. No history of liver cirrhosis. No ascites.\n   3. Cardiac: Cardiac ejection fraction \\>\u002F= 40%, no clinically significant pericardial effusion as determined by an ECHO, and no uncontrolled arrhythmias or symptomatic cardiac disease.\n   4. Pulmonary: No clinically significant pleural effusion (per PI discretion), baseline oxygen saturation \\> 92% on room air and adequate pulmonary function with FEV1, FVC and DLCO (corrected for Hgb) \\>50%.\n7. Able to provide written informed consent.\n8. 12-80 years of age.\n9. Weight ≥40 kg\n10. All participants who are able to have children must practice effective birth control while on study and up to 3 months post completion of study therapy. Acceptable forms of birth control for female patients include: hormonal birth control, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence, for the length of the study. If the participant is a female and becomes pregnant or suspects pregnancy, she must immediately notify her doctor. If the participant becomes pregnant during this study, she will be taken off this study. Men who are able to have children must use effective birth control while on the study. If the male participant fathers a child or suspects that he has fathered a child while on the study, he must immediately notify his doctor.\n11. Signed consent to long-term follow-up protocol PA17-0483 to fulfill the institutional responsibilities to various regulatory agencies.\n12. Are willing and able to provide informed consent, as appropriate (either directly or through a legally authorized representative \\[LAR\\])\n\nExclusion criteria:\n\n1. Positive beta HCG in female of child-bearing potential defined as not postmenopausal for 24 months or no previous surgical sterilization or lactating females.\n2. Presence of clinically significant Grade 3 or greater toxicity from the previous treatment, as determined by PI.\n3. Presence of uncontrolled fungal, bacterial, viral, or other infection not responding to appropriate therapy.\n4. HIV with detectable viral load\n5. Presence of active neurological disorder(s).\n6. Active autoimmune disease within 12 months of enrollment\n7. Amyloidosis or POEMS syndrome\n8. Active cerebral or meningeal involvement by the malignancy\n9. Active (defined as requiring therapy) acute or chronic GVHD\n10. Any other malignancy known to be active, except for treated cervical intra-epithelial neoplasia and non-melanoma skin cancer.\n11. Presence of any other serious medical condition that may endanger the patient at investigator discretion.\n12. Major surgery \\\u003C4 weeks prior to first dose of the preparatory chemotherapy\n13. Allogeneic SCT or DLI \\\u003C12 weeks prior to first dose of preparatory chemotherapy\n14. Concomitant use of other investigational agents.\n15. Concomitant use of other anti-cancer agents.\n16. Patients receiving systemic steroid therapy at time of NK cell infusion (physiological substitutive doses are allowed), or have received antithymocyte globulin or lymphocyte immune globulin within 14 days of enrollment or alemtuzumab within 28 days of enrollment.\n17. Patients receiving immunosuppressive therapy","12 Years","80 Years",{"count":56,"type":20},80,[58,59],"PHASE1","PHASE2","The goal of this clinical research study is to learn about the safety of giving immune cells called natural killer (NK) cells with chemotherapy to patients with leukemia, lymphoma, or multiple myeloma.\n\nImmune system cells (such as NK cells) are made by the body to attack foreign or cancerous cells. Researchers think that NK cells you receive from a donor may react against cancer cells in your body, which may help to control the disease.",[62,26,63,64,65,66,67,68,69,70],"B-Cell Lymphoma","Acute Myeloid Leukemia (AML)","Multiple Myeloma","Plasma Cell Leukemia","Hodgkin Lymphoma","T-cell Non-Hodgkin's Lymphoma\u002F T-cell Acute Lymphoblastic Leukmeia","Myelodysplastic Syndrome \u002F Chronic Myelomonocytic Leukemia","Blastic Transformation of Chronic Myeloid Leukemia","Germ Cell Tumors","2026-06-04",{"date":73,"type":38},"2026-06-08",{"date":75,"type":38},"2022-11-01",{"date":77,"type":20},"2026-08-31",{"name":79,"class":80},"M.D. Anderson Cancer Center","OTHER",1,{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":90,"targetDuration":4,"studyType":21,"phases":92,"briefSummary":93,"conditions":94,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":105},"100551889","phase-3-ivosidenib-ivo-monotherapy-and-azacitidine-aza-monotherapy-in-patients-with-hypomethylating-agent-hma-naive-myelodysplastic-syndromes-mds-with-an-idh1-mutation-100551889","NCT06465953","Ivosidenib (IVO) Monotherapy and Azacitidine (AZA) Monotherapy in Patients With Hypomethylating Agent (HMA) Naive Myelodysplastic Syndromes (MDS) With an IDH1 Mutation","A Phase 3, Multicenter, Open Label, Randomized, Non-comparative Two-arm Study of Ivosidenib (IVO) Monotherapy and Azacitidine (AZA) Monotherapy in Adult Patients With Hypomethylating Agent (HMA) Naive Myelodysplastic Syndromes (MDS) With an Isocitrate Dehydrogenase-1 (IDH1) Mutation (PyramIDH Study)","PyramIDH","Inclusion Criteria:\n\n* Diagnosis of HMA naive IDH1 R132 mutated MDS defined according to WHO criteria (5th edition):\n* Moderate high, high and very high-risk MDS per IPSS-M score will be eligible regardless of blood counts and with blast counts 0-19%.\n* Low and moderate low-risk MDS per IPSS-M score must:\n* Have cytopenias related to MDS, defined as: \\\u003C100 platelets\u002Fmicroliter, or absolute neutrophil count (ANC) \\\u003C1000\u002Fmm3, or hemoglobin \\\u003C10g\u002FdL AND\n* Have a blast count between 5-19% AND\n* Be eligible for HMA therapy (very low risk participants are to be excluded)\n* Locally or centrally confirmed IDH1 R132 C\u002FG\u002FH\u002FL\u002FS mutation\n\nExclusion Criteria:\n\n* Received prior anticancer\u002Fdisease modifying treatment for MDS (including HMA's, cytotoxic chemotherapy, investigational agents, bcl-2 inhibitor based-regimens, hematopoietic stem cell transplant (HSCT), IDH1 inhibitors). For LR-MDS patients, prior treatment with growth factors, luspatercept, lenalidomide, and imetelstat are allowed.\n* \\>20% blasts by morphology or immunohistochemistry on screening bone marrow aspirate\u002Fbiopsy",{"count":91,"type":20},48,[23],"This study will enroll participants with myelodysplastic syndromes (MDS) with an Isocitrate dehydrogenase protein, 1 (IDH1) mutation, who have not received treatment with a hypomethylating agent previously. Participants will be randomized to receive either ivosidenib (IVO) alone or azacitidine (AZA) alone. IVO will be administered daily throughout the 28-day treatment cycle and AZA will be administered for the first 7 days of each 28-day cycle. Study visits will be conducted every week during Cycle 1 (Days 1, 8, 15, and 22), and Day 1 of each cycle thereafter. After the last dose of treatment, participants will attend an safety follow-up visit and participants will be followed to assess overall survival. Study visits may include a bone marrow aspirate, physical exam, echocardiogram (ECHO), electrocardiogram (ECG), blood and urine analysis, and questionnaires.",[95,26],"Hypomethylating Agent (HMA) Naive Myelodysplastic Syndromes (MDS)","2026-05-08",{"date":98,"type":38},"2026-05-11",{"date":100,"type":38},"2024-12-03",{"date":102,"type":20},"2028-12-01",{"name":104,"class":80},"Institut de Recherches Internationales Servier",62,{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":21,"phases":115,"briefSummary":116,"conditions":117,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":128},"100566539","phase-1-icp-248-in-combination-with-azacitidine-for-the-treatment-in-patients-with-myeloid-malignancies-100566539","NCT06656494","ICP-248 in Combination With Azacitidine for the Treatment in Patients With Myeloid Malignancies","A Phase 1 Study of ICP-248 in Combination With Azacitidine for the Treatment in Patients With Myeloid Malignancies.","Inclusion Criteria:\n\nEligible subjects must meet all of the following criteria:\n\n1. Subject must have confirmation of diagnosis of AML (except for acute promyelocytic leukemia \\[APL\\]) or MDS per 2016 World Health Organization (WHO) criteria.\n2. For AML (except for APL) cohort:\n\n   1. Previously treated relapsed\u002Frefractory AML subjects\n   2. Treatment-naïve AML subjects should be: ≥60 years of age OR ≥18 years and \\\u003C60 years will be eligible if the subject has at least one of the following co-morbidities, which make the subject unfit for intensive chemotherapy\n3. For MDS cohort: Adult TN MDS and R\u002FR MDS: revised International Prognostic Scoring System (IPSS-R) score \\> 3 and bone marrow blasts ≥ 5%.\n4. Subject must have a projected life expectancy of at least 12 weeks.\n5. Subject must have adequate renal function as demonstrated by a creatinine clearance ≥ 30 mL\u002Fmin; determined via urine collection for 24-hour creatinine clearance or by the Cockcroft-Gault formula.\n6. Subject must have adequate liver function\n\nExclusion Criteria:\n\n1. R\u002FR AML or R\u002FR MDS with no response or intolerance to post azacitidine or BCL-2i.\n2. Subject has acute promyelocytic leukemia (French-American-British Class M3 AML) .\n3. Subject has known central nervous system (CNS) leukemia.\n4. Suggest patients with active hepatitis B or C virus infection\n5. History of immunodeficiency, including a positive human immunodeficiency virus (HIV) antibody test.\n6. Subjects have another active malignancy within the past 2 years before study entry, except for curatively treated.",{"count":114,"type":20},266,[58],"Evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ICP-248 in combination with azacitidine in patients with acute myelogenous leukemia and Myelodysplastic Syndromes.",[118,26],"Acute Myelogenous Leukemia","2026-04-08",{"date":121,"type":38},"2026-04-13",{"date":123,"type":38},"2024-12-18",{"date":125,"type":20},"2028-01",{"name":127,"class":45},"Beijing InnoCare Pharma Tech Co., Ltd.",18,{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":135,"eligibilityCriteria":136,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":137,"targetDuration":4,"studyType":21,"phases":139,"briefSummary":140,"conditions":141,"keywords":143,"overallStatus":148,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":4},"100632681","phase-2-dapagliflozin-for-anemia-in-lower-risk-myelodysplastic-syndromes-100632681","NCT07516847","Dapagliflozin for Anemia in Lower-Risk Myelodysplastic Syndromes","A Phase II, Prospective, Open-Label Study to Evaluate the Efficacy and Safety of Dapagliflozin for Anemia in Patients With Lower-Risk Myelodysplastic Syndromes","DAPA-MDS1","Inclusion Criteria:\n\n* Adults aged ≥18 years\n* Diagnosis of myelodysplastic syndromes (MDS) according to WHO or ICC criteria\n* Revised International Prognostic Scoring System (IPSS-R) very low, low, or intermediate risk\n* Hemoglobin ≤10 g\u002FdL at screening\n* Transfusion independent or low transfusion burden (Defined as ≤2 units of red blood cell transfusion within 8 weeks prior to enrollment)\n* If receiving erythropoiesis-stimulating agents (ESA) or other anemia-directed therapy, on a stable dose for at least 8 weeks prior to enrollment\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* Absolute neutrophil count (ANC) ≥0.75 ×10⁹\u002FL\n* Platelet count ≥50 ×10⁹\u002FL\n* Adequate organ function:\n\nCreatinine clearance ≥30 mL\u002Fmin AST or ALT ≤3 × upper limit of normal\n\nExclusion Criteria:\n\n* IPSS-R intermediate-high or high-risk MDS\n* Transformation to acute myeloid leukemia or ≥20% blasts\n* Initiation or dose change of MDS- or anemia-directed therapy (e.g., ESA, luspatercept, hypomethylating agents) within 8 weeks prior to screening\n* Red blood cell transfusion \\>2 units within 8 weeks prior to enrollment\n* Current use of SGLT2 inhibitors or history of serious adverse reaction to SGLT2 inhibitors\n* Uncontrolled diabetes mellitus (e.g., HbA1c \\>10%) or history of diabetic ketoacidosis\n* Estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\u002F1.73 m²\n* Active or uncontrolled infection\n* Absolute neutrophil count (ANC) \\\u003C0.75 ×10⁹\u002FL or platelet count \\\u003C50 ×10⁹\u002FL\n* Pregnant or breastfeeding women\n* Any condition that, in the investigator's judgment, would make participation inappropriate",{"count":138,"type":20},37,[59],"This study is a prospective, single-arm, phase II clinical trial designed to evaluate the efficacy and safety of dapagliflozin in improving anemia in patients with lower-risk myelodysplastic syndromes (MDS).\n\nAnemia is the most common clinical problem in patients with lower-risk MDS and often leads to fatigue, reduced quality of life, and the need for repeated blood transfusions. Current treatment options, including erythropoiesis-stimulating agents and other therapies, are not effective in all patients, and additional treatment options are needed.\n\nDapagliflozin is a sodium-glucose cotransporter-2 (SGLT2) inhibitor that is widely used for the treatment of diabetes, heart failure, and chronic kidney disease. Previous studies have shown that SGLT2 inhibitors can increase hemoglobin levels, possibly by stimulating erythropoiesis.\n\nIn this study, eligible patients will receive dapagliflozin 10 mg orally once daily for 24 weeks. The primary objective is to evaluate the hemoglobin response rate during the study period. Secondary objectives include changes in hemoglobin levels, transfusion requirements, and safety outcomes.\n\nThis study aims to explore whether dapagliflozin can serve as a potential treatment option for anemia in patients with lower-risk MDS.",[26,142],"Anemia",[144,142,145,146,147],"Myelodysplastic Syndromes","SGLT2 inhibitor","Dapagliflozin","Lower-risk MDS","NOT_YET_RECRUITING","2026-04-01",{"date":119,"type":38},{"date":152,"type":20},"2026-09",{"date":154,"type":20},"2029-09",{"name":156,"class":80},"Seug yun Yoon, MD",{"id":158,"slug":159,"hasResults":11,"nctId":160,"briefTitle":161,"officialTitle":161,"acronym":4,"eligibilityCriteria":162,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":163,"targetDuration":165,"studyType":166,"phases":4,"briefSummary":167,"conditions":168,"keywords":169,"overallStatus":148,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":180},"100620273","asia-myelodysplastic-syndrome-mds-registry-100620273","NCT07355478","Asia Myelodysplastic Syndrome (MDS) Registry","Inclusion Criteria:\n\nRetrospective enrolment of Myelodysplastic Syndrome (MDS) participants:\n\n* Aged at least 18 years at initial diagnosis of MDS\n* Diagnosed with MDS according to World Health Organization (WHO) 2008, WHO 2016, or WHO 2022 criteria between 1 January 2019 and 31 December 2022; and\n* Diagnosed with MDS within 100 days from the date of diagnostic bone marrow (BM) aspirate\n\nInclusion criteria for the prospective enrolment of MDS participants:\n\n* Aged at least 18 years at initial diagnosis of MDS; and\n* Diagnosed with MDS according to World Health Organization (WHO) 2008, WHO 2016, or WHO 2022 criteria between 1 October 2025 and 30 September 2026; and\n* Diagnosed with MDS within 100 days from the date of diagnostic BM aspirate\n\nExclusion Criteria:\n\n• None",{"count":164,"type":20},500,"2 Years","OBSERVATIONAL","The purpose of this study is to provide a contemporary view and offer invaluable insights into the demographic profiles, clinical characteristics, treatments, and real-world outcomes of individuals with myelodysplastic syndromes (MDS) in Asia.",[26],[170],"Myelodysplastic syndromes (MDS)","2026-02-12",{"date":173,"type":38},"2026-02-13",{"date":175,"type":20},"2026-03-26",{"date":177,"type":20},"2027-09-30",{"name":179,"class":45},"Bristol-Myers Squibb",3,{"id":182,"slug":183,"hasResults":11,"nctId":184,"briefTitle":185,"officialTitle":186,"acronym":187,"eligibilityCriteria":188,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":189,"enrollmentInfo":190,"targetDuration":4,"studyType":21,"phases":191,"briefSummary":193,"conditions":194,"keywords":198,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":216,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":81},"100574945","early-phase-1-cart123-t-cells-in-relapsed-or-refractory-cd123-hematologic-malignancies-a-dose-escalation-phase-i-trial-100574945","NCT06765876","CART123 T Cells in Relapsed or Refractory CD123+ Hematologic Malignancies: A Dose Escalation Phase I Trial","Safety and Efficacy of Anti-CD123 Chimeric Antigen Receptor-Modified Autologous T Cells (CART123) in Patients With Relapsed\u002FRefractory CD123+ Hematologic Malignancies: A Dose Escalation, Open-Label, Phase I Study","UHKT-CAR123-01","Inclusion Criteria:\n\n1. Patients with AML, MDS-IB2, BPDCN or ALL positive for CD123 antigen, who meet one of disease specific criteria below:\n\n   a) Patients with AML will be eligible if they meet one of the following criteria:\n\n   i) Patient with refractory AML defined as failure to achieve CR or CRi after at least 2 cycles of induction chemotherapy or 1 cycle of high dose salvage regimen or 4 cycles of venetoclax with azacytidine OR\n\n   ii) Second or subsequent relapse of AML OR\n\n   iii) Relapse after allogeneic HSCT.\n\n   b) Patients with ALL will be eligible if they meet one of following criteria:\n\n   i) disease refractory to or relapsed after CAR-19 cell therapy OR\n\n   ii) CD19 negative relapse ineligible for treatment with TKI inhibitors and inotuzumab ozogamicin.\n\n   c) Patients with BPDCN will be eligible if they meet following criteria:\n\n   i) Refractory or relapsing after chemotherapy with or without allogeneic stem cell transplantation.\n\n   d) Patients with MDS-IB2 will be eligible if they meet one of following criteria:\n\n   i) Disease refractory to at least four cycles of azacytidine or progression on azacytidine-based therapy OR\n\n   ii) Disease refractory to induction chemotherapy OR\n\n   iii) Relapse after haematopoietic stem cell transplantation.\n2. CD123 expression on malignant cells confirmed by flow cytometry or by immunohistochemistry.\n3. Age between 18 and 70 years.\n4. Patient has a suitable donor for allogeneic hematopoietic stem cell transplantation. Workup and clearance of the donor must be completed before IMP administration.\n5. Patient able to understand and sign informed consent.\n6. Women of child-bearing potential: negative pregnancy test at enrolment (PSV) and at Visit 1.\n7. Patient for whom there are no standard-of-care treatments available or such treatment options have been exhausted.\n\nExclusion Criteria:\n\n1. Known hypersensitivity to any component of the IMP.\n2. Allogeneic HSCT within 3 months prior to IMP administration.\n3. Severe, uncontrolled active infection.\n4. Life expectancy \\\u003C 8 weeks.\n5. Respiratory insufficiency (need for oxygen therapy).\n6. Significant liver impairment: bilirubin \\> 50 µmol\u002FL, AST or ALT \\> 4 times normal upper limit.\n7. Acute kidney injury with serum creatinine \\> 180 µmol\u002FL, oliguria or need for acute dialysis.\n8. Heart failure with LVEF \\\u003C 50% by echocardiography.\n9. Presence of active grade 3 - 4 acute GvHD or severe chronic GvHD.\n10. Serious uncontrolled neurological comorbidity.\n11. Vaccination with live virus vaccines in the 4 weeks before IMP administration and within 90 days after the IMP dose.\n12. Women: pregnancy or breast-feeding.\n13. Subjects of fertile age, unless permanent sexual abstinence is their lifestyle choice:\n\n    1. female patients of childbearing potential not willing to use a highly effective method of contraception during the study,\n    2. male patients whose sexual partner(s) are women of childbearing potential who are not willing to use a highly effective method of contraception during the study.","70 Years",{"count":128,"type":20},[192],"EARLY_PHASE1","Adult patients with refractory or relapsed CD123+ hematologic malignancies, including acute myeloid leukemia, myelodysplastic syndrome, acute lymphoblastic leukemia, or blastic plasmocytoid dentritic cell neoplasm will be recruited in the trial. CART123 cells will be manufatured from blood of each patient. During the production of CAR123 cells, patients may receive appropriate bridging therapy. After cells are produced, participants will undergo a single course of lymphodepleting chemotherapy and receive a single dose of CAR123 T cells. The trial will establish the recommended dose for further studies, either the Maximum Tolerated Dose (MTD) or Maximum Feasible Dose (MFD). Patients must be eligible for hematopoietic stem cell transplantation in order to participate in the trial.",[195,196,26,197],"Leukemia, Myeloid, Acute(AML)","Precursor Cell Lymphoblastic Leukemia-Lymphoma","Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)",[199,200,201,202,203,204,205,206,207,208,209,210,211,212,213,214],"CAR123 T lymphocytes","CART123","CD123+ Hematologic Malignancies","Anti-CD123","Chimeric Antigen Receptor (CAR) T Cells","Autologous T Cells","Hematopoietic Malignancies","Immunotherapy","Personalized Medicine","Biological Therapy","Phase I Clinical Trial","Acute Lymphoblastic Leukemia, in Relapse","Acute Lymphoblastic Leukemia, Refractory","Relapsed Myelodysplastic syndrome","Relapsed Blastic Plasmacytoid Dendritic Cell Neoplasm","Acute Myeloid Leukaemia Recurrent","2026-01-08",{"date":217,"type":38},"2026-01-12",{"date":219,"type":38},"2024-10-23",{"date":221,"type":20},"2028-12-31",{"name":223,"class":80},"Institute of Hematology and Blood Transfusion, Czech Republic",{"id":225,"slug":226,"hasResults":11,"nctId":227,"briefTitle":228,"officialTitle":229,"acronym":4,"eligibilityCriteria":230,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":231,"targetDuration":4,"studyType":21,"phases":233,"briefSummary":235,"conditions":236,"keywords":238,"overallStatus":148,"whyStopped":4,"lastUpdateSubmitDate":242,"lastUpdatePostDateStruct":243,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":249,"locationsCount":4},"100617528","pre-dli-or-pro-dli-in-relapsedrefractory-myeloid-neoplasms-after-hsct-100617528","NCT07319793","Pre-DLI or Pro-DLI in Relapsed\u002FRefractory Myeloid Neoplasms After HSCT","Clinical Study on Optimized Treatment for Allogeneic Hematopoietic Stem Cell Transplantation in Relapsed\u002FRefractory Myeloid Neoplasms","Inclusion Criteria:\n\n* Eligible patients were those who underwent allogeneic hematopoietic stem cell transplantation (allo-HSCT) for myeloid neoplasms (MN), excluding Philadelphia chromosome-positive (Ph+) disease, regardless of age. MN included acute myeloid leukemia (AML) and myelodysplastic syndrome with increased blasts (MDS-IB). Patients were required to have refractory or relapsed disease at the time of transplantation, defined as \\>5% blasts in the bone marrow after salvage chemotherapy and prior to the transplant conditioning regimen. Additionally, patients must have achieved minimal residual disease (MRD)-negative remission within 1 month post-transplantation. All participants provided voluntary written informed consent.\n\nExclusion Criteria:\n\n* Early mortality or relapse within 30 days post-transplantation.\n* Active graft-versus-host disease (GVHD) not under control between 30 and 60 days post-transplantation.\n* Presence of severe or uncontrolled infections.\n* Presence of significant organ dysfunction, defined as:\n\nHepatic dysfunction: Known severe cirrhosis, portal hypertension, or active liver disease; or laboratory-confirmed alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\> 3.0 × the upper limit of normal (ULN) and\u002For total bilirubin (TBIL) \\> 1.5 × ULN.\n\nRenal dysfunction: Estimated glomerular filtration rate (eGFR) \\\u003C 60 mL\u002Fmin\u002F1.73m² (calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation) or serum creatinine \\> 1.5 × ULN; or requirement for regular hemodialysis or peritoneal dialysis.\n\nCardiac dysfunction: New York Heart Association (NYHA) functional class III or IV; unstable angina, acute myocardial infarction, coronary artery bypass grafting (CABG), or percutaneous coronary intervention (PCI) within 6 months prior to enrollment; left ventricular ejection fraction (LVEF) \\\u003C 50% (confirmed by echocardiography or other Doppler examination); clinically significant, uncontrolled arrhythmia.\n\nRespiratory dysfunction: Chronic obstructive pulmonary disease (COPD) or other pulmonary disease requiring long-term oxygen therapy; resting oxygen saturation (SpO₂) \\\u003C 92% on room air.\n\n* Participation in another investigational drug trial within the 3 months prior to enrollment.\n* Any other condition deemed by the investigator to make the patient unsuitable for the study.",{"count":232,"type":20},200,[234],"NA","Donor lymphocyte infusion (DLI) based on minimal residual disease (MRD) has been widely adopted worldwide to enhance the graft-versus-leukemia effect following allogeneic hematopoietic stem cell transplantation (allo-HSCT). However, there is a lack of studies comparing the efficacy and safety of prophylactic versus preemptive DLI in patients with refractory\u002Frelapsed (R\u002FR) acute myeloid leukemia (AML), and its effectiveness in other myeloid neoplasms (MN, such as myelodysplastic syndromes with excess blasts, MDS-IB) remains unknown, particularly with a scarcity of data from randomized controlled trials. This multicenter, randomized controlled study aims to prospectively compare the efficacy and safety of prophylactic versus preemptive DLI in patients with R\u002FR myeloid neoplasms undergoing allo-HSCT. The study will enroll patients with MN (including AML and MDS-IB, excluding Ph+ cases) undergoing allo-HSCT, who are in R\u002FR status at the time of transplant and achieve MRD-negative remission at 1 month post-transplant. Eligible patients must have no evidence of graft-versus-host disease (GVHD) or controlled GVHD, no severe infections, and no organ failure within 30-60 days post-transplant. One hundred patients will be enrolled in both the experimental and control groups. The primary endpoint is the relapse rate at 1 year post-randomization. Secondary endpoints include: 1-year leukemia-free survival and overall survival, and the incidence of bone marrow suppression, pancytopenia, GVHD, and infections following DLI. This study aims to explore strategies to reduce relapse rates and improve survival in patients with R\u002FR MN following allo-HSCT.",[237,26],"Acute Myeloid Leukemia",[239,240,241],"Donor lymphocyte infusion, DLI","Relapsed and refractory, R\u002FR","myeloid neoplasms, MN","2025-12-21",{"date":244,"type":38},"2026-01-06",{"date":246,"type":20},"2026-01-01",{"date":248,"type":20},"2028-06-30",{"name":250,"class":80},"Peking University People's Hospital",{"id":252,"slug":253,"hasResults":11,"nctId":254,"briefTitle":255,"officialTitle":256,"acronym":257,"eligibilityCriteria":258,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":189,"enrollmentInfo":259,"targetDuration":4,"studyType":21,"phases":261,"briefSummary":262,"conditions":263,"keywords":267,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":274,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":280,"locationsCount":81},"100611294","phase-2-optimization-of-post-transplantation-benadamustine-and-cyclophosphamide-in-patients-with-high-risk-myeloid-malignancies-and-a-partially-mismatched-donor-100611294","NCT07238712","Optimization of Post-transplantation Benadamustine and Cyclophosphamide in Patients With High-risk Myeloid Malignancies and a Partially Mismatched Donor","Optimization of Post-transplantation Benadamustine and Cyclophosphamide in Patients With High-risk Myeloid Malignancies and a Partially Mismatched Donor (APTBCy)","APTBCy","Inclusion Criteria:\n\n* Patients with indication for allogeneic hematopoietic stem cell transplantation\n* Patients with \\\u003C10\u002F10 HLA-matched related or unrelated donor available. The donor and recipient must be identical by the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1, and HLA-DQB1.\n* Peripheral blood stem cells or bone marrow as a graft source\n* Diagnosis:\n\nAcute myeloid leukemia Chronic myeloid leukemia, Ph+ Myelodysplastic Syndromes Myeloprolipherative neoplasms - High-risk disease defined as: Acute myeloid leukemia: \\>5% of clonal blasts in bone marrow despite adequate previous induction therapy or allogeneic stem cell transplantation Myelodysplastic Syndrome: \\>5% of blasts despite previous therapy Myeloid malignancy with with -7 or complex karyotype, or p53 mutation regardless of blast count in bone marrow Treatment-related myelodysplastic syndrome Second or subsequent allogeneic HCT after relapse of a myeloid malignancy Chronic myelomonocytic leukemia Myeloprolipherative neoplasms, unclassifiable\n\n\\- No severe concurrent illness\n\nExclusion Criteria:\n\n* Patients with indication for allogeneic hematopoietic stem cell transplantation\n* Patients with \\\u003C10\u002F10 HLA-matched related or unrelated donor available. The donor and recipient must be identical by the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1, and HLA-DQB1.\n* Peripheral blood stem cells or bone marrow as a graft source\n* Diagnosis:\n\nAcute myeloid leukemia Chronic myeloid leukemia, Ph+ Myelodysplastic Syndromes Myeloprolipherative neoplasms - High-risk disease defined as: Acute myeloid leukemia: \\>5% of clonal blasts in bone marrow despite adequate previous induction therapy or allogeneic stem cell transplantation Myelodysplastic Syndrome: \\>5% of blasts despite previous therapy Myeloid malignancy with with -7 or complex karyotype, or p53 mutation regardless of blast count in bone marrow Treatment-related myelodysplastic syndrome Second or subsequent allogeneic HCT after relapse of a myeloid malignancy Chronic myelomonocytic leukemia Myeloprolipherative neoplasms, unclassifiable\n\n\\- No severe concurrent illness",{"count":260,"type":20},60,[59],"Optimization of bendamustine-containg graft-versus-host disease (GVHD) prophylaxis to reduce the incidence of secondary haemophagocytic lymphohistiocytosis and GVHD",[63,264,26,265,266],"Chronic Myeloid Leukemia","Myeloprolipherative Neoplsm","Atypical Chronic Myeloid Leukemia",[268,269,270,271,272],"Post-transplantation cyclophosphamide","Post-transplantation bendamustine","graft-versus-host disease","abatacept","ruxolitinib","2025-11-16",{"date":275,"type":38},"2025-11-20",{"date":277,"type":38},"2025-05-10",{"date":279,"type":20},"2026-12-10",{"name":281,"class":80},"St. Petersburg State Pavlov Medical University",{"id":283,"slug":284,"hasResults":11,"nctId":285,"briefTitle":286,"officialTitle":287,"acronym":4,"eligibilityCriteria":288,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":289,"targetDuration":4,"studyType":21,"phases":291,"briefSummary":292,"conditions":293,"keywords":301,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":307,"lastUpdatePostDateStruct":308,"startDateStruct":310,"completionDateStruct":312,"leadSponsor":314,"locationsCount":81},"100546708","early-phase-1-darzalex-faspro-daratumumab-and-hyaluronidase-fihj-before-standard-desensitization-and-allogeneic-peripheral-blood-stem-cell-transplantation-in-adult-patients-at-high-risk-for-primary-graft-failure-secondary-to-donor-specific-antibodies-100546708","NCT06398457","Darzalex Faspro (Daratumumab and Hyaluronidase-fihj) Before Standard Desensitization and Allogeneic Peripheral Blood Stem Cell Transplantation in Adult Patients at High-risk for Primary Graft Failure Secondary to Donor Specific Antibodies","A Pilot Study of Darzalex Faspro (Daratumumab and Hyaluronidase-fihj) Before Standard Desensitization and Allogeneic Peripheral Blood Stem Cell Transplantation in Adult Patients at High-risk for Primary Graft Failure Secondary to Donor Specific Antibodies","Inclusion Criteria:\n\n1. Participates must meet all other institutional criteria for the planned reduced intensity conditioning allogeneic peripheral blood stem cell transplant (RIC alloHSCT) as defined in Johns Hopkins BMT Policy; all potential non-cord blood donor sources are included: matched related, haploidentical, matched unrelated, mismatched unrelated.\n2. Participants must be ≥18 years of age.\n3. Participants must have adequate organ function for undergoing RIC allogeneic peripheral blood stem cell transplant, and for undergoing a clinical trial.\n\n   a. Hematologic. i. White blood cell (WBC). ANC ≥ 500\u002Fmm3 (growth factor support allowed). ii. Hemoglobin. No specific cut-off. (PRBC transfusion allowed). iii. Platelets. Platelets ≥ 10,000\u002Fmm3 (platelet transfusion allowed). b. Liver. Bilirubin ≤ 3.0 mg\u002FdL (unless due to Gilbert's syndrome or hemolysis), and Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) \\\u003C 5x Upper limit of normal (ULN) c. Renal. Serum creatinine ≤ 2.0 mg\u002FdL. d. Cardiac. Left ventricular ejection fraction ≥ 35%. e. Pulmonary. FEV1 ≥ 50%.\n4. Subjects are eligible if there are high levels of Donor Specific Antibody levels based on protocol specific scoring system regardless of prior attempts at standard desensitization.\n5. Participants must have a no other readily available suitable alternative donor.\n6. All potential Participants must be pre-approved by BMT faculty consensus.\n7. Participants must have adequate willingness to participate in a clinical trial.\n\nExclusion Criteria:\n\n1. Previous exposure to Daratumumab-SC or other anti-CD38 therapy\n\n   1. Exposure to Daratumumab-SC or other anti-CD38 therapies (unless a re-treatment study)\n   2. Exposure to an investigational drug (including investigational vaccine) or invasive investigational medical device for any indication within 4 weeks or 5 pharmacokinetic half-lives, whichever is longer.\n   3. Focal radiation therapy within 14 days prior to beginning of planned RIC allogeneic peripheral blood stem cell transplant regimen with the exception of palliative radiotherapy for symptomatic management but not on measurable extramedullary plasmacytoma\n2. Chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) \\\u003C 50% of predicted normal. Note that FEV1 testing is required for participants suspected of having COPD and participants must be excluded if FEV1 is \\\u003C 50% of predicted normal.\n3. Moderate or severe persistent asthma within the past 2 years, or uncontrolled asthma of any classification. Note that participants who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed to participate.\n4. Known hypersensitivity or intolerance to boron or mannitol, sorbitol, corticosteroids, monoclonal antibodies or human proteins, or the excipients\n5. Diagnosis of multiple myeloma or Amyloid light-chain (AL) amyloidosis\n6. A planned myeloablative alloBMT or the planned use of bone marrow or cord blood as a stem cell source\n7. History of HIV infection at any time in past.\n8. Seropositive for hepatitis B (HBV) (defined by a positive test for hepatitis B surface antigen \\[HBsAg\\] positive, or antibodies to hepatitis B surface and\u002For core antigens \\[antiHBs or antiHBc, respectively\\] with hepatitis B virus \\[HBV\\]- DNA quantitation positive). Patients who are positive for antiHBs and\u002For antiHBc must have a negative polymerase chain reaction (PCR) for HBV-DNA quantitation result during screening. Patients with serologic findings suggestive of HBV vaccination (antiHBs positivity as the only serologic marker) AND a known history of prior HBV vaccination do not need to be tested for HBV DNA by PCR. Those who are PCR positive will be excluded.\n9. Seropositive for hepatitis C (except in the setting of a sustained virologic response (SVR), defined as aviremia at least 12 weeks after completion of antiviral therapy)\n10. Clinically significant cardiac disease, including:\n\n    1. Myocardial infarction within 6 months before RIC alloHSCT or unstable or uncontrolled disease\u002Fcondition related to or affection cardiac function (e.g., unstable angina, congestive heart failure, New York Heart Association Class III-IV)\n    2. Uncontrolled cardiac arrhythmia",{"count":290,"type":20},8,[192],"This research is being done to investigate the safety and effectiveness of Darzalex Faspro (daratumumab and hyaluronidase-fihj) (a monoclonal antibody that targets plasma cells that make antibodies) and whether it can lower donor specific antibodies (DSA) levels to low enough levels to permit patients to proceed with allogeneic peripheral blood transplant (alloBMT). Those being asked to participate have high DSA levels that puts those being asked to participate at high risk of rejecting the available donor's blood stem cells and making those being asked to participate ineligible to receive a stem cell transplant.",[294,295,63,26,296,64,297,298,299,66,264,300],"Hematologic Malignancy","Bone Marrow Transplant Rejection","Acute Lymphoblastic Leukemia (ALL), Adult","Aplastic Anemia","Lymphoma","Non Hodgkin Lymphoma","Myelofibrosis",[302,303,304,305,306],"DSA","donor specific antibodies","desensitization","BMT","allogeneic stem cell transplant","2025-09-25",{"date":309,"type":38},"2025-09-26",{"date":311,"type":38},"2024-09-19",{"date":313,"type":20},"2027-03",{"name":315,"class":80},"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins",{"id":317,"slug":318,"hasResults":11,"nctId":319,"briefTitle":320,"officialTitle":321,"acronym":4,"eligibilityCriteria":322,"healthyVolunteers":11,"sex":16,"minAge":323,"maxAge":324,"enrollmentInfo":325,"targetDuration":4,"studyType":21,"phases":327,"briefSummary":328,"conditions":329,"keywords":335,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":343,"lastUpdatePostDateStruct":344,"startDateStruct":346,"completionDateStruct":348,"leadSponsor":350,"locationsCount":81},"100507203","phase-2-cord-blood-transplant-in-adults-with-blood-cancers-100507203","NCT05884333","Cord Blood Transplant in Adults With Blood Cancers","Optimized Cord Blood Transplantation for the Treatment of High-Risk Hematologic Malignancies in Adults","Inclusion Criteria:\n\n* I. Acute myelogenous leukemia (AML):\n* Complete first remission (CR1) at high risk for relapse such as any of the following:\n\n  * Known prior diagnosis of myelodysplasia (MDS) or myeloproliferative disorder (MPD).\n  * Therapy-related AML.\n  * Presence of extramedullary leukemia at diagnosis.\n  * Requirement for 2 or more inductions to achieve CR1.\n  * Intermediate or high ELN2017 genetic risk AML.\n  * Any patient unable to tolerate consolidation chemotherapy as would have been deemed appropriate by the treating physician.\n  * Other high-risk features not defined above.\n* Complete second remission (CR2) or greater (CR2+).\n* Patients in morphologic remission with persistent cytogenetic, flow cytometric, or molecular aberrations are eligible\n\nII. Acute lymphoblastic leukemia (ALL):\n\n* Complete first remission (CR1) at high risk for relapse such as any of the following:\n\n  * Presence of any high-risk cytogenetic abnormalities such as t(9;22), t(1;19), t(4;11) or other MLL rearrangements (11q23) or other high-risk molecular abnormality.\n  * Failure to achieve MRD- complete remission after induction therapy.\n  * Persistence or recurrence of minimal residual disease on therapy.\n  * Any patient unable to tolerate consolidation and\u002For maintenance chemotherapy as would have been deemed appropriate by the treating physician.\n  * Other high-risk features not defined above.\n* Complete second remission (CR2) or greater (CR2+). Note: ALL with less than 5% blasts at time of transplant but persistent cytogenetic, flow cytometric or molecular aberrations are eligible.\n\nIII. Other acute leukemias: Acute leukemias of ambiguous lineage or mixed phenotype with less than 5% blasts. Leukemias in morphologic remission with persistent cytogenetic, flow cytometric or molecular aberrations are eligible.\n\nIV. Myelodysplastic Syndromes (MDS) and Myeloproliferative Disorders (MPD) other than myelofibrosis:\n\n* International prognostic scoring system (IPSS) risk score of INT-2 or high risk at the time of diagnosis.\n* Any IPSS risk category if life-threatening cytopenia(s) exists.\n* Any IPSS risk category with karyotype or genomic changes that indicate high risk for progression to acute myelogenous leukemia.\n* MDS\u002FMPD overlap syndromes without myelofibrosis.\n* MDS\u002F MPD patients must have less than 10% bone marrow myeloblasts and ANC \\> 0.2 (growth factor supported if necessary) at transplant work-up.\n\nV. Non-Hodgkin lymphoma (NHL) at high-risk of relapse or progression if not in remission:\n\nEligible patients with aggressive histologies (such as, but not limited to, diffuse large B-cell NHL, mantle cell NHL, and T-cell histologies) in CR by PET\u002FCT imaging.\n\no Eligible patients with indolent B-cell NHL (such as, but not limited to, follicular, small cell or marginal zone NHL) will have 2 nd or subsequent progression with PR or CR by PET\u002FCT imaging.\n\nVI. Blastic plasmacytoid dendritic cell neoplasm (BPDCN) in morphologic remission.\n\nOrgan Function and Performance Status Criteria:\n\n* Karnofsky score equal or greater than 80% (See Appendix B; inpatient Leukemia service transfers without discharge are acceptable provided patient has equivalent KPS as if were outpatient).\n* Calculated creatinine clearance \\> 70 ml\u002Fmin.\n* Bilirubin \\\u003C 1.5 mg\u002FdL (unless benign congenital hyperbilirubinemia or hemolysis).\n* ALT \\\u003C 3 x upper limit of normal (ULN).\n* Pulmonary function: Spirometry (FVC and FEV1) and corrected DLCO) \\> 60% predicted.\n* Left ventricular ejection fraction (MOD-bp)\\> 50%.\n* Albumin \\> 3.0.\n* Hematopoietic Cell Transplantation Comorbidity index (HCT-CI) ≤5.\n\nGraft criteria:\n\nTwo CB units will be selected according to current MSKCC CB unit selection algorithm. High resolution 8-allele HLA typing and recipient HLA antibody profile will be performed. Unit selection will occur based on HLA-match, total nucleated cell (TNC) and CD34+ cell dose adjusted per patient body weight. The bank of origin will also be considered. Donor specific HLA antibodies, if present, will also be taken into consideration and may influence the selection of the graft.\n\n* Each CB unit must be at least 3\u002F8 HLA-matched to the patient considering high-resolution 8-allele HLA typing. \\[Taken from the Cord Blood Summary\\]\n* Each CB unit will be required to have a cryopreserved TNC dose of at least 1.5 x 10\\^7 TNC\u002F recipient body weight (TNC\u002F kg). \\[Taken from the Cord Blood Summary\\]\n* Each CB unit will be required to have a cryopreserved CD34+ cell dose of at least 1.5 x 10\\^5 CD34+ cells\u002F recipient body weight (CD34+ cells\u002Fkg). \\[Taken from the Cord Blood Summary\\]\n* A minimum of one unit will be reserved as a backup graft. \\[Taken from the Cord Blood Summary\\]\n* Each CB unit will be required to be cryopreserved in standard cryovolume (24-27 ml\u002Fs per unit or per bag if unit in two bags) and be red blood cell depleted. \\[Taken from the Cord Blood Summary\\]\n\nExclusion Criteria:\n\n* Diagnosis of myelofibrosis or other malignancy with moderate-severe bone marrow fibrosis.\n* Patients with persistent with CNS involvement in CSF or CNS disease at time of screening\n* Prior checkpoint inhibitors\u002F blockade in the last 12 months.\n* Two prior stem cell transplants of any kind.\n* One prior autologous stem cell transplant within the preceding 12 months.\n* Prior allogeneic transplantation.\n* Prior involved field radiation therapy that would preclude safe delivery of 400cGy TBI in the opinion of Radiation Oncology.\n* Active and uncontrolled infection at time of transplantation.\n* HIV infection.\n* Seropositivity for HTLV-1.\n* Inadequate performance status\u002F organ function.\n* Pregnancy or breast feeding.\n* Patient or guardian unable to give informed consent or unable to comply with the treatment protocol including appropriate supportive care, long-term follow-up, and research tests.","21 Years","65 Years",{"count":326,"type":20},54,[59],"Cord blood transplants (CBT) are a standard treatment for adults with blood cancers. MSK has developed a standard (\"optimized\") practice for cord blood transplant (CBT). This optimized practice includes how patients are evaluated for transplant, the conditioning treatment (standard chemotherapy and total body irradiation therapy) given to prepare the body for transplant, the amount of stem cells transplanted, and how patients are followed during and after transplant.The purpose of this study is to collect information about participant outcomes after CBT following MSK's optimized practice. The researchers will look at outcomes of the CBT treatment such as side effects, disease relapse, GVHD, and immune system recovery after CBT treatment.",[330,331,332,26,333,334],"Acute Myelogenous Leukemia (AML)","Acute Lymphoblastic Leukemia (ALL)","Chronic Myelogenous Leukemia (CML)","Myeloproliferative Disorder","Non-Hodgkin's Lymphoma",[336,337,338,339,340,341,342],"Cord Blood Transplant","CYCLOPHOSPHAMIDE (CYTOXAN)","CYCLOSPORINE A","FLUDARABINE","MYCOPHENOLATE MOFETIL (MMF)","THIOTEPA","23-143","2025-09-05",{"date":345,"type":38},"2025-09-08",{"date":347,"type":38},"2023-05-22",{"date":349,"type":20},"2028-05-22",{"name":351,"class":80},"Memorial Sloan Kettering Cancer Center",{"id":353,"slug":354,"hasResults":11,"nctId":355,"briefTitle":356,"officialTitle":357,"acronym":358,"eligibilityCriteria":359,"healthyVolunteers":11,"sex":16,"minAge":360,"maxAge":4,"enrollmentInfo":361,"targetDuration":4,"studyType":21,"phases":363,"briefSummary":364,"conditions":365,"keywords":368,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":370,"lastUpdatePostDateStruct":371,"startDateStruct":373,"completionDateStruct":375,"leadSponsor":377,"locationsCount":81},"100431492","improving-cognitive-function-in-older-adults-undergoing-stem-cell-transplant-100431492","NCT04898790","Improving Cognitive Function in Older Adults Undergoing Stem Cell Transplant","Promoting Physical Activity to Improve Cognitive Function in Older Adults Undergoing Hematopoietic Cell Transplantation","PROACTIVE","Arm 1:\n\nInclusion Criteria for Participants:\n\n* age 60 years and older\n* have a diagnosis of hematological malignancy\n* have received autologous or allogeneic HCT within the prior 3-6 months\n* able to speak and read English\n* have provided written informed consent\n\nExclusion Criteria for Participants:\n\n* there are no exclusion criteria\n\nInclusion Criteria for Participants' Care-Partner:\n\n* age 19 years and older\n* able to speak and read English\n\nExclusion Criteria for Participants' Care-Partner:\n\n* there are no exclusion criteria\n\nInclusion Criteria for Transplant Team Member:\n\n* age 19 years and older\n* able to speak and read English\n\nExclusion Criteria for Transplant Team Member:\n\n* there are no exclusion criteria\n\nArms 2 and 3:\n\nInclusion Criteria for Participants:\n\n* age 55 years and older\n* have a diagnosis of hematological malignancy\n* planned to receive an autologous or allogeneic HCT\n* able to walk 4 meters as part of the Short Physical Performance Battery (with or without assistance)\n* (In Arm 3 only): willingness to be randomized to either initiate the physical activity intervention pre-HCT or following Day 180 post-HCT, and to follow the protocol for the group to which they have been assigned\n* able to speak and read English\n* have provided written informed consent\n\nExclusion Criteria for Participants:\n\n* development of chest pain, severe shortness of breath, or occurrence of other safety concerns during the physical performance measures (i.e. Short Physical Performance Battery)\n* is not cleared to participate in exercise by a physician\n\nIndividuals with the following current conditions\u002Fdiagnoses documented in medical history will be required to provide clearance for exercise from their cardiologist:\n\n* Myocardial infarctions in the past 3 months\n* Resting or unstable angina\n* Uncontrolled and\u002For serious arrhythmias\n* 3rd degree heart block\n* Acute congestive heart failure or ejection fraction \\\u003C30%\n* Clinically significant aortic stenosis\n\nIndividuals with the following conditions\u002Fdiagnoses will be required to provide clearance for exercise from their surgeon:\n\n* Hip fracture, hip or knee replacement, or spinal surgery in the past 3 months\n\n  * other medical, psychiatric, or behavioral factors that in the judgement of the principal investigator may interfere with study participation or the ability to follow either the intervention or the active control condition\n  * (In Arm 3 for those who agree to the voluntary measures of blood, saliva and MRI, there are additional exclusions to avoid conditions that may confound study outcomes):\n* history of residual brain abnormalities from prior severe traumatic brain injury (e.g. encephalomalacia) or other significant abnormalities documented on a recent brain MRI (e.g. brain cancer, large vessel strokes, residual subdural hematoma)\n* history of major stroke with obvious residual deficits\n* history of relapsing and remitting Multiple Sclerosis\n* active moderate to severe psychiatric symptoms due to primary psychiatric disorder\n\nInclusion Criteria for Participants' Care-Partner:\n\n* age 19 years and older\n* able to speak and read English\n* able to walk 4 meters as part of the Short Physical Performance Battery (with or without assistance)\n* have no medical contraindications for participating in light to moderate-intensity physical activity per PI review of medical history as reported on the care-partner medical history form\n\nExclusion Criteria for Participants' Care-Partner:\n\n* development of chest pain, severe shortness of breath, or occurrence of other safety concerns during the physical performance measures (i.e. Short Physical Performance Battery)\n* is not cleared to participate in exercise by a physician\n\nIndividuals with the following current conditions\u002Fdiagnoses documented in medical history will be required to provide clearance for exercise from their cardiologist:\n\n* Myocardial infarctions in the past 3 months\n* Resting or unstable angina\n* Uncontrolled and\u002For serious arrhythmias\n* 3rd degree heart block\n* Acute congestive heart failure or ejection fraction \\\u003C30%\n* Clinically significant aortic stenosis\n\nIndividuals with the following conditions\u002Fdiagnoses will be required to provide clearance for exercise from their surgeon:\n\no Hip fracture, hip or knee replacement, or spinal surgery in the past 3 months\n\n* other medical, psychiatric, or behavioral factors that in the judgement of the principal investigator may interfere with study participation or the ability to follow either the intervention or the active control condition\n\nInclusion Criteria for Transplant Team Member:\n\n* age 19 years and older\n* able to speak and read English\n\nExclusion Criteria for Transplant Team Member:\n\n* there are no exclusion criteria","19 Years",{"count":362,"type":20},88,[234],"Cancer and treatment-related cognitive changes, such as thinking or remembering, hinder resumption of normal routine and roles and worsen quality of life. Older adults undergoing hematopoietic cell transplantation (HCT) are at high-risk for cognitive impairment. Age is a risk factor for Alzheimer's Dementia (AD) and the hematological malignancies leading to HCT. There are shared mechanisms and interactions between AD and cancer-related cognitive decline (CRCD). Physical activity improves cognitive function in older adults and survivors of other cancers. This study hypothesizes that increasing physical activity can also improve cognitive function in this vulnerable population.\n\nThe study has two goals. The first is to adapt and test an evidence-based physical activity intervention, The Community Health Activities Model Program for Seniors II (CHAMPS II), in the HCT setting for adults 55 years and older. This will be done using semi-structured interview of up to 10 patients who have experienced the HCT process within the last 3 to 6 months with HCT care-team partners.\n\nThe second goal will explore the prevalence and impact of AD-neuropathology and inflammation on cancer-related cognitive decline (CRCD) in older adults undergoing HCT.",[366,298,64,26,367],"Leukemia","Myeloproliferative Neoplasm",[369],"Hematopoietic cell transplantation","2025-07-18",{"date":372,"type":38},"2025-07-23",{"date":374,"type":38},"2021-11-18",{"date":376,"type":20},"2027-07",{"name":378,"class":80},"University of Nebraska",{"id":380,"slug":381,"hasResults":11,"nctId":382,"briefTitle":383,"officialTitle":383,"acronym":384,"eligibilityCriteria":385,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":386,"targetDuration":4,"studyType":21,"phases":388,"briefSummary":389,"conditions":390,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":392,"lastUpdatePostDateStruct":393,"startDateStruct":395,"completionDateStruct":397,"leadSponsor":399,"locationsCount":81},"100584214","involvement-of-cda-andor-dck-metabolizing-enzymes-in-the-response-to-azacytidine-treatment-of-patients-with-hematologic-malignancies-100584214","NCT06886425","Involvement of CDA and\u002For dCK Metabolizing Enzymes in the Response to Azacytidine Treatment of Patients With Hematologic Malignancies","CDA-AML-MDS","Inclusion Criteria:\n\n* Patients over 18 years of age\n* Patients with acute myeloid leukemia\n* Patient with myelodysplastic syndrome\n* Person who has given non-opposition\n* Patient who has signed an authorization to perform a constitutional genetic analysis (in the context of care)\n* Need for effective contraception in patients of childbearing age\n\nExclusion Criteria:\n\n* Failure to obtain non-opposition\n* Adults under guardianship or safeguard of justice\n* Persons deprived of their liberty\n* Patient participating in another research project\n* Pregnancy in progress",{"count":387,"type":20},70,[234],"Until now, the development of personalized medicine in oncology has relied on the use of somatic biomarkers to help therapists choose the right molecule(s) to administer, based on the genetic and molecular profile of each hematological disease. In this project, investigators propose to extend the strategy of therapeutic individualization to the field of dosage targeting. Today, azacytidine is a standard treatment for patients with acute myeloid leukemia (AML) and\u002For myelodysplastic syndromes (MDS), usually as monotherapy. According to the treatment regimen, azacytidine is prescribed at a standard dose (DS=75mg\u002Fm²\u002Fd), administered subcutaneously every day for 7 days. The treatment cycle is repeated every 28 days.\n\nNo study has evaluated the relevance of \"a priori\" dose adjustment on an individual basis, according to each patient's pharmacogenetic data. In current practice, doses are adapted a posteriori, and reduced empirically, following the occurrence of observed toxicity (6 to 71% of patients) (Schuck A et al. 2017). This ex-post adjustment in the face of grade 3-4 toxicity is a loss of chance for the patient. Similarly, under-dosing patients for fear of toxicity is another loss of chance. Investigator's hypothesis is that the optimal dose of azacytidine depends not only on the characteristics of the patient's pathology (risk groups including cytogenetic and molecular biology data), but also on the patient's individual characteristics (genetic status of metabolic enzymes and transporters). A mathematical model of the PK\u002FPD type could, on the basis of early observations of circulating levels, be capable of rapidly predicting the pharmacodynamic repercussions in each patient, thus enabling rapid individualization of dosages. In the future, such a tool could make it possible to propose dosage adjustments rapidly after treatment initiation, before toxicity occurs, by predicting azacytidine exposure levels, themselves correlated with the patient's clinical condition.\n\nStudy design: In this open-label, paucicentric, non-randomized study, patients with AML and\u002For MDS, all of whom are receiving azacytidine-based chemotherapy as part of their standard treatment regimen, will be included. Each patient will be monitored for toxicities (EORTC), treatment response and progression-free survival. In addition to the standard care described above, each patient will undergo a series of constitutional genetic investigations conducted by NGS on markers linked to azacytidine pharmacokinetics (CDA, dCK). Another series of blood samples will be taken to calculate individual azacytidine pharmacokinetic parameters using a Bayesian approach.\n\nExpected results: This study should make it possible to correlate pharmacogenetics with patient plasma exposure, and ultimately improve the molecule's efficacy\u002Ftoxicity balance by personalizing dosage regimens, which until now have been carried out on an empirical basis.\n\nProspects: If the data are validated, a pre-therapeutic ADC assay could predict azacytidine pharmacodynamics and enable individual dose and\u002For dosage adjustment, as is the case with 5-FU and DPD.",[26,391],"Leukemia Acute Myeloid - AML","2025-03-19",{"date":394,"type":38},"2025-03-20",{"date":396,"type":38},"2021-06-14",{"date":398,"type":20},"2028-06-14",{"name":400,"class":80},"Assistance Publique Hopitaux De Marseille",{"id":402,"slug":403,"hasResults":11,"nctId":404,"briefTitle":405,"officialTitle":406,"acronym":4,"eligibilityCriteria":407,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":408,"targetDuration":4,"studyType":166,"phases":4,"briefSummary":409,"conditions":410,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":411,"lastUpdatePostDateStruct":412,"startDateStruct":414,"completionDateStruct":416,"leadSponsor":418,"locationsCount":81},"100574840","evaluation-of-response-to-biosimilar-erythropoietin-alfa-therapy-in-anemic-patients-with-myelodysplastic-syndrome-100574840","NCT06764511","Evaluation of Response to Biosimilar Erythropoietin Alfa Therapy in Anemic Patients With Myelodysplastic Syndrome","Valutazione Della Risposta Alla Terapia Con Eritropoietina Alfa Biosimilare Nei Pazienti Anemici Affetti da Sindrome Mielodisplastica","Inclusion Criteria:\n\nMDS patients with symptomatic anemia (pre-treatment hemoglobin \\\u003C 10g\u002FdL) who started treatment with biosimilar EPO alpha, diagnosed according to the WHO 2016 classification, and characterized by very low, low, or intermediate IPSS-R risk and a pre-treatment serum EPO level \\\u003C 500 U\u002FL, who started treatment with biosimilar EPO alpha at the U. O. of Hematology of IRCCS AOUBO during the period from 01\u002F06\u002F2018 to 31\u002F12\u002F2021.\n\n* Age ≥ 18 years at the time of enrollment\n* Acquisition of informed consent to study participation and data processing\n\nExclusion Criteria:\n\n* \\- Presence of other possible contributory causes of anemia (e.g., anemia from chronic inflammatory disease, hemolysis, hemorrhage)\n* Poor compliance with treatment\n* Very impaired general clinical condition (ECOG performance status \\> 3)\n* Concomitant treatment with antineoplastic cytotoxic drugs",{"count":260,"type":20},"The primary objective of this study is to describe the response to treatment with biosimilar EPO alpha in MDS patients who had already been treated with \"originator\" EPO alpha and were responsive, and in patients who started treatment with biosimilar EPO alpha",[26],"2025-01-02",{"date":413,"type":38},"2025-01-08",{"date":415,"type":38},"2024-08-30",{"date":417,"type":20},"2025-04-30",{"name":419,"class":80},"IRCCS Azienda Ospedaliero-Universitaria di Bologna",{"id":421,"slug":422,"hasResults":11,"nctId":423,"briefTitle":424,"officialTitle":425,"acronym":4,"eligibilityCriteria":426,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":427,"targetDuration":4,"studyType":21,"phases":429,"briefSummary":430,"conditions":431,"keywords":432,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":435,"lastUpdatePostDateStruct":436,"startDateStruct":438,"completionDateStruct":440,"leadSponsor":442,"locationsCount":444},"100383658","phase-1-a-phase-ib-study-of-apg-115-single-agent-or-in-combination-with-azacitidine-or-cytarabine-in-patients-with-aml-and-mds-100383658","NCT04275518","A Phase Ib Study of APG-115 Single Agent or in Combination With Azacitidine or Cytarabine in Patients With AML and MDS.","A Phase Ib Study to Investigate the Safety, Pharmacokinetics and Pharmacodynamics of APG-115 as a Single Agent or in Combination With Azacitidine or Cytarabine in Patients With Relapse\u002FRefractory AML and Relapsed\u002FProgressed High\u002FVery High Risk MDS","Inclusion Criteria:\n\n1. Patients with a diagnosis of histologically confirmed relapsed or refractory (R\u002FR) acute myeloid leukemia by WHO classification or relapsed\u002Fprogressed high\u002Fvery high risk MDS (score≥4.5) according to IPSS-R risk stratification\n2. Age \\>\u002F= 18 years.\n3. Adequate organ function\n4. Subject must have a projected life expectancy of at least 12 weeks.\n5. ECOG performance status of 0-1.\n6. Patient must have the ability to understand the requirements of the study and signed informed consent. A signed informed consent by the patient or his legally authorized representative is required prior to their enrollment on the protocol.\n7. Subject has a white blood cell count\\\u003C 50 × 109\u002FL. Note: Hydroxyurea is permitted to meet this criterion.\n\nExclusion Criteria:\n\n1. Subject has acute promyelocytic leukemia.\n2. Patients must not have had leukemia biotherapy 4 weeks prior to starting investigational drug, or less than 5 half-lives small molecular targeted drug therapy, or 28 days any anti-cancer therapy (whichever is longer)\n3. Uncontrolled intercurrent illness including, but not limited to active uncontrolled infection, symptomatic congestive heart failure (NYHA Class III or IV), unstable angina pectoris, clinically significant cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n4. Active infection requiring systemic antibiotic\u002Fantifungal medication, known clinically active hepatitis B or C, or HIV infection.\n5. Participants who have received allogeneic HSCT, or autologous HSCT within 12 months.\n6. Patients with active, uncontrolled CNS leukemia will not be eligible.\n7. Any prior systemic MDM2-p53 inhibitor treatment\n8. Any other condition or circumstance that would, in the opinion of the investigator, make the patient unsuitable for participation in the study.\n9. Subject has a history of other malignancies within 2 years prior to study entry, with the exception of:\n\n   * Adequately treated in situ carcinoma of the cervix uteri or carcinoma in situ of breast;\n   * Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin;\n   * Previous malignancy confined and surgically resected (or treated with other modalities) with curative intention: requires discussion with sponsor.",{"count":428,"type":20},102,[58],"Acute myeloid leukemia is a malignant disorder characterized by the rapid, uncontrolled proliferation of malignant clonal hematopoietic stem cells that accumulate as immature, undifferentiated cells (blasts) in the bone marrow and circulation.\n\nAPG-115 is a potent and orally active small-molecule MDM2 inhibitor, it binds to MDM2 protein and shows potent cell growth inhibitory activity in vitro with low nanomolar potencies in a subset of human cancer cell lines. APG-115 has demonstrated its strong antitumor activities with either daily or less frequent dosing-schedules in the acute leukemia xenograft models.\n\nThis is a phase 1b, open-label, three-stages study that will initially evaluate the safety and PK\u002FPD profile of APG-115 as a single agent, followed by a combination of APG-115 + azacytidine or cytarabine in R\u002FR AML or MDS subjects.\n\nPatients will continue treatment for maximally 6 cycles or until progression of disease or unacceptable toxicity is observed or administrative discontinuation whichever occurs first. Patients who continue to be benefit after 6 cycles' treatment will receive additional cycles of treatment until progression of disease, unacceptable toxicity is observed or administrative discontinuation. (As long as it is proven safe).",[63,26],[433,434,32],"APG-115","AML","2024-10-10",{"date":437,"type":38},"2024-10-15",{"date":439,"type":38},"2020-07-06",{"date":441,"type":20},"2025-12-31",{"name":443,"class":45},"Ascentage Pharma Group Inc.",14]