A Phase 2 interventional study of VEN (Venetoclax) in Myelodysplastic Neoplasms and Transplantation, sponsored by Yehui Tan. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-08.
Sponsored by Yehui Tan · Phase 2, Interventional, and Treatment
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)
This is a single-center, single-arm, prospective study investigating pre-transplant bridging therapy in patients aged ≥18 years with higher-risk MDS-IB2. The study plans to enroll 46 eligible patients. Participants will receive Venetoclax combined with Azacitidine, administered in 28-day cycles for 1 to 2 cycles. Treatment response will be assessed according to the IWG 2023 HR-MDS response criteria.Patients achieving modified Composite Complete Remission (mCRc: CR or CR-equivalent + CRL + CRh) after Cycle 1 will proceed directly to transplantation. Patients not achieving mCRc will receive a second cycle of therapy. All patients will undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT) within 3 months after completing Cycle 2, regardless of mCRc status. Patients unable to proceed to transplantation will receive standard institutional care and undergo follow-up.
Yehui Tan is the lead sponsor of 3 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adequate major organ function：
Exclusion Criteria:
Drug: VEN (Venetoclax)
Enrolled 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
Also known as: Azacitidine
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
Time frame: From date of index treatment to death, disease progression, or end of study, whichever came first, assessed up to 24 months.
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.
Time frame: From date of index treatment to death, disease progression, or end of study, whichever came first, assessed up to 48 months.
Cumulative Relapse Rate (CIR)
Defined as the proportion of patients who experience disease relapse from the time of enrollment in this study.
Time frame: rom date of index treatment to death, disease progression, or end of study, whichever came first, assessed up to 24 months.
Composite Complete Response Rate（mCRc）
Complete Remission (CR) or CR-equivalent+ CR with partial hematologic recovery (CRL) + CR with limited hematologic recovery (CRh)
Time frame: Through study completion, an average of 1 year
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