Study Comparing the Efficacy of 2 RIC Regimens (Clofarabine vs Fludarabine) in Adults With AML Eligible to Allo-SCT

Relapse remains the main cause of death in patients with myeloid malignancies, especially after an allotransplant. Using drugs with higher anti-leukemic activity as part of the conditioning regimen is one of the strategies to decrease relapse incidence in this population. Retrospective studies have shown that clofarabine can achieve impressive results compared to the use of fludarabine in acute myeloid leukemia (AML) as part of the conditioning regimen. Confirming such results in a prospective manner would definitely establish the CloB2A2 as a superior reduced-intensity conditioning (RIC) regi

Trial Details

NCT ID
NCT05917405
Phase
PHASE2
Sponsor
Nantes University Hospital
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Fludarabine
  • Busulfan
  • ATG
  • Clofarabine
Locations (sample)
  • Nantes, Loire Atlantique, France|47.21725,-1.55336
  • Amiens, France|49.9,2.3
  • Angers, France|47.47156,-0.55202
  • Besançon, France|47.24878,6.01815
  • Bordeaux, France|44.84124,-0.58046

Key Eligibility Criteria

  • Age ≥ 18 years' old
  • De novo or secondary AML (according to ELN 2022 classification) in complete cytological remission at time of transplant (bone marrow blast count \<…
  • Patients in first or second line therapy are allowed
  • Patient eligible to a RIC regimen : patients aged ≥ 60 year old or \<60 with co-morbidity(ies).

For full eligibility, visit ClinicalTrials.gov.

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