Status:
COMPLETED
ASTX727 and Donor Lymphocyte Infusions After Allogenic Stem Cell Transplantation in Very High Risk MDS or AML Patients
Lead Sponsor:
Groupe Francophone des Myelodysplasies
Collaborating Sponsors:
Astex Pharmaceuticals, Inc.
Conditions:
MDS
AML
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
June 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 22 2025
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT04857645
Start Date
June 22 2021
End Date
April 22 2025
Last Update
May 14 2025
Active Locations (12)
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1
CHU d'Amiens Picardie - Site sud - Service hématologie clinique et thérapie cellulaire
Amiens, France, 80054
2
CHU d'Angers - Service des maladies du sang
Angers, France, 49933
3
CHU Estaing - Service hématologie clinique et thérapie cellulaire
Clermont-Ferrand, France, 63000
4
CHU de Grenoble - Clinique Universitaire d'hématologie
Grenoble, France, 38043