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RECRUITING
NCT07238686
PHASE2

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

Sponsor: Beijing 302 Hospital

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

DRUG

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.

BIOLOGICAL

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