Venetoclax-containing Therapy Combined With Microtransplant for Intermediate-risk and Higher MDS
Sponsor: Beijing 302 Hospital • ClinicalTrials.gov ID: NCT07238686
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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.
Interventions
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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.
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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.
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GPBMC infusion
(Biological)
HLA-mismatched donor GPBMCs are infused on Day 15.
Eligibility criteria
Conditions
Locations
- Department of Hematology, the Fifth Medical Center of Chinese PLA General Hospital — Beijing, China
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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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