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AzTrials

Acute Myeloid Leukemia in RemissionPhase 2FLUCLORICNCT05917405

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

A Phase 2 study testing Fludarabine, Busulfan and ATG in people with Acute Myeloid Leukemia in Remission, run by Nantes University Hospital at 23 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Acute Myeloid Leukemia in Remission
What is being tested?
Fludarabine, Busulfan and ATG
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
302 participants
Where
23 sitesFrance
Study dates
14 Sep 2023to 14 Sep 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 16Show fewer
  • 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.

Who cannot join

  • 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
Show all 15Show fewer
  • 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.

Trial locations and contacts

23 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Patrice CHEVALLIER, Pr contact

patrice.chevallier@chu-nantes.fr

MARION GAUTIER contact

+33253526204

marion.gautier@chu-nantes.fr

23 sites in 1 country

France23 sites, 23 recruiting

  • CHU Amiens

    Amiens

    Magalie JORIS, Dr, 032245466, joris.magalie@chu-amiens.fr

    Recruiting

  • CHU Angers

    Angers

    Sylvie FRANCOIS, Dr, 0241354472, Syfrancois@chu.angers.fr

    Recruiting

  • CHU Besançon

    Besançon

    Ana BERCEANU, Dr, 0381668232, aberceanu@chu-besancon.fr

    Recruiting

  • CHU Bordeaux

    Bordeaux

    Edouard FORCADE, Dr, 0557656511, Edouard.forcade@chu-bordeaux.fr

    Not yet recruiting

  • CHU Brest

    Brest

    Gaelle GUILLERM, Dr, 0298223395, Gaelle.guillerm@chu-brest.fr

    Recruiting

  • CRLC Caen

    Caen

    Sylvain CHANTEPIE, Dr, 0231272073, chantepie-s@chu-caen.fr

    Recruiting

  • CHU Clermont-Ferrand

    Clermont-Ferrand

    Jacques-Olivier BAY, Pr, 0473750750, jobay@chu-clermontferrand.fr

    Recruiting

  • APHP Créteil

    Créteil

    Florence BECKERICH, Pr, 0149812053, florence.beckerich@aphp.fr

    Recruiting

  • CHU Grenoble

    Grenoble

    Martin CARRE, Dr, 0476769445, MCarre@chu-grenoble.fr

    Recruiting

  • CHRU Lille

    Lille

    Valérie COITEUX, Dr, 0320445551, Valerie.coiteux@chu-lille.fr

    Not yet recruiting

  • CHU Limoges

    Limoges

    Pascal TURLURE, Dr, 0555056642, Pascal.turlure@chu-limoges.fr

    Recruiting

  • CHU Lyon

    Lyon

    Helene LABUSSIERE-WALLET, Dr, 0472117402, helene.labussiere-wallet@chu-lyon.fr

    Recruiting

  • Institut Paoli Calmettes

    Marseille

    Raynier DEVILLIER, Dr, 0491223868, DEVILLIER@ipc.unicancer.fr

    Recruiting

  • CHU Montpellier

    Montpellier

    Patrice CEBALLOS, Dr, 0467338079, p-ceballos@chu-montpellier.fr

    Recruiting

  • CHRU Nancy

    Nancy

    Marie-Therese RUBIO, Pr, 0383153030, M.RUBIO@chru-nancy.fr

    Recruiting

  • CHU de Nantes

    Nantes, Loire Atlantique, 44000

    Patrice Chevallier, Pr, 0240083271, patrice.chevallier@chu-nantes.fr

    Recruiting

  • CHU Paris St-Louis

    Paris

    Marie ROBIN, Dr, 0142499639, marie.robin@aphp.fr

    Recruiting

  • Pitie-Salpetriere, APHP

    Paris

    Stéphanie NGUYEN, Pr, 0142162823, stephanie.nguyen-quoc@aphp.fr

    Recruiting

  • St-Antoine, APHP

    Paris

    Mohamad MOHTY, Pr, 0149282620, Mohamad.mohty@inserm.fr

    Recruiting

  • CHU Poitiers

    Poitiers

    Natacha MAILLARD, Dr, 0549444472, natacha.maillard@chu-poitiers.fr

    Not yet recruiting

  • CHU Rennes

    Rennes

    Jean-Baptiste MEAR, Dr, 0299284291, jeanbaptiste.mear@chu-rennes.fr

    Recruiting

  • CHU St-Etienne

    Saint-Etienne

    Jerome CORNILLON, Dr, 0477917000, Jerome.Cornillon@icloire.fr

    Recruiting

  • CRLC Toulouse

    Toulouse

    Anne HUYNH, Dr, 0531155527, huynh.anne@iuct-oncopole.fr

    Recruiting

Other trials in France

About this study

Official title: FLUCLORIC: 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

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.

Being tested
Fludarabine, Busulfan, ATG, Clofarabine
Keywords
Acute Myeloid Leukemia, Clofarabine, fludarabine, reduced intensity conditioning regimen, allogeneic stem cells transplantation
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FludarabineDrug

    30 mg/m2/day IV fludarabine for 5 days (day-6 to day-2)

  • BusulfanDrug

    130 mg/m2/day IV busulfan once daily for 2 days (day -4 and -3)

  • ATGDrug

    Thymoglobuline®: 2.5 mg/Kg/day IV for 2 consecutive days (day -2 and -1)

  • ClofarabineDrug

    30 mg/m2/day IV clofarabine for 5 days (day-6 to day-2)

Study groups in NCT05917405
Study groupRoleWhat they receive
Experimental: CloB2 armExperimental* 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
Receives: Drug: Busulfan; Drug: ATG; Drug: Clofarabine
Comparator: FB2A2 armActive 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)
Receives: Drug: Fludarabine; Drug: Busulfan; Drug: ATG

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To compare 2-year OS between patients with AML in complete remission receiving either a CloB2A2 or a FB2A2 RIC regimen for allo-SCT.

    OS is defined as the time from day 1 of conditioning to death or last follow-up for survivors.

    Measured: 2 years

Secondary outcomes (23)

  1. To compare between AML patients in complete remission receiving either a CloB2A2 or a FB2A2 RIC regimen for allo-SCT: Engraftment, primary and secondary graft failure

    • Engraftment: PNN >500/mm3 + donor chimerism >=5% (day +30/42)
    • Primary and secondary graft failure: donor chimerism <5% at day +30/42 post-transplant (primary) or at distance of transplant after achieving engraftment (secondary)

    Measured: day +30/42 and 2 years

  2. To compare between AML patients in complete remission receiving either a CloB2A2 or a FB2A2 RIC regimen for allo-SCT: Neutrophils and platelet recoveries

    • Neutrophils recovery: the first of three consecutive days with neutrophils ≥500/mm3 after aplasia from day 0 of the graft
    • Platelets recovery: the first of three consecutive days with platelets ≥20000/mm3 without transfusion after aplasia from day 0 of the graft

    Measured: 2 years

  3. To compare between AML patients in complete remission receiving either a CloB2A2 or a FB2A2 RIC regimen for allo-SCT: 2-year DFS

    DFS: time from day1 of the conditioning to time without death or evidence of relapse or disease progression censored at the date of last follow-up.

    Measured: 2 years

  4. To compare between AML patients in complete remission receiving either a CloB2A2 or a FB2A2 RIC regimen for allo-SCT:-2-year relapse incidence

    Relapse: any event related to progression or re-occurrence of the disease from day 1 of the conditioning.

    Measured: 2 years

  5. To compare between AML patients in complete remission receiving either a CloB2A2 or a FB2A2 RIC regimen for allo-SCT:2-year NRM

    NRM: death from any cause without previous relapse or progression from day 1 of the conditioning

    Measured: 2 years

  6. To compare between AML patients in complete remission receiving either a CloB2A2 or a FB2A2 RIC regimen for allo-SCT:Incidence of acute and chronic graft versus host disease (GVHD)

    • Acute GVHD: NIH criteria
    • Chronic GVHD: NIH criteria

    Measured: Day 90 and 2 years

  7. To compare between AML patients in complete remission receiving either a CloB2A2 or a FB2A2 RIC regimen for allo-SCT:Incidence of GVHD free relapse free survival (GRFS)

    GRFS: alive with no previous grade III-IV acute GvHD, no moderate or severe chronic GvHD and no relapse from day 1 of the conditioning

    Measured: 2 years

  8. To compare between AML patients in complete remission receiving either a CloB2A2 or a FB2A2 RIC regimen for allo SCT:Chimerism

    Chimerism: peripheral blood and CD3 T cells by molecular markers at days +30, +60, +90/100

    Measured: days +30, +60, +90

  9. To compare between AML patients in complete remission receiving either a CloB2A2 or a FB2A2 RIC regimen for allo- SCT:Immune reconstitution

    Immune reconstitution: Immunophenotype of PB lymphocytes and EPP: CD4, CD8, B, NK, EPP at 3, 6 and 12 months

    Measured: 3, 6 and 12 months

  10. To compare between AML patients in complete remission receiving either a CloB2A2 or a FB2A2 RIC regimen for allo- SCT: Minimal residual disease (MRD)

    Minimal residual disease (MRD): before transplant, at day +30 and day +90/100 by flow cytometry, molecular biology and NGS (if available) (ELN 2022 recommendation, Dohner et al Blood 2022)

    Measured: days +30 and +90

  11. Comparison of infections after FB2A2 vs CloB2A2: bacterial, viral, parasitic and fungal

    Comparison of infections after FB2A2 vs CloB2A2: bacterial, viral, parasitic and fungal between day 0 and day+90/100

    Measured: day+90

  12. Quality of life using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30)

    Score of the QLQ-C30 questionnaire, including 30 questions assessing some aspects of the quality of life of cancer patients. The total score ranges from 0 to 100.

    Measured: Days -7, +30, +90, +180, +360 and +720

  13. Quality of life using the and FACT-BMT (Functional Assessment of Cancer Therapy - Bone Marrow Transplant))

    Score of the FACT-BMT questionnaire, including 50 questions assessing some aspects of the quality of life of cancer patients. The total score ranges from 0 to 200.

    Measured: Days -7, +30, +90, +180 and +360

  14. comparison of the cost of graft hospitalization between the 2 arms

    Graft hospitalization cost: Comparison between both groups in terms of length of stay (in days), use of antibiotics (type and length in days)

    Measured: 2 years

  15. comparison of the cost of graft hospitalization between the 2 arms

    Graft hospitalization cost: Comparison between both groups in terms of blood products administered (numbers)

    Measured: 2 years

  16. health benefit measurement in both treatment arms

    General Health State with Euroqol EQ-5D-5L questionnaire at Days -7, 30, 90, 180, 360 and 720; 5 answers are possible.

    Measured: Days -7, +30, +90, +180, +360 and +720.

  17. Evaluation of economic efficiency of a CloB2A2 compared to a FB2A2 RIC regimen for allo-SCT, from a collective perspective (considering costs to the National Health Insurance system, hospital and patients)with a 24-month time horizon.

    Health Economic study: Incremental cost-utility ratio (ICUR, cost per quality-adjusted life year [QALY] gained) and incremental cost-effectiveness ratio (ICER, cost per life year gained), from a collective perspective and with a 24-month time horizon

    Measured: 2 years

  18. Comparison of Overall survival (OS) between patients in first vs second line therapy and impact of clofarabine vs fludarabine in each sub-group.

    Comparison of time from D1 of conditioning to death or last follow-up for survivors

    Measured: 2 years

  19. Comparison of DFS between patients in first vs second line therapy and impact of clofarabine vs fludarabine in each sub-group.

    Comparison of time from day1 of the conditioning to time without death or evidence of relapse or disease progression censored at the date of last follow-up.

    Measured: 2 years

  20. Comparison of Overall survival (OS) between patients receiving a first vs a second allograft and impact of clofarabine vs fludarabine in each sub-group.

    Comparison of time from D1 of conditioning to death or last follow-up for survivors

    Measured: 2 years

  21. Comparison of DFS between patients receiving a first vs a second allograft and impact of clofarabine vs fludarabine in each sub-group.

    Comparison of time from day1 of the conditioning to time without death or evidence of relapse or disease progression censored at the date of last follow-up.

    Measured: 2 years

  22. Comparison of occurence of Veno-occlusive disease between patients receiving clofarabine vs fludarabine.n day 0 and day+90/100

    Comparison of occurrence of veno-occlusive disease : (Mohty et al, BMT 2016) betwee

    Measured: day+90

  23. Safety assessment

    Safety assessment: the safety assessment shall be done by collecting all adverse events that occur during the research. All adverse event (except GvHD) shall be graded according to CTC-AE Toxicity Grading Scale (version 5).

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2023
  2. Study start14 Sep 2023
  3. Primary completion14 Sep 2028 (estimated)
  4. Study completion14 Sep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
302 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05917405
Sponsor's protocol ID
RC22_0524
Acronym
FLUCLORIC
Status last verified
Jan 2026
First submitted
16 May 2023
Last updated
30 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Fludarabine, Busulfan and ATG in people with Acute Myeloid Leukemia in Remission, run by Nantes University Hospital at 23 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Patrice CHEVALLIER, Pr (patrice.chevallier@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To compare 2-year OS between patients with AML in complete remission receiving either a CloB2A2 or a FB2A2 RIC regimen for allo-SCT. (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05917405.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.

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