Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New drug combo aims to beat back leukemia relapse after transplant

NCT ID NCT05917405

Disease control Sponsor: Nantes University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether replacing fludarabine with clofarabine in the chemotherapy given before a stem cell transplant can help more adults with acute myeloid leukemia (AML) stay alive longer. About 302 patients whose AML is in remission will be randomly assigned to one of two reduced-intensity chemo regimens. The goal is to see if the clofarabine-based regimen improves two-year survival compared to the standard fludarabine-based regimen.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Clofarabine and Busulfan (compared to Fludarabine and Busulfan)
What this could lead to
If clofarabine works better, this could lead to a new standard pre-transplant regimen that lowers relapse risk and improves survival for AML patients.
What could go wrong
This is a mid-stage trial with 302 participants, so results are not yet proven. Clofarabine may cause more side effects, and the survival benefit may not hold up in larger studies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 302 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2023

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Acute myeloid leukemia in remission are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

acute myeloid leukemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute myeloid leukemia in remission

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    23 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • APHP Créteil

    RECRUITING

    Créteil, France

  • CHRU Lille

    NOT_YET_RECRUITING

    Lille, France

  • CHRU Nancy

    RECRUITING

    Nancy, France

  • CHU Amiens

    RECRUITING

    Amiens, France

  • CHU Angers

    RECRUITING

    Angers, France

  • CHU Besançon

    RECRUITING

    Besançon, France

  • CHU Bordeaux

    NOT_YET_RECRUITING

    Bordeaux, France

  • CHU Brest

    RECRUITING

    Brest, France

  • CHU Clermont-Ferrand

    RECRUITING

    Clermont-Ferrand, France

  • CHU Grenoble

    RECRUITING

    Grenoble, France

  • CHU Limoges

    RECRUITING

    Limoges, France

  • CHU Lyon

    RECRUITING

    Lyon, France

  • CHU Montpellier

    RECRUITING

    Montpellier, France

  • CHU Paris St-Louis

    RECRUITING

    Paris, France

  • CHU Poitiers

    NOT_YET_RECRUITING

    Poitiers, France

  • CHU Rennes

    RECRUITING

    Rennes, France

  • CHU St-Etienne

    RECRUITING

    Saint-Etienne, France

  • CHU de Nantes

    RECRUITING

    Nantes, Loire Atlantique, 44000, France

  • CRLC Caen

    RECRUITING

    Caen, France

  • CRLC Toulouse

    RECRUITING

    Toulouse, France

  • Institut Paoli Calmettes

    RECRUITING

    Marseille, France

  • Pitie-Salpetriere, APHP

    RECRUITING

    Paris, France

  • St-Antoine, APHP

    RECRUITING

    Paris, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.