Comparing two treatment regimens for adults with acute myeloid leukemia before stem cell transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to compare the efficacy of two reduced-intensity conditioning regimens, Clofarabine and Fludarabine, in adults with acute myeloid leukemia (AML) who are in complete remission and eligible for allogeneic stem cell transplantation. The trial will include 302 patients, with the primary objective of demonstrating a significant improvement in 2-year overall survival rates for those receiving the Clofarabine regimen. Additionally, the study will conduct cost-utility and cost-effectiveness analyses, as well as assess the quality of life post-transplant. The results will help establish the superiority of CloB2A2 over FB2A2 in this patient population.

Why it matters

Who can join: the full rules

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
* 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%.
* DLCOc \<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.

Where it's running

• CHU de Nantes
  Nantes, Loire Atlantique, France Recruiting
• CHU Amiens
  Amiens, France Recruiting
• CHU Angers
  Angers, France Recruiting
• CHU Besançon
  Besançon, France Recruiting
• CHU Brest
  Brest, France Recruiting
• CRLC Caen
  Caen, France Recruiting

Study contacts

• Principal investigator: patrice CHEVALLIER, Pr — Nantes University Hospital
• Study coordinator: Patrice CHEVALLIER, Pr
• Email: patrice.chevallier@chu-nantes.fr

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.