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FLUCLORICClofarabine/Busulfan vs Fludarabine/Busulfan in Adult AML Patients Eligible for Allogeneic Stem Cell Transplantation

Study Aim

This study aims to compare the two-year overall survival rate between adult AML patients in complete remission who receive either a Clofarabine/Busulfan or a Fludarabine/Busulfan reduced-intensity conditioning regimen for allogeneic stem cell transplantation.

What is being tested

Fludarabine

+ Busulfan

+ ATG

Drug

Who is being recruted

Hematologic Diseases+4

+ Hemic and Lymphatic Diseases

+ Leukemia

From 18 to 99 Years

+16 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2

Interventional

Study Start: September 2023

See protocol details

Summary

Principal SponsorNantes University Hospital

Study ContactPatrice CHEVALLIER, PrMore contacts

Last updated: January 31, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: September 14, 2023

Actual date on which the first participant was enrolled.

This study focuses on adults with Acute Myeloid Leukemia (AML) who are eligible for a stem cell transplant. The main goal is to compare the effectiveness of two different reduced-intensity conditioning regimens, Clofarabine/Busulfan and Fludarabine/Busulfan, which are used before the transplant. These regimens are designed to decrease the risk of relapse, a major cause of death in patients with AML. The study aims to establish Clofarabine/Busulfan as a superior regimen if it can significantly improve the two-year overall survival rate compared to Fludarabine/Busulfan. The study involves 302 AML patients in complete remission at the time of transplant, with 151 patients in each group. Participants will receive one of the two conditioning regimens before their stem cell transplant. The primary outcome measured is the two-year overall survival rate, defined as the time from the first day of conditioning to either death or the last follow-up for survivors. The study will also assess the quality of life after transplant and perform a cost-utility and cost-effectiveness analysis. The total duration of the study is five years, with three years for patient inclusion and two years of follow-up for each patient.

Official TitleFLUCLORIC: Randomized Multicentric Phase III Study Comparing the Efficacy of 2 Reduced Intensity Conditioning Regimens (Clofarabine/Busulfan vs Fludarabine/Busulfan) in Adults With AML and Eligible to Allogeneic Stem Cell Transplantation

NCT05917405

Principal SponsorNantes University Hospital

Study ContactPatrice CHEVALLIER, PrMore contacts

Last updated: January 31, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

302 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 99 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Hematologic DiseasesHemic and Lymphatic DiseasesLeukemiaLeukemia, MyeloidNeoplasmsNeoplasms by Histologic TypeLeukemia, Myeloid, Acute

Criteria

6 inclusion criteria required to participate

Patients in first or second line therapy are allowed

Age ≥ 18 years' old

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

Show More Criteria

10 exclusion criteria prevent from participating

DLCOc <40%

Patient eligible to a myeloablative conditioning regimen

Patient with haploidentical, mismatched unrelated donor or umbilical cord blood

Left ventricular ejection fraction < 50%.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Active Comparator

* 30 mg/m2/day IV fludarabine for 5 days (day-6 to day-2) * 3.2 mg/kg/day IV busulfan once daily for 2 days (day -5 and -4) * ATG (Thymoglobuline®) 2.5 mg/Kg/day IV for 2 consecutive days (day -2 and -1)

Group II

Experimental

* 30 mg/m2/day IV clofarabine for 5 days (day-6 to day-2) * 3.2mg/kg/day IV busulfan once daily for 2 days (day -5 and -4) * ATG (Thymoglobuline®) 2.5 mg/Kg/day IV for 2 consecutive days (day -2 and -1) Corticosteroids may be used in profilaxis

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 23 locations

Recruiting

CHU de Nantes

Nantes, FranceOpen CHU de Nantes in Google Maps

Recruiting

CHU Amiens

Amiens, France

Recruiting

CHU Angers

Angers, France

Recruiting

CHU Besançon

Besançon, France

Recruiting

23 Study Centers