Venetoclax-containing Therapy Combined With Microtransplant for Intermediate-risk and Higher MDS

Sponsor
Beijing 302 Hospital
Study ID
NCT07238686
Phase
PHASE2
Status
Recruiting
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Conditions

  • Myelodysplastic Syndromes

Eligibility Criteria

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

Interventions

  • Venetoclax — DRUG
    Given PO. For the first cycle, dose of 100 mg on Day 1, 200 mg on Day 2, and 400 mg on Days 3-14. For other cycles, dose of 400 mg on Days 1-14. Note: The dose should be reduced to 100-200 mg daily if concomitant azole antifungals are required.
  • Azacitidine (AZA) or Decitabine (DAC) — DRUG
    AZA: Given SC. Dose of 75 mg/m² on Days 1-7 of each cycle. DAC: Given IV. Dose of 20 mg/m² on Days 1-5 of each cycle.
  • GPBMC infusion — BIOLOGICAL
    HLA-mismatched donor GPBMCs are infused on Day 15.

Study Details

This study aims to evaluate the safety and efficacy of a Venetoclax and hypomethylating agent-based regimen combined with infusion of HLA-mismatched donor G-CSF mobilized peripheral blood mononuclear cells (GPBMC) in patients with intermediate-risk and higher myelodysplastic syndromes who are ineligible for allogeneic hematopoietic stem cell transplantation.

Key Dates

Start date
Jun 20, 2025
Status verified
Jul 2025
Primary completion
Jun 30, 2030
Completion
Jun 30, 2031

Study Design

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

Arms

  • Experimental: Cohort 1
    This cohort includes patients with intermediate-risk and higher MDS who are ineligible for or refuse allogeneic HSCT. Patients receive Venetoclax in combination with hypomethylating agent and HLA-mismatched donor GPBMC infusion. Treatment cycles are 28 days, repeated until disease progression or unacceptable toxicity.

Primary Outcome Measure

Overall survival (OS) [ Time Frame: Measured up to 4 years after the last participant is enrolled ]

Central Contacts

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