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Acute Myeloid LeukemiaPhase 2CLARANCT00932412

The CLARA Study From the Acute Leukemia French Association (ALFA 0702 Trial)

A Phase 2 study testing CLARA and HDAc in people with Acute Myeloid Leukemia, run by Hospices Civils de Lyon at 34 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is a phase II randomized multicenter study. Patients will be enrolled at time of diagnosis and will receive one or two cycles of induction chemotherapy. Patients, without indication of intensification by allogeneic stem cell transplantation and/or without HLA (Human Leukocyte Antigen)-compatible donor, who… Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Acute Myeloid Leukemia
What is being tested?
CLARA and HDAc
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
735 participants
Where
34 sitesFrance
Study dates
Mar 2009to Apr 2016
Phase
Phase 2
Are there results?
None posted in the registry

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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Age 18 years or more and less than 60 years
  • With:
  • A morphologically proven diagnosis of AML according to the WHO classification, cytogenetically (standard karyotype, FISH-MLL) and molecularly (FLT3, CEBPA, NMP1) defined.
  • ECOG (Eastern Cooperative Oncology Group) performance status 0 to 2.
  • Have adequate renal and hepatic function as indicated by the following laboratory values:
  • Creatinine clearance (calculated by the cockcroft and Gault method) ≥ 40mL/min;
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  • AST (Aspartate amino transférase) and ALT (Alanine Amino Transférase ) < or = 2.5N; total bilirubin < or = 2N (unless related to the underlying disease).
  • Cardiac function determined by radionuclide or echography within normal limits.
  • 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.
  • Must be able and willing to give written informed consent.
  • The subject must be covered by a social security system.
  • Patients with either in first CR/CRp after the first induction course or in first CR/CRp after salvage therapy.
  • ECOG performance status 0 to 2.
  • AST and ALT < or = 2.5N; total bilirubin < or = 2N.
  • Creatinine clearance ≥40mL/min (calculated by the cockcroft and Gault method or by MDRD (see http://nephron.org/cgi-bin/MDRD_GFR/cgi)
  • Patient without HLA identical donor.

Who cannot join

  • Patients with AML with favorable risk cytogenetics: M3-AML; CBF-AML including t(8:21), inv(16), or t(16;16) AML.
  • Ph-positive AML.
  • AML following diagnosed myeloproliferation or patient with prior history of MDS known for more than 3 months
  • Prior treatment with chemotherapy or radiotherapy for another tumor.
  • Prior tumor, if not stable for at least two years, except in-situ carcinoma and skin carcinoma
  • Compromised organ function judged to be lifethreatening by the Investigator.
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  • Positive serology for HIV (Human Immunodeficiency Virus), HBV (Hepatitis B Virus) and HBC (Hepatitis C Virus)(except post vaccination)
  • 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.
  • Other active malignancy.
  • Patients concurrently receiving any other standard or investigational treatment for their leukemia, with the exception of hydroxyurea.
  • 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).
  • Known central nervous system involvement with AML.
  • Uncontrolled active infection of any kind or bleeding.
  • Compromized organ function judged to be lifethreatening by the Investigator.
  • Patient with HLA identical donor identified.

Trial locations and contacts

34 sites in 1 country.

34 sites in 1 country

France34 sites

  • Hôpital Sud - CHU Amiens

    Amiens, 80054

  • Centre Hospitalier Regional et Universitaire d'Angers

    Angers, 49033

  • Hôpital Victor Dupouy

    Argenteuil, 95107

  • Hôpital Avicenne - bobigny

    Bobigny, 93009

  • Centre Hospitalier Boulogne/Mer

    Boulogne-sur-Mer, 62280

  • Hôpital Clemenceau - chu Caen

    Caen, 14033

  • Centre Hospitalier René Dubos

    Cergy-Pontoise, 95303

  • HIA Percy

    Clamart, 92141

  • Hôpital de Corbeil

    Corbeil, 91100

  • Hôpital Mondor

    Créteil, 94010

  • Hôpital Dubocage

    Dijon, 21000

  • Centre Hospitalier Dunkerque

    Dunkirk, 59395

  • Hôpital Michallon

    Grenoble, 38043

  • Centre Hospitalier Versailles

    Le Chesnay, 78150

  • Centre Hospitalier Schaffner

    Lens, 62307

  • Hôpital Huriez

    Lille, 59037

  • CHU Dupuytren

    Limoges, 87042

  • Institut Paoli-Calmette

    Marseille, 13273

  • Centre Hospitalier Meaux

    Meaux, 77104

  • CHU - Hôtel Dieu

    Nantes, 44093

  • Centre A. Lacassagne

    Nice, 06100

  • Hôpital Archet 1

    Nice, 06202

  • Hôpital St Louis

    Paris, 75010

  • Pitié-Salpetrière

    Paris, 75013

  • Paris Necker

    Paris, 75743

  • Hôpital Haut Lévêque

    Pessac, 33604

  • Hospices Civils de Lyon - Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • Hôpital V. Provo

    Roubaix, 59056

  • Centre Henri Becquerel - CHRU ROUEN

    Rouen, 76038

  • Centre Hospitalier Huguenin

    Saint-Cloud, 92210

  • Hôpital Purpan

    Toulouse, 31059

  • Centre Hospitalier Valenciennes

    Valenciennes, 59322

  • CHU de Brabois

    Vandœuvre-lès-Nancy, 54511

  • Institut Gustave Roussy

    Villejuif, 94800

Other trials in France

About this study

Official title: A Randomized Phase II Study of Clofarabine / Intermediate-Dose Cytarabine (CLARA)Versus High-Dose Cytarabine (HDAC) as Consolidation in Younger Patients With Newly-Diagnosed Acute Myeloid Leukemia (AML).

This study is a phase II randomized multicenter study. Patients will be enrolled at time of diagnosis and will receive one or two cycles of induction chemotherapy. Patients, without indication of intensification by allogeneic stem cell transplantation and/or without HLA (Human Leukocyte Antigen)-compatible donor, who attain a CR after one or two cycles of induction chemotherapy, will be eligible for the study Clofarabine / Intermediate-Dose Cytarabine (CLARA)versus High-Dose Cytarabine (HDAC)and will be randomized between 3 courses of CLARA chemotherapy and 3 courses of HDAC chemotherapy as consolidation.

We will compare efficacy and toxicity among the two arms.

Read the detailed description

Because of the results of our former trial (ALFA-9802) [Thomas, 2005], chemotherapy will be combined in each arm with G-CSF (Granulocyte Colony-Stimulating Factor) given during each sequence of chemotherapy in order to increase the blast priming.

Being tested
CLARA, HDAc
Keywords
Younger Patients with Newly-Diagnosed Acute Myeloid Leukemia (AML).
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.

  • CLARADrug

    Clofarabine 30 mg/m2/day IV (2h) on days 2 to 6 (administered as a 2h infusion in 250 ml of 0.9% normal saline solution) Cytarabine 1 g/m2/day intravenous (2h) 4 hours later on days 1 to 5 (administered as a 2h infusion in 250 ml of 5% dextrose in water) G-CSF 5 microg/kg/day intravenous from day 1 to day 6 (administered as a 30 mn infusion in 20 ml of dextrose 5% in water)

  • HDAcDrug

    Cytarabine 3 g/m2/12h intravenous (3h) on days 1, 3, 5 (administered as a 3h infusion in 250 ml of 5% dextrose in water) G-CSF 5 microg/kg/day intravenous from day 1 to day 5 (administered as a 30 mn infusion in 20 ml of dextrose 5% in water)

Study groups in NCT00932412
Study groupRoleWhat they receive
CLARAExperimentalClofarabine / Intermediate-Dose Cytarabine (CLARA) with G-CSF given during each sequence of chemotherapy in order to increase the blast priming.
Receives: Drug: CLARA
HDACActive comparatorHigh-Dose Cytarabine (HDAC) with G-CSF given during each sequence of chemotherapy in order to increase the blast priming.
Receives: Drug: HDAc

What is being measured

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

  1. DFS (disease free survival) following first remission achievement (CR : Complete Remission or CRp : Complete Remission but platelet count < 100 x109/L) in younger patients with intermediate-risk or unfavorable-risk AML.

    As all these patients are eligible for allogenic stem cell transplantation in first remission if they have a donor and the comparison of interest primarily concerns non-transplanted patients, it is planned: 1) to exclude patients with an identified donor; 2) to adjust Relapse Free survival (RFS) comparison on the interaction with stem cell transplantation in first remission; and 3) to censure at transplant time the patients allografted before disease progression after randomization (late donor identification) as sensitivity analysis.

    Measured: 2 years

Secondary outcomes (5)

  1. • Safety profile of CLARA versus HDAC consolidation courses

    All toxicity encountered during therapy will be evaluated according to the CTC expanded Common Toxicity Criteria and causal relationship to investigational products will be reported.

    Serious Adverse Events encountered 3 MONTHS after the last cycle of study chemotherapy (induction/salvage/CLARA/HDAC), whether or not ascribed to the study, will be recorded in the Serious Adverse Event form.

    Measured: 2 years

  2. • Possible predictors to response

    Possible predictors to response: with respect to cytogenetics risk groups and mutational status: FLT3 (Fms-like tyrosine kinase 3), MLL (myeloid/ lymphoid or mixed-lineage leukemia), CEBPA (CCAAT / enhancer binding protein α) and NPM(Nucleophosmin))

    Measured: 2 years

  3. • MRD (Minimal Residual Disease) level

    Evaluation of MRD in patients with AML in clinical remission is a potentially useful tool for assessing the risk of relapse and guiding further therapeutic decisions. Once an aberrant pattern is identified at diagnosis, it will serve as a "patient-specific probe" to be used, with standard triple/quadruple labelling, to track residual disease longitudinally. Bone marrow and peripheral blood samples for MRD evaluation will be collected at fixed time points:

    • End of induction in patients achieving CR/CRp.
    • End of consolidation 3.
    • Every 6 months during follow-up for 2 years.

    Measured: 2 years

  4. • Overall cumulative incidence of relapse

    Measured: 120 days

  5. • Overall survival (OS)

    OS will be defined as the time from diagnosis to death or last contact with the patient

    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 posted3 Jul 2009 (estimated)
  2. Study startMar 2009
  3. Primary completionApr 2016
  4. Study completionApr 2016

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
735 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00932412
Sponsor's protocol ID
2006.456/50
Other IDs
2008-000668-18, 2008
Acronym
CLARA
Status last verified
May 2026
First submitted
2 Jul 2009
Last updated
27 May 2026
Results posted
No
Data monitoring committee
Yes

Publications

  • Fenwarth L, Thomas X, de Botton S, Duployez N, Bourhis JH, Lesieur A, Fortin G, Meslin PA, Yakoub-Agha I, Sujobert P, Dumas PY, Recher C, Lebon D, Berthon C, Michallet M, Pigneux A, Nguyen S, Chantepie S, Vey N, Raffoux E, Celli-Lebras K, Gardin C, Lambert J, Malfuson JV, Caillot D, Maury S, Ducourneau B, Turlure P, Lemasle E, Pautas C, Chevret S, Terre C, Boissel N, Socie G, Dombret H, Preudhomme C, Itzykson R. A personalized approach to guide allogeneic stem cell transplantation in younger adults with acute myeloid leukemia. Blood. 2021 Jan 28;137(4):524-532. doi: 10.1182/blood.2020005524.

    PubMed 32871585

  • Hirsch P, Lambert J, Bucci M, Deswarte C, Boudry A, Lambert J, Fenwarth L, Micol JB, Terre C, Celli-Lebras K, Thomas X, Dombret H, Duployez N, Preudhomme C, Itzykson R, Delhommeau F. Multi-target measurable residual disease assessed by error-corrected sequencing in patients with acute myeloid leukemia: An ALFA study. Blood Cancer J. 2024 Jun 13;14(1):97. doi: 10.1038/s41408-024-01078-8.

    PubMed 38871702

  • Michallet M, Sobh M, Morisset S, Deloire A, Raffoux E, de Botton S, Caillot D, Chantepie S, Girault S, Berthon C, Bertoli S, Lepretre S, Leguay T, Castaigne S, Marolleau JP, Pautas C, Malfuson JV, Veyn N, Braun T, Gastaud L, Suarez F, Schmidt A, Gressin R, Bonmati C, Celli-Lebras K, El-Hamri M, Ribaud P, Dombret H, Thomas X, Bergeron A. Antifungal Prophylaxis in AML Patients Receiving Intensive Induction Chemotherapy: A Prospective Observational Study From the Acute Leukaemia French Association (ALFA) Group. Clin Lymphoma Myeloma Leuk. 2022 May;22(5):311-318. doi: 10.1016/j.clml.2021.10.011. Epub 2021 Oct 25.

    PubMed 34895843

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CLARA and HDAc in people with Acute Myeloid Leukemia, run by Hospices Civils de Lyon at 34 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: finished, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DFS (disease free survival) following first remission achievement (CR : Complete Remission or CRp : Complete Remission but platelet count < 100 x109/L) in younger patients with intermediate-risk or unfavorable-risk AML. (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 NCT00932412, which also lists 3 linked publications.

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 27 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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