Clinical Study of Venetoclax Combined With Azacitidine as Bridging Therapy Prior to Hematopoietic Stem Cell Transplantation in Patients With Higher-Risk Myelodysplastic Syndromes
Recruiting now · Phase 2
Conditions studied: Myelodysplastic Neoplasms, Transplantation
In brief
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)
Key facts
- Study ID
- NCT07047183
- Run by
- Yehui Tan
- People needed
- 46
- Starts
- 2025-07-01
- Expected to finish
- 2029-06-30
- Last updated by the study team
- 2025-08-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Newly diagnosed MDS confirmed by morphological and immunophenotypic analysis of bone marrow；
- Age ≥18 years, any gender；
- Bone marrow blasts ≥10%；
- IPSS-R score >4.5；
- ECOG performance status 0-2；
- Scheduled for allogeneic hematopoietic stem cell transplantation (allo-HSCT)；
- Adequate major organ function：
- Cardiac: LVEF ≥50%
- Hepatic: Bilirubin ≤1.5×ULN
- AST/ALT ≤2.5×ULN
- Renal: Creatinine clearance ≥60 mL/min；
- Written informed consent provided by the patient or legally authorized representative.
You may not qualify if…
- Extramedullary disease involvement；
- Hypersensitivity to any study drugs；
- Clinically significant hepatic/renal dysfunction exceeding inclusion thresholds；
- Severe cardiac disease, including congestive heart failure, myocardial infarction, and cardiac insufficiency;
- Concurrent malignant tumors of other organs, which can be enrolled if previously cured;
- Active tuberculosis or HIV infection;
- Concomitant hematologic disorders;
- Pregnancy or lactation;
- Inability to comply with protocol requirements;
- Concurrently participating in other clinical studies.
Where it is running
- The First Hospital of Jilin University — Changchun, Jilin, China (enrolling)
Full record on ClinicalTrials.gov
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