NCT00932412: CLARA

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).

Completed Phase 2 Last updated 22 May 2026

What this trial tests

Phase 2 trial testing CLARA in Acute Myeloid Leukemia in 735 participants. Completed in 1 April 2016.

Timeline

1 March 2009

Primary endpoint
1 April 2016

1 April 2016

Quick facts

Lead sponsor	Hospices Civils de Lyon
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	735
Start date	1 March 2009
Primary completion	1 April 2016
Estimated completion	1 April 2016
Sites	34 locations across France

Drugs / interventions tested

• CLARA — full drug profile →
• HDAc — full drug profile →

Conditions studied

• Acute Myeloid Leukemia — all drugs for Acute Myeloid Leukemia →

Sponsor

Hospices Civils de Lyon — full company profile →

Who can join

Adults 18 to 60, any sex, with Acute Myeloid Leukemia. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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
  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 t

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Prognostic impact of DDX41 germline mutations in intensively treated acute myeloid leukemia patients: an ALFA-FILO study.
   Duployez N, Largeaud L, Duchmann M, Kim R, et al · · 2022 · cited 69× · PMID 35443031 · DOI 10.1182/blood.2021015328
2. A personalized approach to guide allogeneic stem cell transplantation in younger adults with acute myeloid leukemia.
   Fenwarth L, Thomas X, de Botton S, Duployez N, et al · · 2021 · cited 39× · PMID 32871585 · DOI 10.1182/blood.2020005524
3. Clinical relevance of <i>IDH1/2</i> mutant allele burden during follow-up in acute myeloid leukemia. A study by the French ALFA group.
   Ferret Y, Boissel N, Helevaut N, Madic J, et al · · 2018 · cited 34× · PMID 29472349 · DOI 10.3324/haematol.2017.183525
4. UBTF tandem duplications define a distinct subtype of adult de novo acute myeloid leukemia.
   Duployez N, Vasseur L, Kim R, Largeaud L, et al · · 2023 · cited 22× · PMID 37085611 · DOI 10.1038/s41375-023-01906-z
5. Early detection of WT1 measurable residual disease identifies high-risk patients, independent of transplantation in AML.
   Lambert J, Lambert J, Thomas X, Marceau-Renaut A, et al · · 2021 · cited 22× · PMID 34625784 · DOI 10.1182/bloodadvances.2021004322
6. Multi-target measurable residual disease assessed by error-corrected sequencing in patients with acute myeloid leukemia: An ALFA study.
   Hirsch P, Lambert J, Bucci M, Deswarte C, et al · · 2024 · cited 9× · PMID 38871702 · DOI 10.1038/s41408-024-01078-8
7. LSC17 score complements genetics and measurable residual disease in acute myeloid leukemia: an ALFA study.
   Vasseur L, Fenwarth L, Lambert J, de Botton S, et al · · 2023 · cited 5× · PMID 37205853 · DOI 10.1182/bloodadvances.2023010155
8. Clofarabine Improves Relapse-Free Survival of Acute Myeloid Leukemia in Younger Adults with Micro-Complex Karyotype.
   Fenwarth L, Duployez N, Thomas X, Boissel N, et al · · 2019 · cited 5× · PMID 31905904 · DOI 10.3390/cancers12010088