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

Sponsor
Groupe Francophone des Myelodysplasies (Other)
Overall Status
Recruiting
CT.gov ID
NCT04857645
Collaborator
Astex Pharmaceuticals, Inc. (Industry)
40
Enrollment
16
Locations
1
Arm
42.3
Anticipated Duration (Months)
2.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
Phase 2

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Prospective Study "GFM-DACORAL-DLI" ASTX727 and Donor Lymphocyte Infusions After Allogenic Stem Cell Transplantation in Very High Risk MDS or AML Patients
Actual Study Start Date :
Jun 22, 2021
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Jan 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: ASTX727 treatment

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
Other Names:
  • DLI

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Overall Survival (OS) at one year post transplant [1 year post transplant]

      Measure of time from randomization to death from any cause

    2. Overall Survival (OS) at two years post transplant [2 years post transplant]

      Measure of time from randomization to death from any cause

    3. Risk factors for DFS, OS and non-relapse mortality at 1 and 2 years [1 and 2 years]

      Statistical study of cumulative incidence curves

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    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
    5 CHRU de Limoges - Hôpital Dupuytren - Service hématologie clinique et thérapie cellulaire Limoges France 87042
    6 Hôpital Saint Eloi - Service hématologie clinique Montpellier France 34295
    7 CHU Hôtel Dieu - Service hématologie clinique Nantes France 44093
    8 Hôpital Saint Louis - Service hématologie-greffe Paris France 75010
    9 Hôpital Pitié-Salpêtrière - Service hématologie clinique Paris France 75013
    10 Hôpital Necker - Service hématologie adulte Paris France 75015
    11 CHU de Haut-Lévèque de Bordeaux - Service des maladies du sang Pessac France 33604
    12 CH Lyon Sud - Servide Hématologie Pierre-Bénite France 69645
    13 Centre Henri Becquerel - Département d'hématologie Rouen France 76038
    14 Institut de Cancérologie Lucien Neuwirth - Hématologie clinique et thérapie cellulaire Saint-Priest-en-Jarez France 42270
    15 IUCT Oncopole - Département d'hématologie - Service de greffe de cellules souches hématopoïétiques Toulouse France 31059
    16 CHU Brabois - Service hématologie clinique Vandœuvre-lès-Nancy France 54511

    Sponsors and Collaborators

    • Groupe Francophone des Myelodysplasies
    • Astex Pharmaceuticals, Inc.

    Investigators

    • Principal Investigator: Marie ROBIN, MD, Hôpital Saint Louis - Service hématologie-greffe
    • Principal Investigator: Pierre FENAUX, MD, Hôpital Saint Louis - Service hématologie séniors

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Groupe Francophone des Myelodysplasies
    ClinicalTrials.gov Identifier:
    NCT04857645
    Other Study ID Numbers:
    • GFM-DACORAL-DLI
    First Posted:
    Apr 23, 2021
    Last Update Posted:
    Jul 22, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Groupe Francophone des Myelodysplasies
    Very high risk MDS
    AML
    ASTX727
    DLI

    Study Results

    No Results Posted as of Jul 22, 2022