NCT06471946

VA Conditioning Regimen Allo-HSCT for Elderly Higher-risk MDS

Venetoclax Plus Azacytidine Conditioning Regimen Allo-HSCT for Elderly Patients With Higher-risk Myelodysplastic Syndromes

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Navy General Hospital, Beijing · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

Summary

The goal of this phase 1/2 trial is to test the safety and efficacy of Venetoclax Plus Azacytidine Conditioning Regimen Allo-HSCT in treating patients with higher-risk MDS.

Detailed description

The investigators will evaluate 2 year overall survival(OS) after transplantation in patients with higher-risk MDS. Progression free survival (PFS), incidence of acute GVHD, non-relapse mortality (NRM), graft-versus-host disease (GVHD)-free relapse-free survival(GRFS), and incidence of chronic GVHD at 1 and 2 years after transplantation will be counted.

Conditions

• Higher-risk Myelodysplastic Syndromes

Interventions

Type	Name	Description
DRUG	Venetoclax Plus Azacytidine Conditioning Regimen Allo-HSCT	Patients were treated by VA Conditioning Regimen Allo-HSCT: Venetoclax 100mg po qd d1, 200mg po qd d2, 400mg po qd d3-14; Azacytidine 75 mg/m2 subcutaneous injection qd d1-7, donor stem cells infused from d9

Timeline

• Start date: 2024-10-01
• Primary completion: 2029-09-01
• Completion: 2030-09-01
• First posted: 2024-06-24
• Last updated: 2024-10-01

Locations

1 site across 1 country: China