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Completed

NCT Number: NCT04857645

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

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

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Key information

Conditions

MDS AML

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHU d'Amiens Picardie - Site sud - Service hématologie clinique et thérapie cellulaire, Amiens, France

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ASTX727

Drug

Eligible patient started ASTX727 between 40 and 130 days after allogenic stem cell transplantation

Donor Lymphocyte Infusions

Other

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

Primary outcomes

  1. Disease free Survival (DFS) at one year post transplant

    Time frame: 1 year post transplant

    Measure of time during which no sign of progression is found

Secondary outcomes

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

    Time frame: 1 year post transplant

    Measure of time from randomization to death from any cause

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

    Time frame: 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

    Time frame: 1 and 2 years

    Statistical study of cumulative incidence curves

Sponsors and collaborators

Lead sponsor

Groupe Francophone des Myelodysplasies

Other

Collaborators

  • Astex Pharmaceuticals, Inc.

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Apr 23, 2021
Registry last updated
May 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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