Venetoclax plus azacitidine as a bridge to stem-cell transplant for higher-risk MDS-IB2

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, single-arm Phase 2 study enrolling about 46 adults with higher‑risk MDS‑IB2 and marrow blasts ≥10% who are planned for allogeneic hematopoietic stem-cell transplantation. Participants receive venetoclax combined with azacitidine in 28‑day cycles for one or two cycles, with response measured by the IWG 2023 HR‑MDS criteria. Patients who achieve a modified composite complete remission (mCRc) after Cycle 1 proceed directly to transplant, while others receive a second cycle and all are intended to undergo transplant within three months after completing Cycle 2. Patients unable to proceed to transplant will receive standard institutional care and continue follow‑up.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Newly diagnosed MDS confirmed by morphological and immunophenotypic analysis of bone marrow；
2. Age ≥18 years, any gender；
3. Bone marrow blasts ≥10%；
4. IPSS-R score \>4.5；
5. ECOG performance status 0-2；
6. Scheduled for allogeneic hematopoietic stem cell transplantation (allo-HSCT)；
7. Adequate major organ function：

   * Cardiac: LVEF ≥50%
   * Hepatic: Bilirubin ≤1.5×ULN
   * AST/ALT ≤2.5×ULN
   * Renal: Creatinine clearance ≥60 mL/min；
8. Written informed consent provided by the patient or legally authorized representative.

Exclusion Criteria:

1. Extramedullary disease involvement；
2. Hypersensitivity to any study drugs；
3. Clinically significant hepatic/renal dysfunction exceeding inclusion thresholds；
4. Severe cardiac disease, including congestive heart failure, myocardial infarction, and cardiac insufficiency;
5. Concurrent malignant tumors of other organs, which can be enrolled if previously cured;
6. Active tuberculosis or HIV infection;
7. Concomitant hematologic disorders;
8. Pregnancy or lactation;
9. Inability to comply with protocol requirements;
10. Concurrently participating in other clinical studies.

Where it's running

• The First Hospital of Jilin University
  Changchun, Jilin, China Recruiting

Study contacts

• Study coordinator: Yehui Tan
• Email: yhtan@jlu.edu.cn
• Phone: 8615948027438

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.