ASTX727 and Donor Lymphocyte Infusions After Allogenic Stem Cell Transplantation in Very High Risk MDS or AML Patients
- Registration Number
- NCT04857645
- Lead Sponsor
- Groupe Francophone des Myelodysplasies
- Brief 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 57
- Patients aged from 18 to 70 years
- MDS or AML with unfavorable genetics defined as follow:
- 4 or more cytogenetic abnormalities or
- 3 cytogenetic abnormalities and TP53 or other unfavorable mutations (ASXL1, RUNX1) or
- 3 cytogenetic abnormalities and monosomal karyotype or
- mutations involving EVI1
- AML patients should have received chemotherapy
- Marrow blast < 20% for MDS and < 10% for AML post chemotherapy
- For MDS : Revised IPSS poor or very poor ; For AML : ELN adverse risk
- Non-proliferative disease
- A donor is available (HLA matched or mismatched)
- Adequate contraception in women < 50 years and for men. Subjects must agree to use, and to be able to comply with, effective contraception without interruption, at least the first six months after transplant, throughout the entire duration of study drug therapy and for at least 6 months for women and 3 months for men after the last dose of study drug therapy.
- ECOG 3 or more
- Cancer less than 2 years before inclusion or cancer not in remission the last 2 years before inclusion (except in situ cancer or baso cellular cancer)
- Cardiac failure with Ejection Fraction < 50%
- Creatininemia level > 150 µmol/L
- Liver enzyme > 3 N
- Conjugated bilirubinemia > 25 µmol/L
- MDS occurring in patients with Fanconi anemia or congenital dyskeratosis
- Proliferative disease in patients not in remission: White Blood Cell (WBC) > 15 G/L or use of continuous cytotoxic to maintain WBC < 15 G/L
- AML with marrow or peripheral blast count higher than 10% after chemotherapy
- Known allergy or hypersensitivity to the investigational agent or decitabine or its metabolites or formulation excipients
- No contraception
- Pregnant or breastfeeding women
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ASTX727 treatment Donor Lymphocyte Infusions - ASTX727 treatment ASTX727 -
- Primary Outcome Measures
Name Time Method Disease free Survival (DFS) at one year post transplant 1 year post transplant Measure of time during which no sign of progression is found
- Secondary Outcome Measures
Name Time Method Overall Survival (OS) at one year post transplant 1 year post transplant Measure of time from randomization to death from any cause
Overall Survival (OS) at two years post transplant 2 years post transplant Measure of time from randomization to death from any cause
Risk factors for DFS, OS and non-relapse mortality at 1 and 2 years 1 and 2 years Statistical study of cumulative incidence curves
Trial Locations
- Locations (12)
CHU d'Angers - Service des maladies du sang
🇫🇷Angers, France
CHU de Grenoble - Clinique Universitaire d'hématologie
🇫🇷Grenoble, France
CHU d'Amiens Picardie - Site sud - Service hématologie clinique et thérapie cellulaire
🇫🇷Amiens, France
CHU Estaing - Service hématologie clinique et thérapie cellulaire
🇫🇷Clermont-Ferrand, France
Hôpital Saint Eloi - Service hématologie clinique
🇫🇷Montpellier, France
CHU Hôtel Dieu - Service hématologie clinique
🇫🇷Nantes, France
Hôpital Saint Louis - Service hématologie-greffe
🇫🇷Paris, France
CH Lyon Sud - Servide Hématologie
🇫🇷Pierre-Bénite, France
Centre Henri Becquerel - Département d'hématologie
🇫🇷Rouen, France
CHU Brabois - Service hématologie clinique
🇫🇷Vandœuvre-lès-Nancy, France
IUCT Oncopole - Département d'hématologie - Service de greffe de cellules souches hématopoïétiques
🇫🇷Toulouse, France
CHU de Haut-Lévèque de Bordeaux - Service des maladies du sang
🇫🇷Pessac, France