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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04857645
Other study ID # GFM-DACORAL-DLI
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date June 22, 2021
Est. completion date April 2025

Study information

Verified date September 2023
Source Groupe Francophone des Myelodysplasies
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 57
Est. completion date April 2025
Est. primary completion date April 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - 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 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 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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
France CHU d'Amiens Picardie - Site sud - Service hématologie clinique et thérapie cellulaire Amiens
France CHU d'Angers - Service des maladies du sang Angers
France CHU Estaing - Service hématologie clinique et thérapie cellulaire Clermont-Ferrand
France CHU de Grenoble - Clinique Universitaire d'hématologie Grenoble
France CHRU de Limoges - Hôpital Dupuytren - Service hématologie clinique et thérapie cellulaire Limoges
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 CHU de Haut-Lévèque de Bordeaux - Service des maladies du sang Pessac
France CH Lyon Sud - Servide Hématologie Pierre-Bénite
France Centre Henri Becquerel - Département d'hématologie Rouen
France Institut de Cancérologie Lucien Neuwirth - Hématologie clinique et thérapie cellulaire Saint-Priest-en-Jarez
France IUCT Oncopole - Département d'hématologie - Service de greffe de cellules souches hématopoïétiques Toulouse
France CHU Brabois - Service hématologie clinique Vandœuvre-lès-Nancy

Sponsors (2)

Lead Sponsor Collaborator
Groupe Francophone des Myelodysplasies Astex Pharmaceuticals, Inc.

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Disease free Survival (DFS) at one year post transplant Measure of time during which no sign of progression is found 1 year post transplant
Secondary Overall Survival (OS) at one year post transplant Measure of time from randomization to death from any cause 1 year post transplant
Secondary Overall Survival (OS) at two years post transplant Measure of time from randomization to death from any cause 2 years post transplant
Secondary Risk factors for DFS, OS and non-relapse mortality at 1 and 2 years Statistical study of cumulative incidence curves 1 and 2 years
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