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)
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；
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;
Single group
VEN (Venetoclax)
DrugEnrolled patients will receive: Venetoclax: 100 mg on Day 1, 200 mg on Day 2, and 400 mg on Days 3-14. Azacitidine: 75 mg/m² on Days 1-7. Cycle duration: 28 days Total cycles: 1 to 2 cycles
2-Year Relapse-Free Survival(2-RFS)
Defined as the time from enrollment in this study to the occurrence of relapse. For patients without relapse, the time is calculated until death from any cause or the time of the last follow-up
Overall Survival (OS)
Defined as the time from enrollment in this study to death from any cause. If the exact date of death is unknown, the time of death is defined as the last contact date. If the patient is still alive, the last observed time will be used, and the patient's OS will be considered for analysis.
Cumulative Relapse Rate (CIR)
Defined as the proportion of patients who experience disease relapse from the time of enrollment in this study.
Composite Complete Response Rate（mCRc）
Complete Remission (CR) or CR-equivalent+ CR with partial hematologic recovery (CRL) + CR with limited hematologic recovery (CRh)
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Yehui Tan
Lead sponsor
The First Hospital of Jilin University
Sponsor institution
