Study to Improve OS in 18 to 60 Year-old Patients, Comparing Daunorubicin Versus High Dose Idarubicin Induction Regimens, High Dose Versus Intermediate Dose Cytarabine Consolidation Regimens, and Standard Versus MMF Prophylaxis of GvHD in Allografted Patients in First CR

This open label, multicenter phase II/III study with multiple randomization phases at differents stages of AML treatment (induction, consolidation and HSCT where applicable) is designed to improve OS in younger (18 to 60 year-old) patients, with AML risk-adapted patient strategies. Within the intermediate risk AML group, optimal GvHD prophylaxis following allogeneic SCT in first CR, after either myeloablative (MAC) or reduced intensity (RIC) conditioning, will also be evaluated. With an adaptative design, this clinical trial could test up to 3 novel AML agents of interest.

Trial Details

NCT ID
NCT02416388
Phase
PHASE2 / PHASE3
Sponsor
University Hospital, Angers
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Idarubicin
  • Daunorubicin
  • HD Cytarabine
  • Cyclosporine
  • Methotrexate
  • Mycophenolic acid (MPA)
Locations (sample)
  • Amiens, France|49.9,2.3
  • Angers, France|47.47156,-0.55202
  • Argenteuil, France|48.94788,2.24744
  • Bayonne, France|43.49316,-1.473
  • Besançon, France|47.24878,6.01815

Key Eligibility Criteria

  • Age ≥ 18 years and \< 61 years
  • With a newly diagnosed de novo or secondary type AML (post myelodysplastic syndrome MDS or therapy-related AML)
  • No prior treatment for neither AML (with the exception of hydroxyurea), nor MDS (with the exception of EPO)
  • ECOG performance status ≤ 3

For full eligibility, visit ClinicalTrials.gov.

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