[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"myelodysplastic-neoplasms\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:myelodysplastic-neoplasms":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,47,73],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100650742","first-line-luspatercept-in-transfusion-dependent-lower-risk-myelodysplastic-neoplasms-100650742",false,"NCT07752121","First-Line Luspatercept in Transfusion-Dependent Lower-Risk Myelodysplastic Neoplasms","A Prospective, Multicenter, Non-Interventional Study Assessing First-line Luspatercept in Anemic Patients With Very Low, Low, or Intermediate Risk Myelodysplastic Neoplasms Requiring Red Blood Cell Transfusions","LUNIS","Inclusion Criteria:\n\n* Males and females ≥18 years of age at enrollment.\n* Documented diagnosis of myelodysplastic neoplasms according to World Health Organisation (WHO) 2022 or WHO 2016 classification meeting International Prognostic Scoring System-Revised (IPSS-R) criteria for very low-, low-, or intermediate-risk disease.\n* Documented red blood cell transfusion dependence of ≥2 units of red blood cells within the 8 weeks preceding Day 1 treatment initiation.\n* First-line treatment based on the approved luspatercept label and decision for treatment with luspatercept as assessed by the treating physician prior to study participation\n* Provision of written informed consent.\n\nExclusion Criteria:\n\n* Contraindication according to the Reblozyl® (luspatercept) Summary of Product Characteristics (SmPC).\n* Parallel participation in an interventional clinical trial (except follow-up phase as specified in protocol).\n\nPatients who have completed their participation in an interventional clinical trial or who are not receiving any study drug anymore and who are only in the follow-up phase can be enrolled. For blinded studies, the study drug administered needs to be known at the time of enrolment.\n\n• Concurrent malignancy requiring treatment.","ALL","18 Years",{"count":20,"type":21},190,"ESTIMATED","OBSERVATIONAL","This study will observe adults with lower-risk myelodysplastic neoplasms (MDS) who have anemia requiring regular red blood cell transfusions and who are prescribed first-line luspatercept as part of routine medical care. The study will follow participants for up to 2 years to understand how often treatment leads to periods without transfusions, changes in hemoglobin levels, health-related quality of life, and safety outcomes. Information on treatment use and outcomes in routine clinical practice in Germany will also be collected.",[25],"Myelodysplastic Neoplasms",[25,27,28,29,30,31,32,33],"Myelodysplastic Syndromes","MDS","Lower-Risk MDS","RBC Transfusion Dependent","Anemia","Luspatercept","Reblozyl","NOT_YET_RECRUITING","2026-08-06",{"date":37,"type":38},"2026-08-07","ACTUAL",{"date":40,"type":21},"2026-08-24",{"date":42,"type":21},"2030-08-31",{"name":44,"class":45},"Bristol-Myers Squibb","INDUSTRY",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":72},"100566134","phase-1-a-study-of-jnj-90189892-for-relapsed-or-refractory-acute-myeloid-leukemia-or-myelodysplastic-neoplasms-100566134","NCT06651229","A Study of JNJ-90189892 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms","A Phase 1, First-in-Human, Dose Escalation Study of JNJ-90189892 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms","Inclusion Criteria:\n\n* A. For Parts 1, 2, and 3: Have a diagnosis, per the world health organization (WHO) 2022 criteria, of (a) Parts 1, 2, and 3: Acute myeloid leukemia (AML) or (b) Parts 1 and 2: Moderate high, high, or very high-risk myelodysplastic neoplasms (MDS) per Molecular International Prognostic Scoring System (IPSS-M); B. For Part 4 only: Previously untreated acute myeloid leukemia (AML) per the WHO 2022 criteria\n* Body weight that is greater than or equals to (\\>=) 40 kg\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2\n* Have adequate renal function defined as Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Estimated Glomerular Filtration Rate (eGFR) \\>=40 milligrams per minute (mL\u002Fmin) computed with the calculator on the national kidney foundation website\n* Participants must have laboratory parameters in the required range\n\nExclusion Criteria:\n\n* Has a medical history of clinically significant pulmonary compromise, particularly the current need for supplemental oxygen use to maintain adequate oxygenation\n* Has evidence of uncontrolled systemic viral, bacterial, or fungal infection. Antimicrobial prophylaxis is permitted\n* All participants- Has known allergies, hypersensitivity, or intolerance to JNJ-90189892 or its excipients; Parts 3 and 4- Has known allergies, hypersensitivity, or intolerance to venetoclax (VEN), azacitadine (AZA), or their excipients\n* Had major surgery or had significant traumatic injury within 14 days of planned first dose of JNJ-90189892\n* Had a prior or concurrent second malignancy with natural history or treatment likely to interfere with any study endpoints of safety or the efficacy of the study treatment\n* Has known active central nervous system involvement",{"count":55,"type":21},155,"INTERVENTIONAL",[58],"PHASE1","The purpose of Part 1 (Dose Escalation) of the study is to assess the effective dose (recommended Phase 2 dose\\[s\\] \\[RP2Ds\\]) that can be safely administered, and dosing regimens of JNJ-90189892 in participants with relapsed or refractory (R\u002FR) acute myeloid leukemia (AML) or R\u002FR higher-risk type of myelodysplastic neoplasms (MDS \\[type of cancer of the blood and bone marrow, which does not respond to treatment or comes back after treatment\\]). The purpose of Part 2 (Cohort Expansion) is to further assess the safety, tolerability and efficacy in participants with R\u002FR AML or higher-risk types of MDS at the RP2D regimen(s). The purpose of Part 3 and 4 is to assess the effective dose (recommended Phase 2 combination dose \\[RP2CD\\]) that can be safely administered, and dosing regimens of JNJ-90189892 in combination with azacitadine (AZA) + venetoclax (VEN) in participants with R\u002FR AML (part 3) and newly diagnosed (ND) AML (part 4).",[61,25],"Leukemia, Myeloid, Acute","RECRUITING","2026-07-02",{"date":65,"type":38},"2026-07-06",{"date":67,"type":38},"2025-03-21",{"date":69,"type":21},"2028-11-21",{"name":71,"class":45},"Janssen Research & Development, LLC",9,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":56,"phases":82,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":46},"100596570","phase-2-clinical-study-of-venetoclax-combined-with-azacitidine-as-bridging-therapy-prior-to-hematopoietic-stem-cell-transplantation-in-patients-with-higher-risk-myelodysplastic-syndromes-100596570","NCT07047183","Clinical Study of Venetoclax Combined With Azacitidine as Bridging Therapy Prior to Hematopoietic Stem Cell Transplantation in Patients With Higher-Risk Myelodysplastic Syndromes","A Single-Arm, Prospective Clinical Study of Venetoclax Combined With Azacitidine Followed by Bridging Transplantation in Patients With High-Risk Myelodysplastic Neoplasms With Increased Blasts 2 (MDS-IB2)","Inclusion Criteria:\n\n1. Newly diagnosed MDS confirmed by morphological and immunophenotypic analysis of bone marrow；\n2. Age ≥18 years, any gender；\n3. Bone marrow blasts ≥10%；\n4. IPSS-R score \\>4.5；\n5. ECOG performance status 0-2；\n6. Scheduled for allogeneic hematopoietic stem cell transplantation (allo-HSCT)；\n7. Adequate major organ function：\n\n   * Cardiac: LVEF ≥50%\n   * Hepatic: Bilirubin ≤1.5×ULN\n   * AST\u002FALT ≤2.5×ULN\n   * Renal: Creatinine clearance ≥60 mL\u002Fmin；\n8. Written informed consent provided by the patient or legally authorized representative.\n\nExclusion Criteria:\n\n1. Extramedullary disease involvement；\n2. Hypersensitivity to any study drugs；\n3. Clinically significant hepatic\u002Frenal dysfunction exceeding inclusion thresholds；\n4. Severe cardiac disease, including congestive heart failure, myocardial infarction, and cardiac insufficiency;\n5. Concurrent malignant tumors of other organs, which can be enrolled if previously cured;\n6. Active tuberculosis or HIV infection;\n7. Concomitant hematologic disorders;\n8. Pregnancy or lactation;\n9. Inability to comply with protocol requirements;\n10. Concurrently participating in other clinical studies.",{"count":81,"type":21},46,[83],"PHASE2","A Single-Arm, Prospective Clinical Study of Venetoclax Combined with Azacitidine Followed by Bridging Transplantation in Patients with High-Risk Myelodysplastic Neoplasms with Increased Blasts 2 (MDS-IB2)",[25,86],"Transplantation","2025-08-05",{"date":89,"type":38},"2025-08-08",{"date":91,"type":38},"2025-07-01",{"date":93,"type":21},"2029-06-30",{"name":95,"class":96},"Yehui Tan","OTHER"]