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New chemo cocktail aims to beat back leukemia relapse

NCT ID NCT00932412

Disease control Sponsor: Hospices Civils de Lyon Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tests whether a combination of clofarabine and intermediate-dose cytarabine (CLARA) works better than high-dose cytarabine (HDAC) alone as consolidation therapy for younger adults (18-60) with newly diagnosed acute myeloid leukemia (AML). After initial remission, 735 participants were randomized to receive three cycles of either CLARA or HDAC. The main goal is to see which regimen leads to longer disease-free survival.

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 cytarabine (CLARA) vs high-dose cytarabine (HDAC)
What this could lead to
If CLARA works better, it could offer a more effective consolidation option for younger AML patients, potentially reducing relapse risk.
What could go wrong
This is a phase 2 trial, so results are preliminary. The CLARA combo may not improve outcomes over standard HDAC and could have different side effects.

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

735 people

The number who actually took part.

Start date

Mar 2009

Finished

Apr 2016

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 60 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 at registration: 1. Age 18 years or more and less than 60 years 2. With: A morphologically proven diagnosis of AML according to the WHO classification, cytogenetically (standard karyotype, FISH-MLL) and molecularly (FLT3, CEBPA, NMP1) defined. 3. ECOG (Eastern Cooperative Oncology Group) performance status 0 to 2. 4. Have adequate renal and hepatic function as indicated by the following laboratory values: * Creatinine clearance (calculated by the cockcroft and Gault method) ≥ 40mL/min; * AST (Aspartate amino transférase) and ALT (Alanine Amino Transférase ) \< or = 2.5N; total bilirubin \< or = 2N (unless related to the underlying disease). 5. Cardiac function determined by radionuclide or echography within normal limits. 6. Women of child-bearing potential (i.e. women who are pre-menopausal or not surgically sterile) must use acceptable contraceptive methods, and must have a negative serum or urine pregnancy test within 2 weeks prior the beginning treatment on this trial. 7. Must be able and willing to give written informed consent. 8. The subject must be covered by a social security system. Exclusion Criteria at registration: 1. Patients with AML with favorable risk cytogenetics: M3-AML; CBF-AML including t(8:21), inv(16), or t(16;16) AML. 2. Ph-positive AML. 3. AML following diagnosed myeloproliferation or patient with prior history of MDS known for more than 3 months 4. Prior treatment with chemotherapy or radiotherapy for another tumor. 5. Prior tumor, if not stable for at least two years, except in-situ carcinoma and skin carcinoma 6. Compromised organ function judged to be lifethreatening by the Investigator. 7. Positive serology for HIV (Human Immunodeficiency Virus), HBV (Hepatitis B Virus) and HBC (Hepatitis C Virus)(except post vaccination) 8. Uncontrolled active infection of any kind or bleeding. Patients with infections who are under active treatment with antibiotics and whose infections are controlled may be entered to the study. 9. Other active malignancy. 10. Patients concurrently receiving any other standard or investigational treatment for their leukemia, with the exception of hydroxyurea. INCLUSION CRITERIA AT RANDOMIZATION 1. Patients with either in first CR/CRp after the first induction course or in first CR/CRp after salvage therapy. 2. ECOG performance status 0 to 2. 3. AST and ALT \< or = 2.5N; total bilirubin \< or = 2N. 4. Creatinine clearance ≥40mL/min (calculated by the cockcroft and Gault method or by MDRD (see http://nephron.org/cgi-bin/MDRD\_GFR/cgi) 5. Patient without HLA identical donor. EXCLUSION CRITERIA AT RANDOMIZATION 6. Patients belonging to the intermediate 1 risk group (CEBPA+ or NPM1+ without Flt3-ITD) in CR/CRp after the first induction course. These patients will go out of the study and receive consolidation cycles based on HD-AraC (Aracytine). 7. Known central nervous system involvement with AML. 8. Uncontrolled active infection of any kind or bleeding. 9. Compromized organ function judged to be lifethreatening by the Investigator. 10. Patient with HLA identical donor identified.

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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

Contacts and locations

Locations

  • CHU - Hôtel Dieu

    Nantes, 44093, France

  • CHU Dupuytren

    Limoges, 87042, France

  • CHU de Brabois

    Vandœuvre-lès-Nancy, 54511, France

  • Centre A. Lacassagne

    Nice, 06100, France

  • Centre Henri Becquerel - CHRU ROUEN

    Rouen, 76038, France

  • Centre Hospitalier Boulogne/Mer

    Boulogne-sur-Mer, 62280, France

  • Centre Hospitalier Dunkerque

    Dunkirk, 59395, France

  • Centre Hospitalier Huguenin

    Saint-Cloud, 92210, France

  • Centre Hospitalier Meaux

    Meaux, 77104, France

  • Centre Hospitalier Regional et Universitaire d'Angers

    Angers, 49033, France

  • Centre Hospitalier René Dubos

    Cergy-Pontoise, 95303, France

  • Centre Hospitalier Schaffner

    Lens, 62307, France

  • Centre Hospitalier Valenciennes

    Valenciennes, 59322, France

  • Centre Hospitalier Versailles

    Le Chesnay, 78150, France

  • HIA Percy

    Clamart, 92141, France

  • Hospices Civils de Lyon - Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495, France

  • Hôpital Archet 1

    Nice, 06202, France

  • Hôpital Avicenne - bobigny

    Bobigny, 93009, France

  • Hôpital Clemenceau - chu Caen

    Caen, 14033, France

  • Hôpital Dubocage

    Dijon, 21000, France

  • Hôpital Haut Lévêque

    Pessac, 33604, France

  • Hôpital Huriez

    Lille, 59037, France

  • Hôpital Michallon

    Grenoble, 38043, France

  • Hôpital Mondor

    Créteil, 94010, France

  • Hôpital Purpan

    Toulouse, 31059, France

  • Hôpital St Louis

    Paris, 75010, France

  • Hôpital Sud - CHU Amiens

    Amiens, 80054, France

  • Hôpital V. Provo

    Roubaix, 59056, France

  • Hôpital Victor Dupouy

    Argenteuil, 95107, France

  • Hôpital de Corbeil

    Corbeil, 91100, France

  • Institut Gustave Roussy

    Villejuif, 94800, France

  • Institut Paoli-Calmette

    Marseille, 13273, France

  • Paris Necker

    Paris, 75743, France

  • Pitié-Salpetrière

    Paris, 75013, France

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