Clinical Study of Venetoclax Combined With Azacitidine as Bridging Therapy Prior to Hematopoietic Stem Cell Transplantation in Patients With Higher-Risk Myelodysplastic Syndromes

Sponsor
Yehui Tan
Study ID
NCT07047183
Phase
PHASE2
Status
Recruiting
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Conditions

  • Myelodysplastic Neoplasms
  • Transplantation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • VEN (Venetoclax) — DRUG
    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

Study Details

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 Dates

Start date
Jul 1, 2025
Status verified
Aug 2025
Primary completion
Jun 30, 2029
Completion
Jun 30, 2029

Study Design

Enrollment
46 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: venetoclax + Azacitidine

Primary Outcome Measure

2-Year Relapse-Free Survival(2-RFS) [ Time Frame: From date of index treatment to death, disease progression, or end of study, whichever came first, assessed up to 24 months. ]

Central Contacts

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