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

  • STATUS
    Recruiting
  • End date
    Jan 27, 2025
  • participants needed
    40
  • sponsor
    Groupe Francophone des Myelodysplasies
Updated on 27 November 2021
cell transplantation
blast cells
TP53

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

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

Details
Condition Acute myeloid leukemia, miller-dieker syndrome, MYELODYSPLASTIC SYNDROME, MDS, myelodysplastic syndromes, myelodysplastic syndrome (mds), acute myelogenous leukemia, anll, acute myeloblastic leukemia
Treatment Donor Lymphocyte Infusions, ASTX727
Clinical Study IdentifierNCT04857645
SponsorGroupe Francophone des Myelodysplasies
Last Modified on27 November 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients aged from 18 to 70 years
MDS or AML with unfavorable genetics defined as follow
or more cytogenetic abnormalities or
cytogenetic abnormalities and TP53 or other unfavorable mutations (ASXL1, RUNX1) or
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 Criteria

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 mol/L
Liver enzyme > 3 N
Conjugated bilirubinemia > 25 mol/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
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