NCT05226455

Venetoclax in Patients With MDS or AML in Relapse After AHSCT

A Phase I-II Study to Assess Venetoclax + Azacitidine and Donor Lymphocyte Infusion in Patients With MDS or AML in Relapse After Allohematopoietic Stem Cell Transplantation

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 55 (estimated)
• Sponsor: Groupe Francophone des Myelodysplasies · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Study to assess venetoclax + azacitidine and donor lymphocyte infusion (DLI) in patients with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) in relapse after allohematopoietic stem cell transplantation (AHSCT).

Detailed description

A phase I-II study to assess venetoclax + azacitidine and donor lymphocyte infusion (DLI) in patients with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) in relapse after allohematopoietic stem cell transplantation (AHSCT).

Conditions

• MDS
• AML

Interventions

Type	Name	Description
DRUG	venetoclax + azacitidine +/- donor lymphocyte infusion	Venetoclax will be given once daily orally on days 1 to 14 for all cycles. Venetoclax + azacitidine +/- donor lymphocyte infusion (12 cycles maximum)

Timeline

• Start date: 2022-11-23
• Primary completion: 2026-11-15
• Completion: 2027-09-01
• First posted: 2022-02-07
• Last updated: 2026-03-12

Locations

11 sites across 1 country: France