NCT04857645

ASTX727 and Donor Lymphocyte Infusions After Allogenic Stem Cell Transplantation in Very High Risk MDS or AML Patients

A Phase II Prospective Study "GFM-DACORAL-DLI" ASTX727 and Donor Lymphocyte Infusions After Allogenic Stem Cell Transplantation in Very High Risk MDS or AML Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Groupe Francophone des Myelodysplasies · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Study of early administration of ASTX727 associated with late Donor Lymphocyte Infusions after allogenic stem cell transplantation in very high risk MDS or AML patients

Detailed description

Prospective study of early administration of ASTX727 associated with late Donor Lymphocyte Infusions after allogenic stem cell transplantation in very high risk MDS or AML patients

Conditions

• MDS
• AML

Interventions

Type	Name	Description
DRUG	ASTX727	Eligible patient started ASTX727 between 40 and 130 days after allogenic stem cell transplantation
OTHER	Donor Lymphocyte Infusions	In absence of previous grade 2-4 or chronic graft-versus-host disease (GVHD), DLI will be administered at increasing doses the first day of ASTX727 cycles

Timeline

• Start date: 2021-06-22
• Primary completion: 2024-04-30
• Completion: 2025-04-22
• First posted: 2021-04-23
• Last updated: 2025-05-14

Locations

12 sites across 1 country: France