[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mds-myelodysplastic-syndrome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mds-myelodysplastic-syndrome":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,20,0,[8,47,78,100,127,150,193,221,247,268,297,333,373,396,419,442,464,483,508,529],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100146179","phase-2-allogeneic-hematopoietic-stem-cell-transplantation-for-severe-aplastic-anemia-and-other-bone-marrow-failure-syndromes-using-g-csf-mobilized-cd34-selected-hematopoietic-precursor-cells-co-infused-with-a-reduced-dose-of-non-mobilized-donor-t-cells-100146179",false,"NCT01174108","Allogeneic Hematopoietic Stem Cell Transplantation for Severe Aplastic Anemia and Other Bone Marrow Failure Syndromes Using G-CSF Mobilized CD34+ Selected Hematopoietic Precursor Cells Co-Infused With a Reduced Dose of Non-Mobilized Donor T-cells","Allogeneic Hematopoietic Stem Cell Transplantation for Severe Aplastic Anemia and Other Bone Marrow Failure Syndromes Using G-CSF Mobilized CD34+ Selected Hematopoietic Precursor Cells Co-Infused With a Reduced Dose of Non-Mobilized Donor T-Cells","* INCLUSION CRITERIA:\n* Recipient:\n\n  * Patients diagnosed with one of the following hematologic diseases which are associated with reasonable longevity, shown to be curable by allogeneic BMT but where concern for a high procedural mortality with conventional BMT may delay or prevent such treatment:\n\n    * 1\\) Paroxysmal nocturnal hemoglobinuria (PNH) associated with life-threatening thrombosis, and\u002For cytopenia, and\u002For transfusion dependence and\u002For recurrent and debilitating hemolytic crisis\n    * 2\\) Severe aplastic anemia (SAA) or pure red cell aplasia (PRCA \\[acquired or congenital\\]) with bone marrow cellularity \\\u003C30% (excluding lymphocytes) associated with RBC or platelet transfusion dependence and\u002For neutropenia (absolute neutrophil count \\\u003C=1000 cells\u002FuL or for patients receiving granulocyte transfusions, absolute neutrophil count \\\u003C=1000 cells\u002F uL before beginning granulocyte transfusions). in newly diagnosed patients and\u002For in patients who have failed immunosuppressive therapy.\n    * 3\\) Refractory anemia (RA) or RARS MDS patients who have associated transfusion dependence and\u002For neutropenia.\n  * Ages 4 to 80 (both inclusive), and weight \\>15 kg\n  * Availability of HLA identical or single HLA locus mismatched family donor or 10\u002F10 matched unrelated donor at the allelic level (HLA alleles A, B, C, DR, and DQ).\n  * 9\u002F10 donors where all the HLA sequences have the same antigen\u002Fpeptide binding domains in key exons to the patient. This can result in identical protein sequences between patient and donor. Allele mismatches in p and g groups can be considered acceptable due to the exact matching which exists in the binding domains.\n  * Telomere Length Testing\n  * Germline\u002FInherited gene panel in patients where a suspicion for a familial bone marrow failure syndrome (BMFS) exist, hTERC and hTERT, GATA2 mutation testing will be performed on protocol 04-H-0012 or performed elsewhere prior to enrolling on 04-H-0012.\n\nEXCLUSION CRITERIA:\n\n\\- Recipient: any of the following\n\n* Major anticipated illness or organ failure incompatible with survival from PBSC transplant\n* Diffusion capacity of carbon monoxide (DLCO) \\\u003C40% predicted (patients under the age of 10 may be excluded from this criterion if they have difficulty performing the test correctly and thus are unable to have their DLCO assessed) using DL Adj and DL\u002FVA\u002FAdj.\n* Left ventricular ejection fraction \\\u003C40% (evaluated by ECHO)\n* Serum creatinine greater than 2.5mg\u002Fdl or creatinine clearance less than 50 ml\u002Fmin by 24 hr urine collection\n* Serum bilirubin greater than 4 mg\u002Fdl, transaminases greater than 5 times the upper limit of normal\n* Pregnant or lactating\n* Fanconi s anemia (test to be performed at a CLIA-certified laboratory)\n* ECOG performance status of 3 or more (See NIH Bone \\& Marrow Transplant Consortium Supportive Care Guidelines for HSCT Recipients or Institutional Guidelines for bone and marrow transplants)\n* Other malignant diseases liable to relapse or progress within 5 years, with the exception of a separate hematologic malignancy where allogeneic stem cell transplant has been shown to be potentially curative.\n* Presence of an active infection not adequately responding to appropriate therapy.\n* Inability to comprehend the investigational nature of the study and provide informed consent. The procedure will be explained to subjects age 8 -17 years with formal consent being obtained from parents or legal guardian.\n\nINCLUSION CRITERIA:\n\n-Related Donor:\n\n* Related donor deemed suitable and eligible, and willing to donate, per clinical evaluations who are additionally willing to donate blood samples for research. Related donors will be evaluated in accordance with existing Standard Policies and Procedures for determination of eligibility and suitability for clinical donation. Note that participation in this study is offered to all related donors, but study participation is not required for a donor to make a stem cell donation, so it is possible that not all related donors will enroll onto this study\n* Age greater than or equal to 4 and less than or equal to 80 years old\n\nEXCLUSION CRITERIA:\n\n-Related Donor: None\n\nINCLUSION CRITERIA \\& EXCLUSION CRITERIA: Unrelated Donor\n\n\\- The NMDP unrelated donor inclusion criteria will be used as outlined in document (http:\u002F\u002Fbethematch.org\u002FWorkArea\u002FDownloadAsset.aspx?id=1960). Donor eligibility will be completed per NMDP standards and in accordance with most recent and stringent FDA guidelines.","ALL","4 Years","80 Years",{"count":20,"type":21},120,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Background:\n\n* Stem cell transplants from related donors (allogenic stem cell transplants) can be used to treat individuals with certain kinds of severe blood diseases or cancers, such as severe anemia. Allogenic stem cell transplants encourage the growth of new bone marrow to replace that of the recipient. Because stem cell transplants can have serious complications, researchers are interested in developing new approaches to stem cell transplants that will reduce the likelihood of these complications.\n* By reducing the number of white blood cells included in the blood taken during the stem cell collection process, and replacing them with a smaller amount of white blood cells collected prior to stem cell donation, the stem cell transplant may be less likely to cause severe complications for the recipient. Researchers are investigating whether altering the stem cell transplant donation procedure in this manner will improve the likelihood of a successful stem cell transplant with fewer complications.\n\nObjectives:\n\n\\- To evaluate a new method of stem cell transplantation that may reduce the possibly of severe side effects or transplant rejection in the recipient.\n\nEligibility:\n\n* Recipient: Individuals between 4 and 80 years of age who have been diagnosed with a blood disease that can be treated with allogenic stem cell transplants.\n* Donor: Individuals between 4 and 80 years of age who are related to the recipient and are eligible to donate blood. OR unrelated donors found through the National Marrow Donor Program.\n\nDesign:\n\n* All participants will be screened with a physical examination and medical history.\n* DONORS:\n* Donors will undergo an initial apheresis procedure to donate white blood cells.\n* After the initial donation, donors will receive injections of filgrastim to release bone marrow cells into the blood.\n* After 5 days of filgrastim injections, donors will have apheresis again to donate stem cells that are present in the blood.\n* RECIPIENTS:\n* Recipients will provide an initial donation of white blood cells to be used for research purposes only.\n* From 7 days before the stem cell transplant, participants will be admitted to the inpatient unit of the National Institutes of Health Clinical Center and will receive regular doses of cyclophosphamide, fludarabine, and anti-thymocyte globulin to suppress their immune system and prepare for the transplant.\n* After the initial chemotherapy, participants will receive the donated white blood cells and stem cells as a single infusion.\n* After the stem cell and white blood cell transplant, participants will have regular doses of cyclosporine and methotrexate to prevent rejection of the donor cells. Participants will have three doses of methotrexate within the week after the transplant, but will continue to take cyclosporine for up to 4 months after the transplant.\n* Participants will remain in inpatient care for up to 1 month after the transplant, and will be followed with regular visits for up to 3 years with periodic visits thereafter to evaluate the success of the transplant and any side effects.",[27,28],"Severe Aplastic Anemia","MDS (Myelodysplastic Syndrome)",[30,27,31,32,33],"Myelodysplastic Syndrome (MDS)","Pure Red Cell Aplasia","Paroxysmal Nocturnal Hemoglobinuria (PNH)","Miltenyi CD34 Reagent System","RECRUITING","2026-06-27",{"date":37,"type":38},"2026-06-30","ACTUAL",{"date":40,"type":38},"2010-12-10",{"date":42,"type":21},"2028-06-30",{"name":44,"class":45},"National Heart, Lung, and Blood Institute (NHLBI)","NIH",2,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":77},"100642715","haplo-cord-hsct-for-amlmds-100642715","NCT07588360","Haplo-Cord HSCT for AML\u002FMDS","Haploidentical Combined With Cord Blood Hematopoietic Stem Cell Transplantation for Acute Myeloid Leukemia and Myelodysplastic Syndromes: A Prospective, Multicenter Clinical Study","Inclusion Criteria:\n\n* Age between 14 and 60 years, with no gender restriction.\n* Intermediate- or high-risk AML in first complete remission (CR1).\n* AML in second or subsequent complete remission (≥ CR2).\n* Relapsed or refractory AML.\n* Low-risk AML meeting any of the following: Failure to achieve a ≥3-log reduction in RUNX1::RUNX1T1 transcript level compared with baseline after 2 consolidation cycles, or loss of major molecular remission (MMR) within 6 months; CBFB::MYH11\u002FABL ratio \\> 0.1% at any time point after 2 consolidation cycles in patients with CBFB::MYH11-rearranged AML; Presence of D816 KIT mutation in patients with CBFB::MYH11-rearranged AML; Flow cytometry-positive MRD at any time point after 2 consolidation cycles in patients with CEBPA double-mutant AML; Persistently positive MRD after chemotherapy in patients with NPM1-mutated AML.\n* Intermediate-2 or high-risk MDS according to the IPSS scoring system.\n* Adequate general health status and ability to tolerate hematopoietic stem cell transplantation.\n* Provision of signed informed consent and willingness to comply with study-required follow-up and examinations.\n\nExclusion Criteria:\n\n* Prior history of other hematopoietic stem cell transplantation.\n* History of ex vivo T-cell-depleted stem cell transplantation.\n* Survival duration of less than 1 month after transplantation.\n* Severe organ dysfunction, including significant impairment of hepatic, renal, cardiac, or pulmonary function.\n* Active severe infection, such as uncontrolled pneumonia, sepsis, or other systemic infections.\n* History of severe hypersensitivity reactions to study medications, including cyclophosphamide or anti-thymocyte globulin (ATG).\n* Presence of severe psychiatric disorders or cognitive impairment that precludes compliance with study treatment and follow-up.\n* Pregnant or lactating women.\n* Concurrent malignancy of other organ system.\n* Any other medical conditions deemed inappropriate for study participation by the treating investigators.","14 Years","60 Years",{"count":57,"type":21},82,[59],"NA","This study aims to investigate the clinical efficacy of haploidentical-cord blood hematopoietic stem cell transplantation in patients with acute myeloid leukemia (AML) and high-risk myelodysplastic syndromes (MDS), and to analyze the impact of different engraftment patterns (haploidentical engraftment versus cord blood engraftment) on clinical outcomes. By comparing the efficacy of haploidentical-cord blood transplantation in different subtypes of AML and MDS, this research will explore its unique advantages and comparative effectiveness relative to conventional transplantation strategies, so as to provide new evidence for clinical practice.\n\nSpecific research objectives I. To evaluate the efficacy of haploidentical-cord blood hematopoietic stem cell transplantation for AML and high-risk MDS, including the speed of hematopoietic recovery, immune tolerance, and long-term survival rates.\n\nII. To compare the effects of different engraftment patterns (haploidentical engraftment vs. cord blood engraftment) on quality of life, immune tolerance, early complications, and long-term prognosis.\n\nIII. To identify the clinical advantages and indications of haploidentical-cord blood transplantation through data analysis, and to provide a theoretical basis for clinical decision-making.\n\nNovelty of the Study I. Innovation in Hematopoietic Stem Cell Infusion Schedule The present study employs a sequential infusion strategy: haploidentical stem cells are infused on Day 0, and umbilical cord blood cells are infused on Day +6 after transplantation.In contrast to the conventional approach used at most domestic and international centers (including the uzhou Protocol), in which both stem cell sources are infused simultaneously on Day 0, the current protocol delays cord blood infusion. This design confers potential advantages for immune reconstitution and long-term cord blood engraftment.\n\nII. Unique Myeloablative Conditioning Regimen\n\nThe conditioning regimen used in this study is as follows:\n\nFludarabine 25 mg\u002Fm² for 5 days, Cytarabine 2 mg\u002Fm² for 5 days, intravenous Busulfan 3.2 mg\u002Fkg for 3 days, ATG 5 mg\u002Fm² for 2 days, Melphalan 60 mg\u002Fm² for 2 days, and CTX 50.0 mg\u002Fkg daily for 2 days.\n\n(For patients in complete remission (CR) with negative MRD before transplantation, Fludarabine and Cytarabine are administered for 3 days instead of 5 days.) Distinct from regimens at other centers, our team administers cyclophosphamide within the critical window after haploidentical stem cell infusion but before cord blood infusion, establishing a novel sequential conditioning model. This approach balances myeloablative intensity and immunomodulation, creating a favorable environment for subsequent long-term cord blood engraftment.\n\nIII. Engraftment Outcomes and Clinical Value Preliminary clinical experience demonstrates that haplo-cord sequential transplantation following the FA5Cy2Bu3 conditioning regimen combined with low-dose ATG\u002FPTCY can achieve long-term cord blood engraftment in approximately 50% of patients.\n\nBy comparison, other domestic protocols (e.g., the Suzhou Protocol) rarely result in sustained cord blood engraftment.\n\nAchievement of long-term cord blood engraftment is clinically meaningful for reducing relapse rates, lowering the incidence and severity of graft-versus-host disease (GVHD), and improving patient prognosis. These outcomes represent a key advantage of the present protocol.",[28,62],"AML (Acute Myeloid Leukemia)",[64,65,66],"Acute Myeloid Leukemia(AML)","Myelodysplastic Syndrome(MDS)","haplo-cord HSCT","2026-06-08",{"date":69,"type":38},"2026-06-10",{"date":71,"type":38},"2025-10-20",{"date":73,"type":21},"2029-06-30",{"name":75,"class":76},"Fujian Medical University Union Hospital","OTHER",4,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":16,"minAge":85,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":22,"phases":87,"briefSummary":88,"conditions":89,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":99},"100637763","phase-2-ivosidenib-as-maintenance-therapy-in-transplant-ineligible-idh1-mutated-aml-and-hr-mds-100637763","NCT07607418","Ivosidenib as Maintenance Therapy in Transplant-Ineligible IDH1-mutated AML and HR-MDS","A Phase II, Multicenter, Open-label Clinical Study of Ivosidenib as Maintenance Therapy in Patients With IDH1-mutated AML and High-risk MDS Who Are Ineligible for Transplantation (IVORY-MAST)","Inclusion Criteria:\n\n* Age ≥18 years, male or female.\n* Molecularly confirmed diagnosis of IDH1-mutated acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS).\n* Achieved complete remission (CR) or partial remission (PR) after induction therapy.\n* Ineligible for allogeneic hematopoietic stem cell transplantation (allo-HSCT).\n* Eastern Cooperative Oncology Group (ECOG) performance status score ≤2.\n* Signed informed consent.\n* For women of childbearing potential: must have practiced contraception for at least one month prior to screening and commit to using contraception throughout the study period and for the required period after study completion.\n* Female participants of childbearing potential and male participants with female partners of childbearing potential must agree to use highly effective methods of contraception from the time of signing informed consent until 180 days after the last dose of the study drug.\n\nExclusion Criteria:\n\nParticipants with any of the following criteria will be excluded from the study:\n\n* Prior treatment with an IDH1 inhibitor.\n* Diagnosis of M3 subtype (acute promyelocytic leukemia, APL).\n* Presence of severe hepatic or renal dysfunction.\n* Active infection or other serious comorbidities.\n* Major surgery within 28 days prior to the first dose, or planned surgery during the study period.\n* Diagnosis of any other malignancy within 5 years prior to the first dose, with the exception of early-stage malignancies that have been cured by radical treatment, such as carcinoma in situ of the lung, non-melanoma skin cancer, basal cell or squamous cell carcinoma of the skin, or cervical carcinoma in situ. Whether to exclude such patients will be determined by the investigator's assessment.\n* Severe cardiovascular disease, such as New York Heart Association (NYHA) class 2 heart failure, unstable angina, unstable arrhythmia, myocardial infarction or cerebrovascular accident within 3 months prior to randomization.\n* Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS); active hepatitis B (HBV DNA≥1000 IU\u002Fml); hepatitis C (positive for anti-HCV antibodies and HCV-RNA above the lower limit of detection of the assay); or co-infection with hepatitis B and hepatitis C.\n* Known history of psychoactive substance abuse or drug addiction.\n* Presence of any other serious physical or mental illness, or abnormal laboratory findings that may increase the risk of study participation, interfere with the study results, or make the patient unsuitable for study participation in the opinion of the investigator.\n* Inability to swallow, intestinal obstruction, or other factors affecting drug administration or absorption.\n* Previous concomitant treatment with both drugs of the combination therapy targeting the same pathway as in this study.\n* History of allergy to the study drug or any of its excipients.","18 Years",{"count":5,"type":21},[24],"This study will explore the efficacy and safety of ivosidenib as maintenance therapy in patients with IDH1-mutated AML and high-risk MDS who are ineligible for transplantation, along with accompanying molecular biomarker research. Patients who meet the eligibility criteria will receive ivosidenib treatment until disease progression or unacceptable toxicity. This study will provide an effective maintenance treatment option for transplant-ineligible patients with IDH1-mutated AML and high-risk MDS.",[62,28],"2026-05-19",{"date":92,"type":38},"2026-05-26",{"date":94,"type":21},"2026-05-22",{"date":96,"type":21},"2027-12-30",{"name":98,"class":76},"Ruijin Hospital",1,{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":16,"minAge":85,"maxAge":4,"enrollmentInfo":108,"targetDuration":4,"studyType":110,"phases":4,"briefSummary":111,"conditions":112,"keywords":115,"overallStatus":118,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":119,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":99},"100638161","forecasting-relapse-outcomes-with-alloheme-based-risk-detection-in-post-allo-hct-amlmds-patients-forward-100638161","NCT07607327","Forecasting Relapse Outcomes With AlloHeme-based Risk Detection in Post-Allo-HCT AML\u002FMDS Patients (FORWARD)","Forecasting Relapse Outcomes With AlloHeme-based Risk Detection in Post-Allo-HCT AML\u002FMDS Patients (FORWARD): A Multicenter, Prospective Observational Cohort Study in US Transplant Centers","FORWARD","Inclusion Criteria:\n\n1. Adults aged 18 years or above.\n2. The participant must have one of the following diseases: AML or MDS (including CMML) and be eligible for allogeneic hematopoietic stem cell transplant. For participants with active disease (\\> 5% blasts) before HCT, the treating physician must have the intent to perform a bone marrow examination at day 30 post-HCT as SOC patient management to confirm complete remission (\\\u003C5% blasts).\n3. Participant must receive an allo-HCT from an HLA-matched related or unrelated donor, an HLA-mismatched donor, or a haploidentical donor.\n4. Participant can be enrolled before, at, or up to 1-month post-allo-HCT as long as the participant is in complete remission (CR) at Day 30 and that a recipient pre-transplant or donor sample is available for baseline genotyping (reference). If the reference sample is unavailable or fails testing, the buccal swab collected at Day 30 may be used as the reference sample.\n5. Myeloablative or reduced intensity\u002Fnon-myeloablative conditioning except T-cell depleting therapies (Ex-vivo T cell depletion, CD34 selected graft, use of anti-thymocyte globulin or alemtuzumab).\n6. Any graft versus host disease (GVHD) prophylaxis regimen.\n7. Willing and able to provide written informed consent.\n8. Willing and able to comply with study visits and procedures, including scheduled sample collections and clinical assessments\n\nExclusion Criteria:\n\n1. History of prior allo-HCT or any prior solid organ transplant.\n2. Syngeneic donor (identical twin).\n3. T cell depleted transplant (Ex-vivo T cell depletion, CD34 selected graft, use of antithymocyte globulin or alemtuzumab in the conditioning regimen)\n4. Cord blood graft.\n5. Pregnancy\n6. Any condition that, in the investigator's opinion, would interfere with the participant's ability to comply with study procedures or jeopardize their safety.\n7. Concurrent participation in an interventional or maintenance clinical trial for post allo-HCT relapse prevention; co-enrollment with other trials, such as those intended for GVHD \u002F infection prevention or improving supportive care, is allowed.",{"count":109,"type":21},400,"OBSERVATIONAL","AlloHeme is a blood-based monitoring test developed by the CareDx laboratory that utilizes NGS technology coupled with a proprietary algorithm to predict the likelihood of a relapse in post-allo-HCT AML\u002FMDS patients. The technology analyzes 405 single nucleotide polymorphisms (SNPs) selected from across all somatic chromosomes between the donor and the recipient. Pre-transplant DNA is obtained from donor and\u002For recipient to identify specific donor and recipient SNPs (baseline samples). Post-transplant blood samples are obtained and compared to the baseline sample profiles to precisely calculate the percentage chimerism of recipient cells in the blood samples using a proprietary quantitative method and unique dual indexing that optimizes recipient DNA at trace levels. This approach enables highly accurate and reproducible chimerism measurement with a limit of detection down to 0.02%. The AlloHeme test leverages a proprietary algorithm that integrates this multi-analyte longitudinal chimerism data with post-transplant time points to predict the likelihood of a clinical relapse for AML\u002FMDS patients following an allo-HCT.",[113,28,114],"AML (Acute Myelogenous Leukemia)","CMML",[116,117],"Chimerism","Relapse","NOT_YET_RECRUITING",{"date":92,"type":38},{"date":121,"type":21},"2026-08-31",{"date":123,"type":21},"2030-08-31",{"name":125,"class":126},"CareDx","INDUSTRY",{"id":128,"slug":129,"hasResults":11,"nctId":130,"briefTitle":131,"officialTitle":131,"acronym":4,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":16,"minAge":85,"maxAge":4,"enrollmentInfo":133,"targetDuration":135,"studyType":110,"phases":4,"briefSummary":136,"conditions":137,"keywords":4,"overallStatus":118,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":99},"100636107","dresden-mds-registry-with-an-accompanying-biomaterial-collection-100636107","NCT07561385","Dresden MDS Registry With an Accompanying Biomaterial Collection","Inclusion Criteria:\n\n* Diagnosis of myelodysplastic syndrome (MDS), MDS\u002FMPN overlap syndrome or evidence of myelodysplastic precursor syndrome, defined as clonal haematopoiesis without cytopenia (clonal haematopoiesis of indeterminate potential, CHIP) or clonal haematopoiesis with cytopenia (clonal cytopenia of undetermined significance, CCUS) in accordance with current WHO criteria\n* Age ≥18 years\n* Submission of a signed consent form for participation in the MDS Registry\n\nExclusion Criteria:\n\n* No exclusion criteria have been established with regard to the registry's primary objective. In particular, patients with comorbidities and those receiving non-curative treatment may be explicitly included in order to provide a realistic picture of actual care practices\n* Inclusion in the registry is excluded in cases where a written consent form is not available or where patients are unable to understand the nature and implications of participating in this registry",{"count":134,"type":21},500,"5 Years","A registry for the study of the epidemiology, clinical course, and progression of myelodysplastic neoplasms (MDS), myelodysplastic\u002Fmyeloproliferative neoplasms (MDS\u002FMPN overlap syndromes), and their precursor syndromes (CHIP, CCUS)",[28,138,139,140],"MDS\u002FMyeloproliferative Neoplasm (MPN) Overlap Syndrome","CHIP","CCUS Clonal Cytopenia of Undetermined Significance","2026-04-24",{"date":143,"type":38},"2026-05-01",{"date":145,"type":21},"2026-06",{"date":147,"type":21},"2036-06",{"name":149,"class":76},"Technische Universität Dresden",{"id":151,"slug":152,"hasResults":11,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":4,"eligibilityCriteria":156,"healthyVolunteers":11,"sex":16,"minAge":157,"maxAge":158,"enrollmentInfo":159,"targetDuration":4,"studyType":22,"phases":161,"briefSummary":163,"conditions":164,"keywords":178,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":99},"100580604","phase-1-phase-12-cd45ra-depleted-stem-cell-addback-to-prevent-viral-or-fungal-infections-post-tcrabcd19-depleted-hsct-100580604","NCT06839456","Phase 1\u002F2: CD45RA Depleted Stem Cell Addback to Prevent Viral or Fungal Infections Post TCRab\u002FCD19 Depleted HSCT","Phase 1\u002F2 Study: CD45RA Depleted Peripheral Stem Cell Addback to Prevent Viral and Fungal Infections Following Alternative Donor TCRab\u002FCD19 Depleted Hematopoietic Stem Cell Transplant","Inclusion Criteria:\n\n1. Disease for which allogeneic HSCT may be curative.\n2. Remission status of hematologic malignancies and additional disease-specific eligibility determinations will be according to standards of practice within the CHOP Cellular Immunotherapy and Transplant Program (CTTS).\n3. Patients must be 25 years of age and less\n4. Evaluation for organ and infectious status as per our CTTS standard operating procedure.\n5. Signed consent by parent\u002Fguardian or able to give consent if 18 years of age and older.\n6. Participants of childbearing potential must have a negative pregnancy test as per institutional SOP.\n\nExclusion Criteria:\n\n1. Patients who have performance score less than 60.\n2. No suitable donor available for mobilized peripheral stem cells.\n3. Patients with Hodgkin lymphoma or non-Burkitt, non-lymphoblastic lymphoma.\n4. Planned receipt of alemtuzumab during conditioning.\n5. Patients with an available 10\u002F10 HLA matched sibling donor.\n6. Patients who do not meet institutional disease, organ or infectious criteria.\n\nDonor selection and eligibility:\n\n1. Unrelated donor meets National Marrow Donor Program criteria for donation.\n2. Related donor (at least haploidentical) willing and able to donate mobilized peripheral stem cells.\n3. HLA testing\u002Fmatching\n\n   * HLA testing to be done by molecular methods for A, B, C, DRB1, DQB1\n   * Related donor: Must be ≥ 5\u002F10 match\n   * Unrelated donor: 10\u002F10 or 9\u002F10 match\n   * KIR typing for haploidentical donor for hematologic malignancies\n   * Donor specific HLA antibodies (DSA) should be assessed for all subjects receiving an HLA mismatched graft (≤ 9\u002F10).\n4. Donor must be willing to undergo granulocyte colony stimulating factor (GCSF) mobilization and peripheral blood stem cell collection\n5. Donors must be willing to sign consent to participate in this study.","1 Month","25 Years",{"count":160,"type":21},100,[162,24],"PHASE1","The major morbidities of allogeneic hematopoietic stem cell transplant (HSCT) using donors that are not human leukocyte antigen (HLA) matched siblings are graft vs host disease (GVHD) and life- threatening infections. T cell receptor alpha beta (TCRαβ) T lymphocyte depletion and CD19+ B lymphocyte depletion of alternative donor hematopoietic stem cell (HSC) grafts is effective in preventing GVHD, but immune reconstitution may be delayed, increasing the risk of infections. The central hypothesis of this study is that an addback of CD45RO memory T lymphocytes, derived from a fraction of the original donor peripheral stem cell product depleted of CD45RA naïve T lymphocytes, will accelerate immune reconstitution and help decrease the risk of infections in TCRab\u002FCD19 depleted PSCT.",[165,166,167,168,28,169,170,171,172,173,174,175,176,177],"Leukemia","High Risk Acute Lymphoblastic Leukemia","High Risk Acute Myeloid Leukemia","Relapse Leukemia","Relapsed Non-Hodgkin Lymphoma","Acquired Aplastic Anemia","Inherited BMF Syndrome","Immunodeficiency","Primary Immune Regulatory Disorder","Hemoglobinopathies","Bone Marrow Failure","Inborn Errors of Metabolism","HLH",[179,180,181,182,183],"alpha beta T cell depletion","CD45RA","CD45RO","GVHD prevention","Memory T cells","2026-04-13",{"date":186,"type":38},"2026-04-15",{"date":188,"type":38},"2025-03-21",{"date":190,"type":21},"2032-03",{"name":192,"class":76},"Children's Hospital of Philadelphia",{"id":194,"slug":195,"hasResults":11,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":4,"eligibilityCriteria":199,"healthyVolunteers":11,"sex":16,"minAge":200,"maxAge":4,"enrollmentInfo":201,"targetDuration":4,"studyType":22,"phases":203,"briefSummary":204,"conditions":205,"keywords":207,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":214,"lastUpdatePostDateStruct":215,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":219,"locationsCount":99},"100631444","a-single-arm-prospective-study-of-a-clad-labu-conditioning-regimen-in-hsct-for-rr-mdsaml-in-elderly-patients-100631444","NCT07500753","A Single-arm, Prospective Study of a Clad-LABU Conditioning Regimen in HSCT for R\u002FR MDS\u002FAML in Elderly Patients","A Single-arm, Prospective Study of a Cladribine-Bridged Lisaftolax and Busulfan Conditioning Regimen in Allogeneic Hematopoietic Stem Cell Transplantation for Relapsed\u002FRefractory Myelodysplastic Syndromes and Acute Myeloid Leukemia in Elderly Patients","Inclusion Criteria:\n\n* Age ≥ 50years.\n* Meet the 2022 World Health Organization (WHO) diagnostic criteria for acute myeloid leukemia (AML),MDS, and be diagnosed with relapsed\u002Frefractory AML after treatment, fulfilling any of the following definitions:\n* Relapsed AML: Reappearance of leukemic cells in peripheral blood, bone marrow blasts \\>5% (excluding other causes such as bone marrow regeneration after consolidation chemotherapy), or extramedullary infiltration of leukemic cells after achieving complete remission (CR or CRi).\n* Refractory AML: Newly diagnosed cases that failed to respond after 2 courses of standard therapy; patients who relapsed within 12 months after consolidation therapy following CR; patients who relapsed after 12 months but failed to respond to conventional chemotherapy; patients with 2 or more relapses; persistent extramedullary leukemia.\n* MDS:Myelodysplastic Neoplasms (MDS)MDS are a group of clonal hematopoietic stem cell disorders characterized by: Dysplastic hematopoiesis (abnormal development of blood cells in the bone marrow); Cytopenias (one or more lineages of blood cells are reduced in number); Increased risk of transformation to acute myeloid leukemia (AML).Key diagnostic criteria (per WHO 2022 classification): Persistent cytopenia(s) for ≥4 months (unless specific genetic abnormalities are present); Morphological dysplasia in ≥10% of cells in one or more lineages; Presence of MDS-defining genetic abnormalities (e.g., SF3B1 mutation, isolated del(5q), TP53 biallelic alteration).\n* Cardiac, hepatic, and renal function test results within the following limits:\n\nAlanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × upper limit of normal (ULN);Total bilirubin ≤ 3 × ULN;Serum creatinine ≤ 2 × ULN or creatinine clearance ≥ 40 mL\u002Fmin;Left ventricular ejection fraction (LVEF) measured by echocardiography or multigated acquisition (MUGA) scan within the normal range (\\>50%).\n\n* Have a suitable allogeneic donor.\n* Expected survival ≥ 1 month.\n* Karnofsky Performance Status (KPS) ≥ 60%, Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;\n* The patient understands the study protocol and voluntarily signs the informed consent form.\n\nExclusion Criteria:\n\n* Patients had serious adverse reactions to investigational drugs such as allergies;\n* Patients with a history of immunodeficiency, or other acquired or congenital diseases, immunodeficiency diseases, and a history of organ transplantation;\n* Patients with hypertension, ventricular arrhythmia requiring clinical intervention, acute coronary syndrome, congestive heart failure, stroke, or other grade III or higher cardiovascular events within 6 months;\n* Patients received Class II or higher surgery within 4 weeks prior to enrollment;\n* Patient has an active and difficult-to-control infection, including but not limited to active fungal, bacterial, or viral infections that require systemic treatment, such as active HIV, hepatitis B or C;\n* Patient has active central nervous system leukemia infiltration;\n* Pregnant or lactating patients;\n* Patient is currently participating in another clinical studies;\n* Other conditions where the investigator deems the patient unsuitable for inclusion.","50 Years",{"count":202,"type":21},30,[59],"Acute myeloid leukemia (AML) is one of the most common hematologic malignancies. With increasing life expectancy and the aging of society, the incidence of AML in the elderly population is rising. The prognosis of elderly AML patients is significantly worse than that of younger patients: the 5-year overall survival rate in patients over 60 years is less than 20%, while the median survival in patients over 80 years is only 3-6 months . Improving the overall prognosis of elderly AML has become a hot topic in current hematology research.\n\nHematopoietic stem cell transplantation (HSCT) is a therapeutic approach that involves intravenous infusion of hematopoietic stem cells with the goal of restoring bone marrow and immune function. Although several studies have focused on allo-HSCT in elderly patients, factors affecting transplant outcomes remain controversial, influencing clinical decision-making. Julian et al. retrospectively analyzed 103 elderly patients with relapsed\u002Frefractory AML who underwent allogeneic transplantation, showing that high-dose melphalan sequential chemotherapy was effective and well tolerated in elderly AML patients, with a 3-year overall survival rate exceeding 40%; disease prognosis was closely related to donor source and pre-transplant leukemic burden . Furthermore, studies on haploidentical hematopoietic stem cell transplantation (haplo-HSCT) in elderly patients are limited. A retrospective analysis from Peking University People's Hospital involving 199 elderly AML patients (≥50 years) who underwent allo-HSCT confirmed that haplo-HSCT is feasible in elderly AML patients; however, transplantation in a refractory\u002Factive disease state was associated with poorer transplant outcomes. A study from the EBMT summarized outcomes in 360 elderly patients (≥70 years) who underwent allogeneic transplantation in a non-remission state, reporting 2-year overall survival rates of 25.9%, 43%, and 62.4% for haplo-HSCT, unrelated donor, and matched sibling donor transplants, respectively.\n\nThe challenge in treating relapsed\u002Frefractory elderly AML patients lies in improving the tolerability of conditioning regimens and reducing conditioning-related toxicity, thereby increasing the success rate of transplantation. Venetoclax (VEN), an orally administered selective small-molecule B-cell lymphoma 2 (BCL-2) inhibitor, has demonstrated efficacy in randomized clinical trials across several hematologic malignancies. As monotherapy for relapsed\u002Frefractory AML, VEN shows modest efficacy while exhibiting good tolerability . In the global phase III clinical trial of venetoclax, in newly diagnosed AML patients unfit for intensive induction chemotherapy, venetoclax combined with azacitidine demonstrated significantly superior clinical efficacy compared to azacitidine alone, with a response rate (CR+CRi) more than three times higher than that of the control group, enabling patients to achieve faster and deeper remissions. Our center has also accumulated extensive experience with venetoclax in post-transplant maintenance therapy for AML and in the treatment of relapsed\u002Frefractory AML. Additionally, studies have confirmed the safety and efficacy of high-dose venetoclax in newly diagnosed AML . Based on the aforementioned clinical efficacy and theoretical rationale, our center previously conducted a study investigating the venetoclax + azacitidine + busulfan (VABu) regimen in allogeneic HSCT for elderly AML patients, confirming that this novel regimen reduces conditioning-related chemotherapy toxicity, improves tolerability, and demonstrates advantages in decreasing cardiotoxicity, mucositis, infections, and organ dysfunction. Lisaftolax, as a second-generation BCL-2 inhibitor, can partially overcome venetoclax resistance and improve patient outcomes.\n\nNevertheless, a consensus on the comprehensive systemic treatment strategy for elderly AML patients has not yet been reached globally. For high-risk or relapsed\u002Frefractory elderly AML patients, after risk stratification and assessment of response to chemotherapy, those who are suitable for allo-HSCT may receive a conditioning regimen consisting of cladribine bridged to lisaftolax and busulfan (Clad\u002FLABu), aiming to achieve longer remission duration, reduce post-transplant relapse rates, and improve long-term survival in elderly AML patients.",[206,28],"Relapsed or Refractory Acute Myeloid Leukemia (AML)",[208,209,210,211,212,213],"Conditioning Regimen","Relapsed or Refractory Acute Myeloid Leukemia","Cladribine","Lisaftolax","Busulfan","Allogeneic Hematopoietic Stem Cell Transplantation","2026-04-12",{"date":186,"type":38},{"date":217,"type":21},"2026-04-01",{"date":73,"type":21},{"name":220,"class":76},"The First Affiliated Hospital of Soochow University",{"id":222,"slug":223,"hasResults":11,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":227,"eligibilityCriteria":228,"healthyVolunteers":11,"sex":16,"minAge":85,"maxAge":229,"enrollmentInfo":230,"targetDuration":4,"studyType":22,"phases":232,"briefSummary":233,"conditions":234,"keywords":236,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":214,"lastUpdatePostDateStruct":241,"startDateStruct":242,"completionDateStruct":244,"leadSponsor":246,"locationsCount":99},"100623723","phase-2-romiplostim-versus-rhtpo-for-platelet-engraftment-after-transplant-in-mds-and-aa-100623723","NCT07400341","Romiplostim Versus rhTPO for Platelet Engraftment After Transplant in MDS and AA","A Randomized Phase II Study of Romiplostim vs. rhTPO for Platelet Engraftment After Allo-HSCT in Patients With MDS and Aplastic Anemia (PROMPT)","PROMPT","Inclusion Criteria:\n\n1. Age 18-65 years (inclusive).\n2. Diagnosis of Myelodysplastic Syndrome (MDS) per WHO criteria, or Severe\u002FVery Severe Aplastic Anemia (SAA\u002FVSAA) per Camitta criteria, and deemed eligible for allogeneic hematopoietic stem cell transplantation (allo-HSCT).\n3. Planned to receive allo-HSCT from a matched sibling, haploidentical, or unrelated donor (including cord blood).\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n5. Persistent platelet count \\\u003C20×10⁹\u002FL with platelet transfusion dependence between post-transplant days +4 and +10. Transfusion dependence is defined as platelet count not doubling within 24-48 hours after transfusion or ongoing need for prophylactic transfusion.\n6. Adequate cardiac, hepatic, and renal function as required for transplantation, per investigator assessment.\n7. Voluntary participation with written informed consent obtained prior to any study-specific procedures.\n\nExclusion Criteria:\n\n1. Active, uncontrolled bacterial, fungal, or viral infection at the time of enrollment.\n2. History of arterial thrombosis, or venous thromboembolism within the past 6 months (unless cured or stable for over 6 months).\n3. Active transplant-associated thrombotic microangiopathy (TA-TMA).\n4. Pre-transplant bone marrow biopsy showing fibrosis grade ≥ MF-2 (according to WHO criteria).\n5. Known hypersensitivity to Romiplostim, recombinant human thrombopoietin (rhTPO), or any of their excipients.\n6. Pregnant or lactating women.\n7. Women of childbearing potential or men with partners of childbearing potential who are unwilling to use highly effective contraception during the study period and for at least 3 months after the last dose of study drug.\n8. Any other condition that, in the opinion of the investigator, would make the patient unsuitable for participation in the study.","65 Years",{"count":231,"type":21},66,[24],"This study is for adults aged 18-65 with myelodysplastic syndrome (MDS) or severe aplastic anemia (AA) who are scheduled to receive a donor stem cell transplant (allogeneic hematopoietic stem cell transplant). After the transplant, it is critical for the body to start making its own blood cells again. A common and serious problem is a delay in the recovery of platelets (the cells that help stop bleeding), which increases the risk of bleeding, infection, and death.\n\nThis study aims to see if a new treatment can help platelets recover faster and more safely after transplant. We are comparing two drugs:\n\nRomiplostim: A long-acting injection given just once a week. rhTPO (Recombinant Human Thrombopoietin): A standard injection given every day. Both drugs are designed to help the body make more platelets. The main question is whether the once-weekly romiplostim works as well or better than the daily rhTPO, and if it is safe.\n\nAbout 66 patients will participate. By random chance (like flipping a coin), each participant will be assigned to receive either romiplostim or rhTPO. The treatment will start a few days after the transplant and continue until platelets recover to a safe level or for up to 8 weeks. Doctors will closely monitor all participants for 100 days to track platelet recovery, need for transfusions, side effects, and overall health.",[28,235],"Aplastic Anemia (AA)",[237,238,239,240],"Romiplostim","Recombinant Human Thrombopoietin (rhTPO)","Platelet Engraftment","Delayed Platelet Recovery",{"date":186,"type":38},{"date":243,"type":38},"2026-01-31",{"date":245,"type":21},"2028-12-31",{"name":220,"class":76},{"id":248,"slug":249,"hasResults":11,"nctId":250,"briefTitle":251,"officialTitle":251,"acronym":252,"eligibilityCriteria":253,"healthyVolunteers":11,"sex":16,"minAge":85,"maxAge":4,"enrollmentInfo":254,"targetDuration":256,"studyType":110,"phases":4,"briefSummary":257,"conditions":258,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":259,"lastUpdatePostDateStruct":260,"startDateStruct":262,"completionDateStruct":264,"leadSponsor":266,"locationsCount":99},"100632295","wearable-technology-for-collecting-health-data-in-people-who-are-the-transfused-watch-transfused---a-uk-exploratory-study-to-improve-quality-of-life-and-the-efficacy-of-transfusion-supportive-care-in-people-with-blood-cancers-undergoing-treatment-100632295","NCT07511829","WearAble Technology for Collecting Health Data in People Who Are the Transfused (WATCH Transfused) - A UK Exploratory Study to Improve Quality of Life and the Efficacy of Transfusion Supportive Care in People With Blood Cancers Undergoing Treatment","WATCH Tranfuse","Inclusion Criteria:\n\n* Patients aged ≥18 years with WHO-defined MDS or mixed myeloproliferative\u002Fmyelodysplastic neoplasm overlap syndromes (MPN\u002FMDS), myeloma and AML\n* Intention to undertake disease modifying treatment\n* Life expectancy ≥ 6 months\n* Able to complete quality of life questionnaires\n* Willing and able to provide informed consent for participation in the study\n* Willing to receive blood products as part of normal NHS care\n\nExclusion Criteria:\n\n* Poor performance\u002Ffunctional status (Eastern Cooperative Oncology Group system ECOG ≥3)\n* Participants with known arrhythmias or other significant cardiological conductivity disorders\n* Patients with severe comorbidities\n* Patients with known skin allergies or conditions that in the opinion of the investigator would compromise the safety of the patient or quality of the data\n* Hospitalised patients\n* Patients currently participating in another interventional clinical study\n* Patients with a pacemaker or implanted cardioverter defibrillator or any cardiac implanted device",{"count":255,"type":21},80,"2 Months","Cancer treatments such as chemotherapy often affect healthy cells as well as the cancer cells and this can lead to side-effects such as low blood counts - anaemia. This can cause severe fatigue, shortness of breath and brain fog and may need regular blood transfusions. Their quality of life (QoL) is often very poor during treatment because of these side effects, and it is hard to deal with.\n\nDoctors use blood tests to decide whether a patient is well enough for treatment and when to start treatment. However, blood tests do not tell us how a person feels, and it is not the same in everyone. We need a better way for doctors to monitor patients' QoL and these symptoms so that they are physically and emotionally able to continue their treatment. It is hard for doctors to accurately assess this through speaking to their patients and doctors do not record or discuss these effects of treatment very well with patients.\n\nThe aim of this study is to better understand how people feel during their treatment and how we can best use blood transfusions to maintain QoL.\n\n80 adult patients who are starting blood cancer treatments will be asked to answer questionnaires about how they are feeling and their symptoms during their treatment. Participants will be asked to wear a smartwatch to measure their physical activity levels. Activity data collected will then be compared with their reported QoL and blood counts to help us understand when patients can tolerate difficult treatments the best and how blood transfusions affect this.\n\nPatients, their family and carers will be invited to take part in an interview to understand their views on how we can improve their care, QoL and access to transfusions.\n\nA better understanding of the impact of low blood counts on QoL can help us use blood transfusions to benefit patients' lives. This work will better match transfusions to individual peoples' needs and therefore 'personalise' blood transfusion care.",[28,62],"2026-03-30",{"date":261,"type":38},"2026-04-06",{"date":263,"type":38},"2026-02-17",{"date":265,"type":21},"2027-09-01",{"name":267,"class":76},"University of Oxford",{"id":269,"slug":270,"hasResults":11,"nctId":271,"briefTitle":272,"officialTitle":273,"acronym":274,"eligibilityCriteria":275,"healthyVolunteers":276,"sex":16,"minAge":85,"maxAge":4,"enrollmentInfo":277,"targetDuration":4,"studyType":22,"phases":279,"briefSummary":280,"conditions":281,"keywords":282,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":287,"lastUpdatePostDateStruct":288,"startDateStruct":290,"completionDateStruct":292,"leadSponsor":294,"locationsCount":296},"100600346","phase-2-luspatercept--darbepoetin-in-mds-100600346","NCT07096297","Luspatercept + Darbepoetin in MDS","A Phase II Study of Luspatercept Plus Darbepoetin Alfa in Non-mutated SF3B1 Lower-risk Myelodysplastic Syndromes","DarbeLus","Inclusion Criteria:\n\n1. Ability to understand and the willingness to sign a written informed consent document.\n2. Participant is 18 years or older at the time of signing informed consent.\n3. Participant has lower-risk myelodysplastic syndrome (MDS) defined as very low, low and intermediate risk by International Prognostic Scoring System-Revised (IPSS-R) criteria (3).\n4. Bone marrow biopsy within 90 days of screening demonstrated less than 5% blasts in the aspirate and\u002For core biopsy. If no bone marrow biopsy was done within 90 days of screening it is mandatory to repeat it at screening. Otherwise, bone marrow biopsy is optional at screening to obtain correlative study samples.\n5. Absence of SF3B1 mutation and del5q.\n6. Endogenous serum erythropoietin alfa (EPO) level \\\u003C 500 IU\u002FL.\n7. Participant is transfusion dependent defined as ≥ 2 packed red blood cell (PRBC) units\u002F8 weeks for a minimum of eight weeks immediately prior to screening. The maximum consecutive timeframe participants may be RBC transfusion-free within this 8-week time period is six weeks.\n\n   a. Red blood cell transfusions administered when hemoglobin levels were \\> 9.0 g\u002FdL and\u002For RBC transfusions administered for elective surgery, infections or bleeding events will not be counted in above.\n8. Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-3 (Appendix 1. ECOG Performance Status Scale).\n9. Participant has adequate organ function defined as:\n\n   1. Serum aspartate aminotransferase\u002Fserum glutamic oxaloacetic transaminase (AST\u002FSGOT) and alanine aminotransferase (ALT\u002FSGPT) ≤ 3 x ULN, unless considered due to organ involvement by the participant's myeloid malignancy (in that case a cut off ≤ 5 x ULN will be used).\n   2. Serum direct bilirubin \\\u003C 1.5 x ULN.\n   3. Creatinine clearance \\> 30 mL\u002Fmin based on the Cockroft-Gault glomerular filtration rate (GFR) estimation.\n10. Participants must adhere to the following reproductive and contraceptive requirements while on study treatment and for three months after the last dose of luspatercept and darbepoetin alfa:\n\n    a. General Requirements: i. Participants must not be pregnant or breastfeeding. ii. Participants must not donate gametes (i.e., eggs or sperm) or freeze gametes for future use related to assisted reproduction.\n\n    b. For participants of childbearing potential: i. Participant of childbearing potential is defined as an individual who is premenopausal and capable of becoming pregnant, including those using contraception, those who are single, or those with partners who have had a vasectomy.\n\nii. A negative highly sensitive pregnancy test must be obtained at screening, and a negative serum or urine pregnancy test must be obtained within 72 hours starting on treatment, and participants must agree to further pregnancy tests throughout the study as required per the site's institutional guidelines.\n\niii. Participants must agree to use two methods of contraception of which one must be highly effective for three months after the last dose of luspatercept and darbepoetin alfa.\n\nc. For Partners of Participants: i. If the participant's partner is of childbearing potential, the partner must also practice a highly effective method of contraception while the participant is on study treatment and for three months after the last dose of luspatercept and darbepoetin alfa, unless the participant is vasectomized.\n\nd. Highly effective methods of contraception include, but are not limited to: i. Combined hormonal contraception (estrogen and progestogen) that inhibits ovulation (oral, intravaginal, or transdermal).\n\nii. Progestogen-only hormonal contraception that inhibits ovulation (oral, injectable, or implantable).\n\niii. Non-hormonal (cooper) intrauterine device (IUD). iv. Intrauterine hormone-releasing system. v. Bilateral tubal occlusion. vi. Sexual abstinence (the reliability of abstinence must be evaluated concerning the duration of the clinical study and the participant's lifestyle).\n\nvii. A vasectomized partner (provided the partner is the sole sexual partner of the study participant of childbearing potential and that the vasectomized partner has received medical confirmation of the surgical success).\n\nExclusion Criteria:\n\n1. Prior treatment with ESA, luspatercept, hypomethylating agents or lenalidomide\u002Fthalidomide\u002Fother immunomodulating drug (IMiDs).\n\n   1. Exception 1: Participants can have received ≤ 2 doses of prior epoetin alfa or ≤ 1 dose darbepoetin alfa if ≥ 8 weeks from date of consent.\n   2. Exception 2: Participants can have received ≤ 1 week of treatment with lenalidomide ≥ 8 weeks from the date of consent, at the sponsor-investigator's discretion.\n   3. After signing consent, the participants are not allowed to receive any of these drugs: other RBC hematopoietic growth factors (e.g., Interleukin-3), granulocyte colony stimulating factors (i.e., G-CSF, GM-CSF), except in cases of neutropenic fever, cytotoxic, chemotherapeutic, targeted or investigational agents\u002Ftherapies, azacitidine, decitabine or other hypomethylating agents, lenalidomide, thalidomide and other immunomodulating drugs (IMiDs), hydroxyurea, androgens, unless to treat hypogonadism, oral retinoids (topical retinoids are permitted), arsenic trioxide, interferon and interleukins.\n2. Participants with history of seizures at any time.\n3. Participants with any of the following conditions within six months prior to screening:\n\n   1. Stroke.\n   2. Thrombosis\u002Fthromboembolism.\n   3. Myocardial infarction.\n   4. Uncontrolled angina.\n   5. Acute decompensated cardiac failure or New York Heart Association (NYHA) Class III-IV heart failure.\n   6. Uncontrolled cardiac arrhythmia as determined by the investigator.\n4. Participant has immediate life-threatening, severe complications of their myeloid malignancy such as uncontrolled bleeding, pneumonia with hypoxia or shock, and\u002For disseminated intravascular coagulation.\n5. Participants with uncontrolled hypertension defined as systolic blood pressure (SBP) of ≥ 150 mmHg and\u002For diastolic blood pressure (DBP) ≥ 100 mmHg despite adequate treatment. Participant with history of cerebrovascular accident (including ischemic, embolic, and hemorrhagic cerebrovascular accident), transient ischemic attack.\n6. Participant has active viral infection with human immunodeficiency virus (HIV), or active infection with hepatitis B virus (HBV) or active infection with hepatitis C virus (HCV). Participants with HIV that is controlled (not detectable viral load) with highly active antiretroviral therapy (HAART) are eligible to participate.\n7. Participant has active uncontrolled systemic fungal, bacterial, or viral infection (defined as ongoing signs\u002Fsymptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and\u002For other treatment).\n8. Participant who is pregnant or lactating.\n\n   1. Pregnant participants are excluded from this study because luspatercept has shown in animal studies to be potentially associated with fetal harm.\n   2. Because there is an unknown but potential risk for AE in nursing infants secondary to treatment, lactating participants are excluded from this study.\n9. Participant with prior history of malignancies, other than MDS, unless the participant has been free of the disease for ≥ 5 years. However, participants with the following history\u002Fconcurrent conditions are allowed:\n\n   1. Basal or squamous cell carcinoma of the skin.\n   2. Carcinoma in situ of the cervix.\n   3. Carcinoma in situ of the breast.\n   4. Incidental histologic finding of prostate cancer (T1a or T1b using the tumor, nodes, metastasis TNM clinical staging system).",true,{"count":278,"type":21},60,[24],"This is a single arm open-label Phase II trial of luspatercept and darbepoetin alfa in non-mutated SF3B1 , lower-risk, RBC transfusion dependent MDS participants with an endogenous erythropoietin (EPO) level \\\u003C 500 IU\u002FL.",[28],[283,284,285,286],"SF3B1 wild type","RBC transfusion dependent","lower risk","non-mutated SF3B1","2026-03-20",{"date":289,"type":38},"2026-03-23",{"date":291,"type":38},"2025-12-16",{"date":293,"type":21},"2030-08",{"name":295,"class":76},"Yale University",3,{"id":298,"slug":299,"hasResults":11,"nctId":300,"briefTitle":301,"officialTitle":301,"acronym":302,"eligibilityCriteria":303,"healthyVolunteers":11,"sex":16,"minAge":85,"maxAge":304,"enrollmentInfo":305,"targetDuration":4,"studyType":22,"phases":307,"briefSummary":308,"conditions":309,"keywords":319,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":322,"lastUpdatePostDateStruct":323,"startDateStruct":325,"completionDateStruct":327,"leadSponsor":329,"locationsCount":332},"100582139","phase-2-a-platform-protocol-to-investigate-post-transplant-cyclophosphamide-based-graft-versus-host-disease-prophylaxis-in-patients-with-hematologic-malignancies-undergoing-mismatched-unrelated-donor-peripheral-blood-stem-cell-transplantation-100582139","NCT06859424","A Platform Protocol to Investigate Post-Transplant Cyclophosphamide-Based Graft-Versus-Host Disease Prophylaxis in Patients With Hematologic Malignancies Undergoing Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation","ACCELERATE","Inclusion Criteria, MAC RECIPIENTS:\n\n1. Age 18 to \\\u003C 66 years (chemotherapy-based conditioning) or \\\u003C 61 years (TBI-based conditioning) at the time of signing informed consent\n2. Patient or legally authorized representative has the ability to provide informed consent according to the applicable regulatory and institutional requirements\n3. Stated willingness to comply with all study procedures and availability for the duration of the study\n4. Planned MAC regimen (see Table 8 in Section 7.4 for allowed MAC regimens)\n5. Available partially HLA-MMUD (4\u002F8-7\u002F8 at HLA-A, -B, -C, and -DRB1 is required) with age 16-35\n6. Product planned for infusion is MMUD T-cell replete PBSC as allograft\n7. HCT-CI \\\u003C 5 (Appendix H - Hematopoietic Cell Transplant Comorbidity Index Scoring). The presence of prior malignancy will not be used to calculate HCT-CI for this trial, to allow for the inclusion of patients with secondary or therapy-related AML or MDS.\n8. One of the following diagnoses:\n\n   1. AML, ALL, or other acute leukemia in first remission or beyond with ≤ 5% marrow blasts and no circulating blasts or evidence of extramedullary disease. Documentation of bone marrow assessment will be accepted within 45 days prior to the anticipated start of conditioning.\n   2. Patients with MDS with no circulating blasts and with \\\u003C 10% blasts in the bone marrow (higher blast percentage allowed in MDS due to lack of differences in outcomes with \\\u003C 5% vs 5-10% blasts in MDS). Documentation of bone marrow assessment will be accepted within 45 days prior to the anticipated start of conditioning.\n9. Cardiac function: Left ventricular ejection fraction ≥ 45% based on most recent echocardiogram or multi-gated acquisition scan (MUGA) results\n10. Estimated creatinine clearance ≥ 45mL\u002Fmin calculated by equation\n11. Pulmonary function: diffusing capacity of the lungs for carbon monoxide (DLCO) corrected for hemoglobin ≥ 50% and forced expiratory volume in first second (FEV1) predicted ≥ 50% based on most recent PFT results\n12. Liver function acceptable per local institutional guidelines\n13. KPS of ≥ 70% (Appendix I - Performance Status)\n\nInclusion Criteria, RIC\u002FNMA RECIPIENTS:\n\n1. Age ≥ 18 years at the time of signing informed consent\n2. Patient or legally authorized representative has the ability to provide informed consent according to the applicable regulatory and local institutional requirements\n3. Stated willingness to comply with all study procedures and availability for the duration of the study\n4. Planned NMA\u002FRIC regimen (see\n5. Table 9 in Section 7.4 for allowed NMA\u002FRIC regimens)\n6. Available partially HLA-MMUD (4\u002F8-7\u002F8 at HLA-A, -B, -C, and -DRB1 is required) with age 16-35\n7. Product planned for infusion is MMUD T-cell replete PBSC allograft\n8. One of the following diagnoses:\n\n   1. Patients with acute leukemia or chronic myeloid leukemia (CML) with no circulating blasts, no evidence of extramedullary disease, and with \\\u003C 5% blasts in the bone marrow. Documentation of bone marrow assessment will be accepted within 45 days prior to the anticipated start of conditioning.\n   2. Patients with MDS with no circulating blasts and with \\\u003C 10% blasts in the bone marrow (higher blast percentage allowed in MDS due to lack of differences in outcomes with \\\u003C 5% vs 5-10% blasts in MDS.) Documentation of bone marrow assessment will be accepted within 45 days prior to the anticipated start of conditioning.\n   3. Patients with chronic lymphocytic leukemia (CLL) or other leukemias (including prolymphocytic leukemia) with chemosensitive disease at time of transplantation.\n   4. Higher-risk chronic myelomonocytic leukemia (CMML) according to CMML-specific prognostic scoring system or high-risk MDS\u002Fmyeloproliferative neoplasms (MPN) not otherwise specified are eligible, provided there is no evidence of high-grade bone marrow fibrosis or massive splenomegaly at the time of enrollment.\n   5. Patients with lymphoma with chemosensitive disease at the time of transplantation.\n   6. Patients with primary myelofibrosis or myelofibrosis secondary to essential thrombocythemia, polycythemia vera or MDS with grade 4 fibrosis.\n9. Cardiac function: Left ventricular ejection fraction ≥ 40% based on most recent echocardiogram or MUGA results with no clinical evidence of heart failure\n10. Estimated creatinine clearance ≥ 45mL\u002Fmin calculated by equation\n11. Pulmonary function: DLCO corrected for hemoglobin ≥ 50% and FEV1 predicted ≥ 50% based on most recent PFT results\n12. Liver function acceptable per local institutional guidelines\n13. KPS of ≥ 60% (Appendix I - Performance Status)\n\nExclusion Criteria:\n\n1. Suitable HLA-matched related or 8\u002F8 high-resolution matched unrelated donor available\n2. Subject unwilling or unable to give informed consent, or unable to comply with the protocol including required follow-up and testing\n3. Subjects with a prior allogeneic transplant\n4. Subjects with an autologous transplant within the past 3 months\n5. Subjects who are breastfeeding or pregnant\n6. Uncontrolled bacterial, viral or fungal infection at the time of the transplant preparative regimen\n7. Concurrent enrollment on a GVHD prevention clinical trial\n8. Subjects who undergo desensitization to reduce anti-donor HLA antibody levels prior to transplant\n9. Patients who are HIV-positive with persistently positive viral load. HIV-infected patients on effective anti-retroviral therapy (ART) with undetectable viral load within 6 months are eligible for this trial. Patients with well-controlled HIV are eligible provided resistance panels are negative, the patient is compliant with ART, and their disease remains well controlled.","66 Years",{"count":306,"type":21},358,[24],"The purpose of this clinical trial is to compare drug combinations to learn which drugs work best to prevent graft-versus-host-disease (GVHD) in people who have received a stem cell transplant. The source of stem cells is from someone who is not related and has a different blood cell type than the study participant. The researchers will compare the new drug combination to a standard drug combination. They will also learn about the safety of each drug combination.\n\nParticipants will:\n\n* Receive the standard or new drug combination after transplant\n* Visit the doctor's office for check-ups and tests after transplant that are routine for most transplant patients\n* Take surveys about physical and emotional well-being\n* Give blood and stool samples.",[113,310,311,28,312,313,314,315,316,317,318],"Acute Lymphoid Leukemia (ALL)","Acute Leukemia (Category)","CML (Chronic Myelogenous Leukemia)","CLL (Chronic Lymphocytic Leukemia)","Prolymphocyctic Leukemia","Chronic Myelomonocytic Leukemia (CMML)","Myeloproliferative Neoplasm (MPN)","Lymphoma","Myelofibrosis",[302,320,321],"ACCEL-001","ACCEL-002","2026-03-16",{"date":324,"type":38},"2026-03-17",{"date":326,"type":38},"2025-07-25",{"date":328,"type":21},"2028-06",{"name":330,"class":331},"Center for International Blood and Marrow Transplant Research","NETWORK",13,{"id":334,"slug":335,"hasResults":11,"nctId":336,"briefTitle":337,"officialTitle":337,"acronym":4,"eligibilityCriteria":338,"healthyVolunteers":11,"sex":16,"minAge":85,"maxAge":339,"enrollmentInfo":340,"targetDuration":4,"studyType":22,"phases":342,"briefSummary":343,"conditions":344,"keywords":354,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":363,"lastUpdatePostDateStruct":364,"startDateStruct":366,"completionDateStruct":368,"leadSponsor":370,"locationsCount":372},"100484580","phase-1-a-first-in-human-study-of-hla-partially-to-fully-matched-allogenic-cryopreserved-deceased-donor-bone-marrow-transplantation-for-patients-with-hematologic-malignancies-100484580","NCT05589896","A First-in-Human Study of HLA-Partially to Fully Matched Allogenic Cryopreserved Deceased Donor Bone Marrow Transplantation for Patients With Hematologic Malignancies","Inclusion Criteria:\n\n* Patient has the ability to provide informed consent according to the applicable regulatory and local institutional requirements\n* Male or female, aged ≥18 and ≤65 years for patients receiving MAC (Regimen A or Regimen B); aged ≥18 and ≤75 years for patients receiving RIC (Regimen C or D)\n* Patient must require allogeneic HCT per the discretion of the treating physician\n* Patient must be high-resolution, HLA partially or fully matched (4-8\u002F8 allele matched at HLA-A, -B, -C, DRB1) to an available Ossium HPC, Marrow product\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Diagnosed with malignant hematologic disease including:\n\n  1. Acute leukemia \\[acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML), acute biophenotypic leukemia (ABL), or acute undifferentiated leukemia (AUL)\\], MDS without fibrosis, or chronic leukemia (CLL, CML) in the first remission or beyond with ≤5% marrow blasts documented by bone marrow assessment and no circulating blasts or extra-medullary disease within 42 days prior to anticipated start of conditioning\n  2. Chemosensitive non-Hodgkin's lymphomas, Hodgkin's lymphoma, or cutaneous T cell lymphomas in the first remission or beyond documented by PET\u002FCT imaging and bone marrow assessment within 42 days prior to anticipated start of conditioning\n* Karnofsky performance status score ≥70% (MAC) or ≥60% (RIC)\n* HCT comorbidity index (HCT-CI) ≤5\n* Adequate organ function defined as:\n\n  1. Cardiac: LVEF at rest ≥40% (RIC) or LVEF at rest ≥45% (MAC)\n  2. Pulmonary: DLCO, FEV1, FVC ≥50% predicted by pulmonary function tests (PFTs). DLCO value may be corrected for hemoglobin.\n  3. Hepatic: total bilirubin ≤2.0 mg\u002FdL, and ALT, AST, and ALP \\\u003C3 x upper limit normal (ULN), unless ALT, AST, and\u002For ALP are disease related\n  4. Renal: SCr within 1.5x normal range for age. If SCr is outside normal range for age, CrCl\\> 60 mL\u002Fmin\u002F1.73m2 must be obtained (measured by 24-hour urine specimen or nuclear glomerular filtration rate (GFR), or calculated GFR)\n\nExclusion Criteria:\n\n* Availability of suitable graft from living donor (defined as 7\u002F8 or 8\u002F8 HLA-matched related or unrelated donors, haploidentical donors, or cord blood donors)\n* Prior autologous or allogeneic HCT\n* Pregnancy or lactation\n* Ongoing treatment with an investigational drug used for disease-related treatment within 5 half-lives of the drug\n* Current uncontrolled bacterial, viral or fungal infection defined as currently taking medication with evidence of progression of clinical symptoms or radiologic findings\n* Any condition(s) or diagnosis, both physical or psychological, or physical exam finding that in the investigator's opinion precludes participation","75 Years",{"count":341,"type":21},12,[162,24],"The goal of this clinical trial is to determine the safety and feasibility of allogeneic transplantation with bone marrow from a deceased donor in patients with acute and chronic leukemias, myelodysplastic syndrome, and certain lymphomas. Patients will either receive myeloablative conditioning or reduced intensity conditioning regimen prior to the transplant. Patients will be followed for 56 days for safety endpoints and remain in follow-up for one year.",[345,346,347,348,349,313,350,28,351,352,353],"Acute Leukemia","Acute Lymphoblastic Leukemia","Acute Myeloid Leukemia","Acute Biphenotypic Leukemia","Acute Undifferentiated Leukemia","Chronic Myeloid Leukemia (CML)","Non-Hodgkin Lymphomas","Hodgkins Lymphoma","Cutaneous T Cell Lymphomas (CTCL)",[165,355,16,356,357,358,359,317,360,361,362],"Hematologic Diseases","AML","ABL","AUL","Bone Marrow Transplant","MDS","CLL","CML","2026-02-20",{"date":365,"type":38},"2026-02-24",{"date":367,"type":38},"2024-08-16",{"date":369,"type":21},"2027-03-31",{"name":371,"class":126},"Ossium Health, Inc.",9,{"id":374,"slug":375,"hasResults":11,"nctId":376,"briefTitle":377,"officialTitle":378,"acronym":4,"eligibilityCriteria":379,"healthyVolunteers":11,"sex":16,"minAge":85,"maxAge":4,"enrollmentInfo":380,"targetDuration":4,"studyType":22,"phases":382,"briefSummary":383,"conditions":384,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":387,"lastUpdatePostDateStruct":388,"startDateStruct":390,"completionDateStruct":392,"leadSponsor":394,"locationsCount":99},"100617669","phase-1-romiplostim-n01-for-platelet-recovery-after-haploidentical-hsct-100617669","NCT07321626","Romiplostim N01 for Platelet Recovery After Haploidentical HSCT","Efficacy and Safety of Romiplostim N01 in Promoting Platelet Reconstruction After Haploidentical Allogeneic Stem Cell Transplantation in Patients With Hematologic Malignancies","Inclusion Criteria:\n\nPatients with malignant hematologic diseases scheduled to undergo haploidentical allogeneic hematopoietic stem cell transplantation (haplo-HSCT) Age ≥18 years, male or female. ECOG performance status 0-1. Estimated life expectancy \\>6 months. Adequate renal function, defined as:serum creatinine ≤1.5 × upper limit of normal (ULN);Blood urea nitrogen (BUN) ≤1.5 × ULN.\n\nAdequate hepatic function, defined as:Alanine aminotransferase (ALT) ≤2 × ULN.Aspartate aminotransferase (AST) ≤2 × ULN.Total bilirubin ≤1.5 × ULN.\n\nAbility to understand and sign informed consent, and willingness to comply with all study requirements.\n\nExclusion Criteria:\n\nUncontrolled active infection or other active malignancy that could interfere with study participation.\n\nSevere cardiovascular disease, including:New York Heart Association (NYHA) Class III-IV heart failure;Uncontrolled hypertension or hypotension;History of or high risk for thromboembolic events.\n\nReceiving anticoagulation therapy for thrombotic events. Known hypersensitivity to romiplostim or similar agents. Use of rh-TPO or any thrombopoietin receptor agonist (TPO-RA) within 30 days prior to enrollment.\n\nParticipation in another interventional clinical study within 30 days prior to enrollment.\n\nAny other condition that, in the investigator's judgment, makes the patient unsuitable for the study.",{"count":381,"type":21},130,[162],"This is a prospective, randomized, controlled clinical study designed to evaluate the efficacy and safety of Romiplostim N01 in promoting platelet engraftment after haploidentical allogeneic hematopoietic stem cell transplantation (haplo-HSCT) in patients with hematologic malignancies.\n\nA total of 130 patients who undergo haplo-HSCT for acute myeloid leukemia (AML), myelodysplastic syndromes (MDS), or other hematologic malignancies will be enrolled and randomized 1:1 into a treatment group and a control group. The treatment group will receive Romiplostim N01 subcutaneously once weekly at a starting dose of 5 µg\u002Fkg, with dose adjustments based on platelet counts (maximum 10 µg\u002Fkg), for up to 4 weeks or until platelet counts reach ≥100 × 10⁹\u002FL. The control group will not receive rh-TPO or any thrombopoietin receptor agonist (TPO-RA) therapy. Supportive care including transfusions and growth factors (G-CSF, ESA) is allowed in both groups.\n\nThe primary endpoint is the cumulative platelet engraftment rate by day +21 post-transplant, defined as sustained platelet counts \\> 20 × 10⁹\u002FL for at least 7 consecutive days without transfusion. Secondary endpoints include median time to platelet engraftment, median time to achieve platelet counts ≥ 50 × 10⁹\u002FL and ≥ 100 × 10⁹\u002FL, total platelet transfusion volume, erythroid and neutrophil responses within 4 weeks, and overall hematopoietic recovery. Safety endpoints include the incidence of adverse events, thromboembolic events, and treatment-related serious adverse events.\n\nThe study aims to determine whether early administration of Romiplostim N01 can accelerate platelet recovery and reduce bleeding risk in patients undergoing haplo-HSCT, thereby improving post-transplant outcomes.",[347,28,385,386],"Delayed Platelet Engraftment","HSCT","2026-01-26",{"date":389,"type":38},"2026-01-28",{"date":391,"type":38},"2025-06-01",{"date":393,"type":21},"2027-12",{"name":395,"class":76},"First Affiliated Hospital of Zhejiang University",{"id":397,"slug":398,"hasResults":11,"nctId":399,"briefTitle":400,"officialTitle":401,"acronym":4,"eligibilityCriteria":402,"healthyVolunteers":11,"sex":16,"minAge":85,"maxAge":339,"enrollmentInfo":403,"targetDuration":4,"studyType":22,"phases":405,"briefSummary":406,"conditions":407,"keywords":408,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":411,"lastUpdatePostDateStruct":412,"startDateStruct":414,"completionDateStruct":416,"leadSponsor":417,"locationsCount":296},"100619634","phase-1-a-phase-1-study-of-cg009301-for-injection-in-adult-subjects-with-recurrent-or-refractory-haematological-malignancies-100619634","NCT07347171","A Phase 1 Study of CG009301 for Injection in Adult Subjects With Recurrent or Refractory Haematological Malignancies","A Phase 1, Open-label, Multicentre Study Evaluating the Safety, Tolerability, Pharmacokinetic\u002FPharmacodynamic Characteristics, and Preliminary Efficacy of CG009301 for Injection in Adult Subjects With Relapsed or Refractory Haematological Malignancies","Inclusion Criteria:\n\n1. Age ≥18 years and \\\u003C75 years at the time of signing the informed consent form; no gender restrictions;\n2. Patients with relapsed\u002Frefractory haematological malignancies who have received a definitive diagnosis by pathology and\u002For cytology, confirmed histologically, and who have failed prior standard treatment regimens. The investigator must deem that no standard treatment is available or that the patient cannot tolerate existing therapies. Dose-escalation phase: unrestricted haematological tumour types. Dose-expansion phase: must meet one of the following criteria: a. Subjects meeting AML diagnostic criteria based on WHO 2022 5th edition classification, confirmed by bone marrow cytomorphology, including AML evolving from early-stage MDS or MPN. Criteria for recurrent AML: Leukaemic cells reappearing in peripheral blood after CR, or \\>5% blast\u002Fimmature cells in bone marrow, or extramedullary leukaemic infiltration. Criteria for refractory AML: - Treatment-naïve cases unresponsive to two standard-regimen cycles; - Relapse within 12 months after consolidation\u002Fintensification therapy following CR; - Relapse after 12 months unresponsive to conventional chemotherapy; Patients with two or more relapses; Persistent extramedullary leukaemia; b. Patients diagnosed with high-risk or very high-risk MDS according to the WHO 2022 5th edition classification, with a percentage of blasts in bone marrow smear or biopsy pathology \\\u003C 20%, and deemed by the investigator to have no other appropriate treatment options. Diagnostic criteria for recurrent MDS: Following achievement of complete remission, partial remission, or haematological improvement, at least one of the following must occur: - Bone marrow blastic count returns to pre-treatment levels; - ANC or PLT decreases by ≥50% from best response; - HGB decreases by ≥15 g\u002FL or becomes transfusion-dependent. Diagnostic criteria for refractory MDS: Following adequate treatment (at least four cycles of demethylating agent therapy), meeting the IWG 2023 response criteria for \"stable disease\", \"failure\", or \"disease progression\"; progression after demethylating agent or other drug therapy, or patient intolerance to toxicity (e.g., treatment-related grade 3 or higher hepatic or renal toxicity during therapy leading to permanent discontinuation); c. Subjects meeting ALL diagnostic criteria based on WHO 2022 5th edition classification, with ≥20% primitive\u002Fimmature lymphocytes in bone marrow. Relapsed ALL diagnostic criteria: Patients who, after achieving CR following induction therapy, exhibit recurrence of leukaemic cells in peripheral blood, \\>5% primitive\u002Fimmature lymphocytes in bone marrow, or development of extramedullary disease; Criteria for refractory ALL: Patients failing to achieve CR following standard induction therapy;\n3. ECOG performance status score of 0-1;\n4. Investigator-assessed expected survival ≥3 months;\n5. Recovery of toxicities from prior treatment to ≤Grade 1 according to NCI-CTCAE v5.0 (excluding alopecia and long-term stable chronic conditions);\n6. No prior autologous haematopoietic stem cell transplantation, or transplantation more than 2 months prior with toxicities resolved to ≤ Grade 1;\n7. Adequate organ function support, with screening laboratory tests meeting all criteria: a. Coagulation function prior to study drug administration: INR ≤ 1.5 × ULN or aPTT ≤ 1.5 × ULN; b. Hepatic function: serum total bilirubin ≤ 2× ULN; AST and\u002For ALT ≤ 2.5× ULN; c. Cr ≤ 2× ULN or CrCL \\> 30 mL\u002Fmin (calculated using Cockcroft-Gault formula); d. LVEF ≥ 40%; and QTc ≤ 480 milliseconds; e. White blood cell count may decrease below 50.0 × 10⁹\u002FL at baseline or following hydroxyurea administration\n8. Non-pregnant and non-lactating: Infertile subjects; or subjects with potential for conception who agree to use effective contraception (hormonal, barrier, or abstinence). Male subjects must also abstain from sperm donation during study participation and for 90 days after the last dose of CG009301 injection. Women of childbearing potential must have a negative serum pregnancy test (serum-β-hCG) during the screening period;\n9. Understand the study's purpose, process, nature, significance, potential benefits, and risks, and voluntarily sign the written informed consent form. Be able to comply with scheduled visits, treatment plans, laboratory tests, and other study instructions or procedures.\n\nExclusion Criteria:\n\n1. Central nervous system leukaemia presenting with neurological and\u002For psychiatric symptoms;\n2. Receipt of antitumour therapy (excluding hydroxyurea and prophylactic intrathecal injections) such as chemotherapy, immunotherapy, targeted therapy, or biological therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to the first study drug administration; receipt of radiotherapy within 2 weeks; receipt of traditional Chinese herbal medicine within 2 weeks;\n3. Major surgery within 4 weeks prior to the first study dose, or anticipated need for major surgery during the study period;\n4. Active infection deemed uncontrolled by the investigator following treatment with antibiotics, antiviral agents, or antifungal medications;\n5. Severe or uncontrolled underlying medical conditions deemed ineligible for inclusion by the investigator, including but not limited to respiratory disorders (e.g., chronic obstructive pulmonary disease requiring oxygen therapy, moderate or higher asthma, moderate or higher pulmonary fibrosis, recurrent pulmonary oedema), cardiovascular disorders (e.g., prior coronary artery bypass grafting or coronary stent implantation, myocardial infarction within the past 6 months, NYHA Class III-IV heart failure), unstable angina within the past 6 months, uncontrolled hypertension (systolic \\>160 mmHg or diastolic \\>100 mmHg), arrhythmias requiring ongoing medical or interventional management), endocrine disorders (severe hyperthyroidism\u002Fhypothyroidism, uncontrolled diabetes mellitus), and neurological\u002Fpsychiatric conditions affecting cognition, compliance, or personal safety (e.g., unstable epilepsy, dementia, schizophrenia, depression); psychiatric disorders (e.g., unstable epilepsy, dementia, schizophrenia, depression);\n6. Active autoimmune diseases (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune haemolytic anaemia, scleroderma, severe psoriasis, rheumatoid arthritis), or allergy to the study drug or excipients;\n7. Significant non-leukaemia-related bleeding risk (e.g., anticoagulant or antiplatelet therapy, arteriovenous malformation), or recent history of major bleeding (e.g., gastrointestinal haemorrhage, intracranial haemorrhage, disseminated intravascular coagulation);\n8. Grade 2 or higher central nervous system or peripheral neuropathy (excluding stable Grade 3 conditions lasting over 6 months that do not impair daily functioning);\n9. Allogeneic haematopoietic stem cell transplantation within 12 months prior to initial administration;\n10. History of deep vein thrombosis, pulmonary embolism, or any other severe thromboembolic event within 6 months prior to initial administration (thrombosis originating from implanted venous access ports or catheters, superficial vein thrombosis, or lacunar cerebral infarction are not considered \"severe\" thromboembolic events); Known familial and\u002For acquired thrombotic predisposition, such as hereditary or acquired defects in anticoagulant proteins, coagulation factors, fibrinolytic proteins, or presence of acquired risk factors conferring high thrombotic propensity;\n11. HIV, HBV, and HCV infection: positive HIV antibody and PCR tests; HBsAg positive or viral DNA ≥100 IU\u002FmL; positive HCV antibody with HCV-RNA quantification exceeding the upper limit of normal;\n12. Individuals who received (attenuated) live virus vaccination within 4 weeks prior to first dosing;\n13. Individuals with a documented history of alcohol or substance abuse;\n14. Any past or current medical condition, treatment, or laboratory abnormality that may interfere with study results or affect the subject's ability to complete the study, or if the investigator deems the subject unsuitable for participation in this study.",{"count":404,"type":21},45,[162],"The goal of this clinical trial is to learn about the safety of drug CG009301. It also learns if drug CG009301 works to treat in Participants with relapsed or refractory adult haematological malignancies.\n\nThe main question\\[s\\] it aims to answer are:\n\n1. To determine the maximum tolerated dose (MTD) and\u002For objective best dose (OBD) of CG009301 for injection in subjects with relapsed or refractory adult haematological malignancies.\n2. To establish subsequent dosing regimens for CG009301 for injection.\n3. To characterise the safety profile and tolerability of CG009301 for injection. Participants will Receive treatment with CG009301 until disease progression.",[165,356,360,113,28],[165,409,410,356,360],"GSPT1","CG009301","2026-01-08",{"date":413,"type":38},"2026-01-16",{"date":415,"type":38},"2025-04-17",{"date":96,"type":21},{"name":418,"class":76},"Cullgen (Shanghai),Inc",{"id":420,"slug":421,"hasResults":11,"nctId":422,"briefTitle":423,"officialTitle":424,"acronym":4,"eligibilityCriteria":425,"healthyVolunteers":11,"sex":16,"minAge":85,"maxAge":4,"enrollmentInfo":426,"targetDuration":4,"studyType":22,"phases":428,"briefSummary":429,"conditions":430,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":433,"lastUpdatePostDateStruct":434,"startDateStruct":436,"completionDateStruct":438,"leadSponsor":440,"locationsCount":99},"100615820","safety-and-feasibility-of-sulforaphane-to-promote-early-haematopoietic-recovery-after-cord-blood-transplantation-100615820","NCT07297576","Safety and Feasibility of Sulforaphane to Promote Early Haematopoietic Recovery After Cord Blood Transplantation","Safety and Feasibility of Sulforaphane to Promote Early Haematopoietic Recovery After Cord Blood Transplantation A Single-arm, Open, Single-centre Clinical Study","Inclusion criteria：\n\n1. Patients with high-risk haematological malignancies: including AML, ALL, high-risk MDS\n2. Age: ≥18 years\n3. Karnofsky score ≥70%, Eastern Cooperative Oncology Group (ECOG) physical status ≤2 points\n4. Selection of non-haematopoietic cord blood: donor-recipient HLA high-resolution compatibility ≥4\u002F6, 7\u002F10 and CD34 cells ≥0.83×105\u002Fkg (recipient's body weight), meeting the above criteria, only cord blood with a freezing time of ≥10 years can be found in China's public umbilical cord blood stem cell banks.\n\nExclusion criteria：\n\n1. Patients who test positive for the following pathogens: HIV (HIV-1\u002F2), human cytomegalovirus (HCMV-DNA), EBV (EBV-DNA), Hepatitis B (positive for Hepatitis B Surface Antigen (HBsAg) or Hepatitis B DNA (HBV-DNA)), Hepatitis C Antibody (HCV-Ab), Treponema pallidum Antibody (TP-Ab).\n2. Active bacterial, viral, fungal or parasitic infections of clinical significance as judged by the investigator at the time of screening\n3. Willing donors with full HLA compatibility and eligible for allogeneic haematopoietic stem cell transplantation\n4. Previous gene therapy or allogeneic haematopoietic stem cell transplant recipients\n5. Immediate family members with known or suspected familial cancer syndromes (including but not limited to hereditary breast and ovarian cancer syndromes, hereditary non-polyposis colorectal cancer syndromes, familial adenomatous polyposis, etc.)\n6. Confirmed diagnosis of a major mental illness or predisposition to mental illness that would seriously affect the ability to participate in clinical research\n7. History of major organ injury, including: Liver lesions: liver function tests suggesting AST or ALT \\> 3 × ULN; total serum bilirubin \\> 2.5 × ULN; total bilirubin \\> 3 × ULN and direct bilirubin \\> 2.5 × ULN if consistent with Gilbert's syndrome; history of hepatic pontine fibrosis, cirrhosis, and the presence of active hepatitis; Cardiac lesions: left ventricular ejection fraction (\"LVEF\") \\\u003C 45%; New York Heart Association (NYHA) class III or IV congestive heart failure (see Appendix 1 for classifications of heart failure); severe heart failure requiring treatment. Cardiac pathology: left ventricular ejection fraction (LVEF) \\\u003C45%; New York Heart Association (NYHA) class III or IV congestive heart failure (see Appendix 1 for NYHA heart failure classification); severe arrhythmia requiring treatment; uncontrolled hypertension or unstable angina; myocardial infarction or bypass or stent surgery within 12 months prior to enrolment; clinically significant valvular disease; calculated eGFR \\\u003C60mL\u002Fmin\u002F1.73m2 and direct bilirubin \\>1.73m2; history of hepatic bridging fibrosis and cirrhosis; and presence of active hepatitis. Lung function: FEV1\u002FFVC \\\u003C60% and\u002For diffusion function \\\u003C60% of predicted value; clinically significant evidence of pulmonary hypertension requiring medical intervention.\n8. Uncorrectable coagulation disorders or history of severe bleeding disorders\n9. Any other condition that, in the opinion of the doctor, makes the subject unsuitable for haematopoietic stem cell transplantation\n10. Known allergy to the test drug or ingredients\n11. Have participated or are participating in other interventional clinical studies within 3 months prior to screening\n12. Live vaccination within 6 weeks prior to screening\n13. Pregnant or breastfeeding women\n14. Subjects did not follow the study protocol well\n15. Any other condition deemed by the investigator to be unsuitable for participation in this clinical trial",{"count":427,"type":21},36,[59],"Umbilical cord blood (UCB) is rich in haematopoietic stem progenitor cells and immune cells, and is used for transplantation for a variety of haematological disorders with the advantages of low mating requirements and fewer transplant complications. By March 2025 China's seven (eight) public cord blood stem cell banks had frozen more than 280,000 public umbilical cord blood, while the percentage of those frozen for ≥10 years was 26%, making clinical application a concern. The previous study showed that long-term freezing impairs cellular mitochondrial function leading to decreased reconstruction of cord blood haematopoietic stem progenitor cells and impaired differentiation into the megakaryotic lineage, and that intervention with the antioxidant radicicol thiols (SFN) can partially rescue the cellular functional damage caused by freezing. The findings were based on immunodeficient animals, and clinical studies are urgently needed to determine whether SFN intervention can promote post-transplant haematopoietic reconstitution in patients with long term cryopreserved (≥10 years) UCB. In this project, the investigators propose to conduct a single-arm, open, single-centre phase I-II clinical study on the safety and feasibility of dietary supplement SFN to promote early haematopoietic restoration after cord blood transplantation to evaluate the safety and feasibility of the use of long-frozen UCB for peri-infusion SFN use in adult transplant recipients, and to reveal the effect of peri-infusion SFN use on neutrophil implantation. This project will provide scientific guidance to promote the clinical application of long-term cryopreserved UCB, as well as key data to optimise the clinical transplantation strategy of UCB and expand its application.",[431,432,28],"ALL (Acute B-Lymphoblastic Leukemia)","AML (Acute Myelogenous Leukemia","2025-12-23",{"date":435,"type":38},"2025-12-30",{"date":437,"type":38},"2025-10-22",{"date":439,"type":21},"2027-06",{"name":441,"class":76},"Institute of Hematology & Blood Diseases Hospital, China",{"id":443,"slug":444,"hasResults":11,"nctId":445,"briefTitle":446,"officialTitle":447,"acronym":4,"eligibilityCriteria":448,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":449,"targetDuration":4,"studyType":110,"phases":4,"briefSummary":451,"conditions":452,"keywords":4,"overallStatus":118,"whyStopped":4,"lastUpdateSubmitDate":455,"lastUpdatePostDateStruct":456,"startDateStruct":458,"completionDateStruct":460,"leadSponsor":462,"locationsCount":296},"100585746","a-long-term-follow-up-study-of-patients-with-ard103-car-t-cell-therapies-100585746","NCT06906380","A Long-term Follow-up Study of Patients With ARD103 CAR-T Cell Therapies","A Long-term Follow-up Study of Patients Enrolled in ARD103_ARCE-CL-P-001 Phase 1\u002F2 Study and Treated With ARD103 CAR-T Cell Therapies","Inclusion Criteria:\n\n* The participant has R\u002FR AML or MDS and has previously received ARD103 CAR-T cell therapies in the parent study.\n* The participant is able to understand and comply with protocol-required study procedures and has provided a written informed consent document.\n\nExclusion Criteria:\n\n* There are no specific exclusion criteria for this study",{"count":450,"type":21},49,"This study will evaluate the long-term safety of ARD103 cellular therapies",[453,454,28],"Acute Myeloid Leukemia, in Relapse","Acute Myeloid Leukemia, in Relapsed or Refractory","2025-12-04",{"date":457,"type":38},"2025-12-08",{"date":459,"type":21},"2026-03-15",{"date":461,"type":21},"2040-10-31",{"name":463,"class":126},"ARCE Therapeutics, Inc.",{"id":465,"slug":466,"hasResults":11,"nctId":467,"briefTitle":468,"officialTitle":469,"acronym":4,"eligibilityCriteria":470,"healthyVolunteers":11,"sex":16,"minAge":85,"maxAge":4,"enrollmentInfo":471,"targetDuration":4,"studyType":22,"phases":472,"briefSummary":473,"conditions":474,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":455,"lastUpdatePostDateStruct":476,"startDateStruct":478,"completionDateStruct":480,"leadSponsor":482,"locationsCount":296},"100568402","phase-1-clinical-study-of-ard103-car-t-therapy-for-patients-with-rr-aml-or-mds-100568402","NCT06680752","Clinical Study of ARD103 CAR-T Therapy for Patients With R\u002FR AML or MDS","A Phase 1\u002F2, Open-label, Multicenter Trial to Assess the Safety and Efficacy of ARD103 in Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome","Inclusion Criteria:\n\n* Documented diagnosis of AML with either refractory or relapsed disease or diagnosis of MDS and ≥ 5% BM blasts\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Adequate hematologic status:\n\n  * Absolute lymphocyte count (ALC) \\> 100\u002Fmm3\n* Adequate renal, hepatic, cardiac and pulmonary function:\n\n  * ALT and AST \\\u003C 3.0 × the ULN\n  * Creatinine clearance ≥ 45.0 mL\u002Fmin as estimated by Cockcroft-Gault and independent dialysis\n  * Total bilirubin ≤ 2.0 mg\u002FdL\n* Pregnancy testing: females of childbearing potential must have a negative serum or urine pregnancy test\n* Contraception: males and females of childbearing potential must agree to use an effective method of contraception\n* Participant is capable of giving signed informed consent\n\nExclusion Criteria:\n\n* Participants with acute promyelocytic leukemia\n* Presence of active and clinically relevant central nervous system (CNS) disorder\n* Autoimmune disease requiring immunosuppressive treatment\n* Participants with known hepatic bridging cirrhosis\n* Currently active infection with hepatitis B or C\n* Previous treatment with investigational gene or cell therapy (including CAR therapy)\n* Any active acute GvHD or systemic treatment of more than 10 mg prednisone daily (or equivalent)\n* Previous chemotherapy including biologic\u002Ftargeted therapy or immunological agents directed to the pathology within 14 days prior to screening and all along the study duration",{"count":450,"type":21},[162,24],"This is a phase I\u002F2, interventional, open-label, multicenter study to assess the safety and efficacy of ARD103 in patients with relapsed or refractory acute myeloid leukemia or myelodysplastic syndrome.",[453,475,28],"Acute Myeloid Leukemia Refractory",{"date":477,"type":38},"2025-12-10",{"date":479,"type":38},"2025-05-20",{"date":481,"type":21},"2028-12",{"name":463,"class":126},{"id":484,"slug":485,"hasResults":11,"nctId":486,"briefTitle":487,"officialTitle":488,"acronym":4,"eligibilityCriteria":489,"healthyVolunteers":276,"sex":16,"minAge":85,"maxAge":339,"enrollmentInfo":490,"targetDuration":4,"studyType":22,"phases":492,"briefSummary":488,"conditions":493,"keywords":495,"overallStatus":118,"whyStopped":4,"lastUpdateSubmitDate":500,"lastUpdatePostDateStruct":501,"startDateStruct":503,"completionDateStruct":505,"leadSponsor":506,"locationsCount":99},"100609398","phase-2-venetoclax--augmented-treosulfan-based-reduced-intensity-conditioning-before-allogeneic-stem-cell-transplantation-100609398","NCT07214064","Venetoclax- Augmented Treosulfan-Based Reduced Intensity Conditioning Before Allogeneic Stem Cell Transplantation","Safety and Feasibility of a Venetoclax- Augmented Treosulfan-Based Reduced Intensity Conditioning Before Allogeneic Stem Cell Transplantation in AML, MDS\u002FAML and Higher Risk MDS","Inclusion Criteria:\n\n1. Age between 18 and 75 years at the time of signing the Informed Consent\n2. Patient is fluent in German\n3. Signed written Informed Consent with the cognitive ability to understand all consequences of trial participation and to comply with all trial related procedures\n4. Diagnosis of AML,MDS\u002FAML (according to ICC 20226) or HRMDS (IPSS-R7 \\>3.5 or IPSS-M8 \\>0; according to ICC 20226 and IWG 20232)\n5. Myeloid neoplasm (AML, MDS\u002FAML or HR-MDS according to ICC 20226) under control\\* at time of screening, defined as one of the following:\n\n   5.1. AML (ICC 20226):\n\n   • Scheduled for alloHCT after prior Remission\n\n   Induction ± Consolidation:\n   * Achievement of at least MLFS\\*\\* (according to ELN 20221 criteria) after up to two cycles of intensive, anthracycline-based induction chemotherapy OR\n   * Achievement of at least MLFS\\*\\* (according to ELN 20221 criteria) after intensive, anthracycline-based induction chemotherapy folllowed by up to three cycles of cytostatic consolidation therapy OR\n   * Achievement of at least MLFS\\*\\* (according to ELN 20221) after less intensive, HMA-based treatment (up to six cycles) OR\n   * Achievement of at least MLFS\\*\\* (according to ELN 20221) after a combination of intensive and less intensive treatments (up to six cycles in total) 5.2. MDS\u002FAML (ICC 20226):• Scheduled for alloHCT after prior Remission\n\n   Induction ± Consolidation:\n   * Achievement of at least MLFS\\*\\* (according to ELN 20221 criteria) after up to two cycles of intensive, anthracycline-based induction chemotherapy OR\n   * Achievement of at least MLFS\\*\\* (according to ELN 20221 criteria), after intensive, anthracycline-based induction chemotherapy folllowed by up to three cycles of cytostatic consolidation therapy OR\n   * Achievement of at least MLFS\\*\\* (according to ELN 20221 criteria) after less intensive, HMA-based treatment (up to six cycles and including HMA monotherapy) OR\n   * Achievement of at least MLFS (according to ELN 20221 criteria) after a combination of intensive and less intensive treatments (up to six cycles in total)• Scheduled for upfront alloHCT:\n   * ≤19% bone marrow blastsAND• ≤19% peripheral blood blastsAND• ≤15.000\u002Fµl peripheral blood Leukocytes 5.3. HR- MDS (ICC 20226, IWG 20232)\n   * Scheduled for alloHCT after prior therapy:\n   * up to six cycles of a less intensive HMAbased treatment or HMA monotherapy AND\n   * ≤9% bone marrow blastsAND• ≤9% peripheral blood blasts• Scheduled for upfront alloHCT:\n   * ≤9% bone marrow blasts AND\n   * ≤9% peripheral blood blasts \\*The disease is considered clinically controlled, when it is either aggressive but has proven responsive to cytostatic chemotherapy (e.g. AML with achievement of at least MLFS) or slowly progressive ( e.g. suitable for upfront alloHCT in cases of MDS\u002FAML) or is both slowly progressive and responsive to therapy\n\n     * a bone marrow assessment is mandatory during screening phase. Patients canonly be enrolled after the according inclusion criteria have been confirmed bybone marrow biopsy. The time window for bone marrow biopsy is day -21 to -14.\n6. Eligiblity for alloHCT according to a board of experienced haematologists\n7. Karnofsky Performance Index ≥60%\n8. Planned alloHCT with Peripheral Blood Stem Cells (PBSC)\n9. Infusion of allogeneic stem cells schedulded between day 14 and day 28 after Screening\n10. Availability of a suitable donor, defind as one of the following:\n\n    10.1. HLA-identical sibling (MSD)OR 10.2. HLA-compatible (9\u002F10 antigens matched for HLA-A, -B, -C, -DRB1, and -DQB1) unrelated donor (MUD) with completed confirmatory typing.\n\n    OR 10.3. Two unrelated donors with \\>90% probability of a 9\u002F10 match for HLA- A, -B, -C, -DRB1, and -DRQB1, according to OptiMatch list (MUD)\n11. Documented diffusion lung capacity for carbon monoxide (DLCO) \\>40% (adjusted for hemoglobin, if available) and FEV1\u002FFVC \\>50%\n12. Left ventricular ejection fraction (LVEF) ≥40%\n13. GFR (CKD-EPI) ≥ 30 ml\u002Fmin\u002F1,73 m2\n14. Bilirubin ≤3x ULN and AST ≤5x ULN\n15. Thoracic imaging (either X-ray or computed tomography (CT)) without evidence of active infection or second malignancy\n16. Subject (male or female) is willing to use highly effective methods during treatment and for 6 months (male or female) after the end of treatment (adequate: combined hormonal contraception associated with inhibition of ovulation, progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomized partner1, sexual abstinence2). Female participants using homonal contraceptives should use a barrier method as well.1 Vasectomized partner is a highly effective birth control method provided that partner is the sole sexual partner of the FCBP trial participant and that the vasectomized partner has received medical assessment of the surgical success2 In the context of this guidance sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject.\n17. Absence of pregnancy confirmed by a highly sensitive pregnancy test not older than 3 days at time of screening (only FCBP).\n18. Subject agrees not to share medication.\n\nExclusion Criteria:\n\n1. APL (AML with t(15;17))\n2. MDS\u002FMPN (ICC 20226)\n3. Karnofsky Performance Index \\\u003C60%\n4. Patient scheduled for haploidentical allogeneic hematopoetic stem cell transplantation or bone marrow stem cell transplantation\n5. Presence of extramedullary myelosarcoma\n6. Disease Relapse after prior CRc\n7. History of allogeneic hematopoietic stem cell transplantation\n8. Significant active cardiac disease within 6 months prior to the start of study treatment, including:\n\n   * New York Heart Association (NYHA) class III or IV congestive heart failure\n   * Myocardial infarction\n   * Unstable angina\n   * Cerebral apoplexy\n   * Severe cardiac arrhythmias\n   * Left ventricular ejection fraction (LVEF) \\\u003C40% by TTE\n9. Documented diffusion lung capacity for carbon monoxide (DLCO) ≤40% (adjusted for hemoglobin, if available) and FEV1\u002FFVC ≤50%\n10. GFR (CKD-EPI) \\\u003C30 ml\u002Fmin\u002F1,73 m2\n11. Bilirubin \\>3x ULN or AST \\>5x ULN\n12. Clinical symptoms suggestive of active central nervous system (CNS) leukemia or known CNS leukemia.\n13. Active viral infection, including hepatitis B, hepatitis C or Human Immunodeficiency Virus (HIV) infection, that is uncontrolled prior to first dose of study treatment and may interfere with the study objectives or which could expose the patient to undue risk through the participation in the clinical trial. An infection controlled with an approved antiviral treatment is allowed.\n14. Presence of Proven, Probable or Possible Invasive Fungal Disease (IFD) as defined by EORTC\u002FMSG 20209 Definitions (please consult Appendix)\n15. Serologies suggestive of recent (\\\u003C6 months) infection or reactivation with\u002Fof Toxoplasma gondii (based on IgG, IgM and Avidity) or of infection with Treponema pallidum (based on TPPA).\n16. Any clinically uncontrolled infection (bacterial or unknown pathogen), defined as persisting or recurring fever or rising levels of CRP (≥10 mg\u002Fdl) despite intravenous antibacterial or antifungal therapy (initiated or escalated at least 72h hours ago)\n17. Immediate life-threatening, severe complications of leukemia such as uncontrolled bleeding and\u002For disseminated intravascular coagulation.\n18. Conditions that limit the ingestion or gastrointestinal absorption of orally administered drugs.\n19. Patients with a currently active second malignancy. Patients are not considered to have a currently active malignancy, if they have completed therapy and are considered by their physician to be at \\\u003C30% risk of relapse within one year. However, patients with the following history\u002Fconcurrent conditions are allowed:\n\n    * Basal or squamous cell carcinoma of the skin;\n    * Carcinoma in situ of the cervix;\n    * Carcinoma in situ of the breast;\n    * Incidental histologic finding of prostate cancer.\n20. Receipt of live, attenuated vaccine within 30 days prior to the study inclusion (NOTE: patients, if enrolled, should not receive live vaccine during the study and until 6 months after the therapy)\n21. Severe neurological or psychiatric disorder interfering with ability to give an informed consent.\n22. Women during pregnancy and lactation.\n23. History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product.\n24. Participation in other trials interfering with the endpoint of this study. Prior trial participation is permitted, provided that treatment with the investigational medicinal product has been completed at least 4 days prior to screening for this trial (at least 10 days before planned study treatment).",{"count":491,"type":21},27,[24],[62,494,28],"MDS\u002FAML",[496,497,498,499],"Allogeneic Stem Cell Transplantation","Venetoclax","Venetoclax- Augmented Treosulfan-Based Reduced Intensity Conditioning","RIC","2025-10-02",{"date":502,"type":38},"2025-10-09",{"date":504,"type":21},"2026-01",{"date":393,"type":21},{"name":507,"class":76},"University Hospital Tuebingen",{"id":509,"slug":510,"hasResults":11,"nctId":511,"briefTitle":512,"officialTitle":513,"acronym":514,"eligibilityCriteria":515,"healthyVolunteers":11,"sex":16,"minAge":85,"maxAge":4,"enrollmentInfo":516,"targetDuration":4,"studyType":22,"phases":518,"briefSummary":519,"conditions":520,"keywords":4,"overallStatus":118,"whyStopped":4,"lastUpdateSubmitDate":522,"lastUpdatePostDateStruct":523,"startDateStruct":525,"completionDateStruct":527,"leadSponsor":528,"locationsCount":77},"100594928","phase-2-evaluation-of-treosulfan-versus-melphalan-conditioning-followed-by-ptcy-in-patients-with-aml-and-mds-undergoing-allogeneic-transplantation-100594928","NCT07025824","Evaluation of Treosulfan Versus Melphalan Conditioning Followed by PTCy in Patients With AML and MDS Undergoing Allogeneic Transplantation","Randomized Evaluation of Treosulfan Versus Melphalan Conditioning Followed by PTCy in Patients With AML and MDS Undergoing Allogeneic Transplantation","RELEVANT","Main Inclusion Criteria:\n\n1. Informed consent signed by the patient capable of giving\n2. Patient scheduled for allogeneic transplantation within the next 3 weeks\n3. Age ≥ 18 years\n4. AML or MDS according to WHO with indication for allogeneic HCT:\n\n   1. AML in first or second complete remission (CR) or complete remission with incomplete hematologic recovery (CRi\u002FCRh) or morphologic leukemia-free state (MLFS)\n   2. MDS according to WHO\n5. Increased risk for treatment-related toxicity by myeloablative conditioning according to at least one of the following criteria:\n\n   1. Patients aged ≥ 50 years at transplant and\u002For\n   2. HCT-CI \\> 2 and\u002For\n   3. AML or MDS scheduled for 2nd allogeneic HCT from different donor with minimum of 12 months after 1st allogeneic HCT\n6. Availability of a suitable donor:\n\n   1. Matched sibling donor (MSD) or\n   2. matched unrelated donor (MUD, 10\u002F10 HLA) or\n   3. mismatched unrelated donor (MMUD, single allele or antigen mismatch at HLA-A, -B, -C, or -DRB1 and no concurrent -DQB1 mismatch (9\u002F10) shown by confirmatory typing) or\n   4. haploidentical family donor\n7. Planned GvHD prophylaxis with standard PTCy (with 50mg\u002Fkg body weight on days +3 and +4)\n8. No history of cardiac disease that preclude allogeneic HCT and absence of active symptoms, otherwise, documented left ventricular ejection fraction\n\n   * 40 %.\n9. No need for supplementary oxygen on day of randomization\n\nMain Exclusion Criteria:\n\n1. Patients with acute promyelocytic leukemia with t(15;17)(q22;q12)\n2. Patients with graft failure after previous allogeneic HCT\n3. Patients with scheduled 2nd allogeneic HCT within 12 months after 1st allogeneic HCT\n4. Pretreatment with either melphalan or treosulfan within the last 12 months prior to randomization\n5. Planned TBI as part of conditioning\n6. Severe organ dysfunction defined by either one of the following criteria:\n\n   1. Serum bilirubin \\> 1.5 × ULN (if not considered Gilbert-syndrome) or\n   2. ALAT or ASAT \\> 5 × ULN\n7. Uncontrolled infection at the time of randomization.\n8. Active viral hepatitis unless serology demonstrates clearance of infection. Occult or prior hepatitis B virus (HBV) infection, defined as negative hepatitis B surface antigen and positive total hepatitis core antibodies, may be included if HBV DNA is undetectable, provided that patients are willing to undergo monthly DNA testing. Patients who have protective titers of hepatitis B surface antibody after vaccination or prior cured hepatitis B are eligible. Patients for hepatitis C virus (HCV) antibody are eligible provided PCR if negative for HCV RNA.\n9. Pregnant or breastfeeding women",{"count":517,"type":21},220,[24],"The aim of this study is to compare the effectiveness and tolerability of two conditioning chemotherapies prior to allogeneic stem cell transplantation.\n\nThe following will also be investigated:\n\n* Survival\n* Remission and Relapse rate\n* Engraftment or graft failure\n* Graft versus Host Disease (GvHD)",[521,28],"AML - Acute Myeloid Leukemia","2025-09-02",{"date":524,"type":38},"2025-09-03",{"date":526,"type":21},"2025-09",{"date":481,"type":21},{"name":149,"class":76},{"id":530,"slug":531,"hasResults":11,"nctId":532,"briefTitle":533,"officialTitle":534,"acronym":4,"eligibilityCriteria":535,"healthyVolunteers":11,"sex":16,"minAge":85,"maxAge":536,"enrollmentInfo":537,"targetDuration":4,"studyType":22,"phases":539,"briefSummary":540,"conditions":541,"keywords":544,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":551,"startDateStruct":553,"completionDateStruct":555,"leadSponsor":557,"locationsCount":46},"100584659","phase-2-anti-nkg2a-monoclonal-antibody-for-aml-or-mds-patients-undergoing-haploidentical-transplantation-100584659","NCT06892223","Anti-NKG2A Monoclonal Antibody for AML or MDS Patients Undergoing Haploidentical Transplantation","Phase II Clinical Trial to Optimize the Dose of an Anti-NKG2A Monoclonal Antibody (humZ270 MAb, IPH2201) for Patients with Acute Myeloid Leukemia or Myelodysplastic Syndrome Undergoing Haploidentical Transplantation with Post- Transplantation Cyclophosphamide","Inclusion Criteria:\n\n1. Patients capable of providing informed consent according to ICH\u002F GCP, and national\u002Flocal regulations and be willing to comply with all study-related procedures.\n2. Adult patients aged ≥18 years old, without any restriction of gender and race.\n3. Patients with a hematologic malignancy represented either by Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) or Myelodysplastic syndrome\u002FMyeloproliferative neoplasm (MDS\u002FMPN).\n4. Patients lacking a HLA identical donor and receiving haploidentical stem cell transplant with GVHD\u002FHVG prophylaxis consisting of Cyclophosphamide: 40 or 50 mg\u002Fkg\u002Fday, day +3 and +4, Cyclosporine A: 3 mg\u002Fkg\u002Fday from day +5, Mycophenolate mofetil: 45 mg\u002Fkg\u002Fday, from day +5 to day +35.\n5. Patient who has received haplo-SCT with a myeloablative or reduced intensity or nonmyeloblative conditioning followed, either by a bone marrow or a peripheral blood stem cell (PBSC) graft.\n6. Negative beta-human chorionic gonadotropin (β-HCG) pregnancy test within 8 days prior to start of study drug for women of childbearing potential.\n7. Women of childbearing potential must agree to use a highly effective method of contraception from the time of giving informed consent until at least 52 weeks after the last dose of study therapy. Men with female partners who are of childbearing potential must agree that they will use a highly effective method of contraception from the time of giving informed consent until at least 52 weeks after the patient receives his last dose of study therapy contraception.\n\nExclusion Criteria:\n\n1. Patients aged \\\u003C 18 years old.\n2. Active uncontrolled infections.\n3. CNS involvement of AML disease.\n4. Karnofsky performance status (KPS) \\\u003C60% or severe organ dysfunction, including a left ventricular ejection fraction \\\u003C40%, DLCO \\\u003C50% or creatinine clearance \\\u003C50 ml\u002Fmin (as per transplant eligibility).\n5. Pregnant or breast-feeding or intending to become pregnant during the study.\n6. Patients who rapidly relapse after allogenic-SCT before day 30 after allogenic-SCT.\n7. Patients who experience acute GVHD before day +30 after allogenic-SCT.\n8. Patients treated with a second allogeneic Allo-SCT.","99 Years",{"count":538,"type":21},42,[24],"The goal of this clinical trial is to evaluate the effectiveness and safety of the anti-NKG2A monoclonal antibody (Monalizumab) in patients undergoing haploidentical stem cell transplantation (Haplo-SCT) with post-transplantation cyclophosphamide (PT-Cy). The main questions this trial aims to answer are:\n\n* Does Monalizumab improve graft-versus-host disease-free and progression-free survival (GPFS) in patients after Haplo-SCT?\n* What are the safety and side effects of Monalizumab in this patient group?\n* How does Monalizumab affect the reconstitution and function of NK cells in patients undergoing Haplo-SCT?\n* Researchers will administer Monalizumab to participants on day +30 and +44 after transplantation to see if it enhances immune responses and prevents disease relapse or GVHD.\n\nParticipants will:\n\n* Receive Monalizumab intravenously at 1 mg\u002Fkg on day +30 and day +44 after Haplo-SCT\n* Be monitored for clinical outcomes such as GVHD, survival rates, and immune function for up to one year after the transplant\n* Undergo regular checkups and tests to assess the effectiveness and safety of the treatment",[542,28,543],"Acute Myeloid Leukaemia","MPN (Myeloproliferative Neoplasms)",[545,546,547,548,549,550],"MONALIZUMAB","ALLOGENIC TRANSPLANT","ACUTE MYELOID LEUKEMIA","MYELODYSPLASTIC SYNDROM","MYELOPROLIFERATIVE NEOPLASM","GVHD",{"date":552,"type":38},"2025-03-24",{"date":554,"type":38},"2021-12-03",{"date":556,"type":21},"2026-12",{"name":558,"class":76},"Istituto Clinico Humanitas"]