ASTX727 and Donor Lymphocyte Infusions After Allogenic Stem Cell Transplantation in Very High Risk MDS or AML Patients
NCT04857645 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 57
Last updated 2025-05-14
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
Conditions
Interventions
- 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
Sponsors & Collaborators
-
Astex Pharmaceuticals, Inc.
collaborator INDUSTRY -
Groupe Francophone des Myelodysplasies
lead OTHER
Principal Investigators
-
Marie ROBIN, MD · Hôpital Saint Louis - Service hématologie-greffe
-
Pierre FENAUX, MD · Hôpital Saint Louis - Service hématologie séniors
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-06-22
- Primary Completion
- 2024-04-30
- Completion
- 2025-04-22
Countries
- France
Study Locations
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