Study Comparing the Efficacy of 2 RIC Regimens (Clofarabine vs Fludarabine) in Adults With AML Eligible to Allo-SCT (FLUCLORIC)
Acute Myeloid Leukemia in Remission
About this trial
This is an interventional treatment trial for Acute Myeloid Leukemia in Remission focused on measuring Acute Myeloid Leukemia, Clofarabine, fludarabine, reduced intensity conditioning regimen, allogeneic stem cells transplantation
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%) 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). Patient with a related or an unrelated matched donor Graft using only peripheral blood stem cells Performance status ECOG 0 - 2 Who provide their written informed consent Previous allograft allowed Affiliated with French social security system or beneficiary from such system Women must meet one of the following criteria at the time of inclusion: use adequate contraceptive measures as recommended by the CTFG (Recommendations related to contraception and pregnancy testing in clinical trials v1.1; includes injectable implants, dual hormone birth control pills, intrauterine devices, abstinence from sex, or a sterilized partner), and have a negative pregnancy test (urine or serum pregnancy test) prior to receiving the first dose of study drug; or be post-menopausal (over 50 years of age with amenorrhea for at least 12 months after discontinuation of all exogenous hormonal therapy) or (if under 50 years of age) have been amenorrheic for at least 12 months after discontinuation of exogenous hormonal therapy and with luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels corresponding to post-menopausal levels or have undergone irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy (this operation must be documented). Contraception methods must be prescribed using effective contraceptive methods during treatment and within 6 months for women of childbearing age (WOCB) and 6 months for men in case they have sexual relations with WOCB after the last dose of Fludarabine/Clofarabine. Exclusion Criteria: Pro-myelocytic leukemia Patient eligible to a myeloablative conditioning regimen Patient with haploidentical, mismatched unrelated donor or umbilical cord blood Pregnant or breastfeeding woman or patient refusing contraceptive mesures HIV positive Active Hepatitis B or C Left ventricular ejection fraction < 50%. DLCO <40% Uncontrolled infection Uncontrolled haemolytic anaemia Creatinine clearance < 50 ml/min (evaluated by MDRD or CKDEPI). Serum bilirubine < 30 mmol/l, Cytolysis >5 the upper limit range Previous or concurrent second malignancy except for adequately treated basal cell carcinoma of the skin, curatively treated in situ carcinoma of the cervix, curatively treated solid cancer, with no evidence of disease for at least 2 years Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule Participation to another interventional study during the last month or expected participation to another interventional study during participation to the FLUCLORIC study.
Sites / Locations
- CHU de Nantes
- CHU Amiens
- CHU Angers
- CHU Besançon
- CHU Bordeaux
- CHU Brest
- CRLC Caen
- CHU Clermont-Ferrand
- APHP Créteil
- CHU Grenoble
- CHRU Lille
- CHU Limoges
- CHU Lyon
- Institut Paoli Calmettes
- CHU Montpellier
- CHRU Nancy
- CHU Paris St-Louis
- Pitie-Salpetriere, APHP
- St-Antoine, APHP
- CHU Poitiers
- CHU Rennes
- CHU St-Etienne
- CRLC Toulouse
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Experimental: CloB2 arm
Comparator: FB2A2 arm
30 mg/m2/day IV clofarabine for 5 days (day-6 to day-2) 130 mg/m2/day IV busulfan once daily for 2 days (day -4 and -3) ATG (Thymoglobuline®) 2.5 mg/Kg/day IV for 2 consecutive days (day -2 and -1) Corticosteroids may be used in profilaxis
30 mg/m2/day IV fludarabine for 5 days (day-6 to day-2) 130 mg/m2/day IV busulfan once daily for 2 days (day -4 and -3) ATG (Thymoglobuline®) 2.5 mg/Kg/day IV for 2 consecutive days (day -2 and -1)