Study Comparing the Efficacy of 2 RIC Regimens (Clofarabine vs Fludarabine) in Adults With AML Eligible to Allo-SCT
Recruiting
Phase 2
Interventional Study
Acute Myeloid Leukemia in Remission
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 99
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 302 (estimated)
- Sponsor
- Nantes University Hospital · Other
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About This Trial
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 my…
Trial Locations
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Eligibility Criteria
Inclusion 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 \< 5%) or MDS/LAM with bone marrow blast count ≤ 5%
* Patients in first or second line therapy are allowed
* Pa…
Contacts