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

Launched by NANTES UNIVERSITY HOSPITAL · Jun 15, 2023

Keywords

ClinConnect Summary

This clinical trial is comparing two treatment regimens, Clofarabine and Fludarabine, to see which one helps adults with Acute Myeloid Leukemia (AML) do better after a specific type of stem cell transplant called allogeneic stem cell transplant (allo-SCT). The main goal is to find out if using Clofarabine can lead to better survival rates compared to Fludarabine for patients who are in remission from AML. The trial will involve 302 patients who meet specific criteria, such as being at least 18 years old, having AML in complete remission, and being eligible for a reduced-intensity conditioning regimen (usually for older adults or those with other health issues).

Participants in the trial will receive either Clofarabine or Fludarabine before their stem cell transplant, and they will be followed for two years after the transplant to monitor their health and quality of life. The study will also look at the costs associated with each treatment to determine which one is more cost-effective. It's important to note that women will need to use effective birth control during the study, and certain health conditions may exclude individuals from participating. This research is a step towards improving outcomes for patients with AML and may help establish better treatment options in the future.

Gender

ALL

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.