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Venetoclax-containing Therapy Combined With Microtransplant for Intermediate-risk and Higher MDS
Sponsor: Beijing 302 Hospital
Summary
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.
Official title: Phase 2 Study of Venetoclax-containing Therapy in Combination With HLA-mismatched Mobilized Peripheral Blood Mononuclear Cell Infusion for Intermediate-risk and Higher Myelodysplastic Syndromes
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2025-06-20
Completion Date
2031-06
Last Updated
2025-11-25
Healthy Volunteers
No
Conditions
Interventions
Venetoclax
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)
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
HLA-mismatched donor GPBMCs are infused on Day 15.
Locations (1)
Department of Hematology, the Fifth Medical Center of Chinese PLA General Hospital
Beijing, China