NCT07238686

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Beijing 302 Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myelodysplastic Syndromes

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-06-20
• Primary completion: 2030-06-01
• Completion: 2031-06-01
• First posted: 2025-11-20
• Last updated: 2025-11-25

Locations

1 site across 1 country: China