[{"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":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100566134","phase-1-a-study-of-jnj-90189892-for-relapsed-or-refractory-acute-myeloid-leukemia-or-myelodysplastic-neoplasms-100566134",false,"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","ALL","18 Years",{"count":19,"type":20},155,"ESTIMATED","INTERVENTIONAL",[23],"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).",[26,27],"Leukemia, Myeloid, Acute","Myelodysplastic Neoplasms","RECRUITING","2026-06-04",{"date":31,"type":32},"2026-06-05","ACTUAL",{"date":34,"type":32},"2025-03-21",{"date":36,"type":20},"2028-11-21",{"name":38,"class":39},"Janssen Research & Development, LLC","INDUSTRY",9,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":65},"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":49,"type":20},46,[51],"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)",[27,54],"Transplantation","2025-08-05",{"date":57,"type":32},"2025-08-08",{"date":59,"type":32},"2025-07-01",{"date":61,"type":20},"2029-06-30",{"name":63,"class":64},"Yehui Tan","OTHER",1]