Actively Recruiting
Study Comparing the Efficacy of 2 RIC Regimens (Clofarabine vs Fludarabine) in Adults With AML Eligible to Allo-SCT
Led by Nantes University Hospital · Updated on 2026-01-30
302
Participants Needed
23
Research Sites
261 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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) regimen compared to the FB2A2 for AML patients.302 AML patients (151 in each arm) in complete remission at transplant will be included with the main objective to demonstrate a significant better 2-year overall survival for CloB2A2 cases (70% vs 55%). A cost-utility analysis and a cost-effectiveness analysis will be also performed as well as an assessment of the quality of life after transplant. Clofarabine will be furnished to all centers. The duration of the study will be 5 years with 3 years of inclusion and 2 years of follow-up for each patient.
CONDITIONS
Official Title
Study Comparing the Efficacy of 2 RIC Regimens (Clofarabine vs Fludarabine) in Adults With AML Eligible to Allo-SCT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis of de novo or secondary AML in complete cytological remission with bone marrow blast count less than 5%, or MDS/AML with blast count 5% or less
- Patients in first or second line therapy allowed
- Eligibility for reduced-intensity conditioning regimen: age 60 or older, or under 60 with co-morbidities
- Availability of related or unrelated matched donor
- Use of peripheral blood stem cells for graft
- ECOG performance status 0 to 2
- Written informed consent provided
- Previous allogeneic transplant allowed
- Affiliation with French social security system or beneficiary status
- Women must meet contraception requirements or be postmenopausal or surgically sterilized
You will not qualify if you...
- Diagnosis of pro-myelocytic leukemia
- Eligibility for myeloablative conditioning regimen
- Haploidentical, mismatched unrelated donor, or umbilical cord blood donor
- Pregnant or breastfeeding women or refusal of contraception
- HIV positive status
- Active Hepatitis B or C infection
- Left ventricular ejection fraction less than 50%
- DLCOc less than 40%
- Uncontrolled infection
- Uncontrolled hemolytic anemia
- Creatinine clearance less than 50 ml/min
- Serum bilirubin above 30 mmol/l or cytolysis more than 5 times the upper limit
- Previous or concurrent second malignancy except certain treated cancers with no evidence for 2 years
- Psychological, familial, sociological, or geographical conditions interfering with protocol compliance
- Participation in another interventional study within last month or planned during this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 23 locations
1
CHU de Nantes
Nantes, Loire Atlantique, France, 44000
Actively Recruiting
2
CHU Amiens
Amiens, France
Actively Recruiting
3
CHU Angers
Angers, France
Actively Recruiting
4
CHU Besançon
Besançon, France
Actively Recruiting
5
CHU Bordeaux
Bordeaux, France
Not Yet Recruiting
6
CHU Brest
Brest, France
Actively Recruiting
7
CRLC Caen
Caen, France
Actively Recruiting
8
CHU Clermont-Ferrand
Clermont-Ferrand, France
Actively Recruiting
9
APHP Créteil
Créteil, France
Actively Recruiting
10
CHU Grenoble
Grenoble, France
Actively Recruiting
11
CHRU Lille
Lille, France
Not Yet Recruiting
12
CHU Limoges
Limoges, France
Actively Recruiting
13
CHU Lyon
Lyon, France
Actively Recruiting
14
Institut Paoli Calmettes
Marseille, France
Actively Recruiting
15
CHU Montpellier
Montpellier, France
Actively Recruiting
16
CHRU Nancy
Nancy, France
Actively Recruiting
17
CHU Paris St-Louis
Paris, France
Actively Recruiting
18
Pitie-Salpetriere, APHP
Paris, France
Actively Recruiting
19
St-Antoine, APHP
Paris, France
Actively Recruiting
20
CHU Poitiers
Poitiers, France
Not Yet Recruiting
21
CHU Rennes
Rennes, France
Actively Recruiting
22
CHU St-Etienne
Saint-Etienne, France
Actively Recruiting
23
CRLC Toulouse
Toulouse, France
Actively Recruiting
Research Team
P
Patrice CHEVALLIER, Pr
CONTACT
M
MARION GAUTIER
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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