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NCT05070208: RETRO-CBF

Multicenter Retrospective Observatory of Patients With Acute Myeloid Leukemia to Core Binding Factor

Completed Last updated 2 October 2025
What this trial tests

trial testing NOT PROVIDED in Acute Myeloblastic Leukemia Core Binding Factor in 400 participants. Completed in 5 May 2024.

Timeline
22 September 2021
Primary endpoint
25 January 2024
5 May 2024

Quick facts

Lead sponsorAcute Leukemia French Association
StatusCompleted
Study typeOBSERVATIONAL
Enrollment400
Start date22 September 2021
Primary completion25 January 2024
Estimated completion5 May 2024
Sites26 locations across France

Drugs / interventions tested

Conditions studied

Sponsor

Acute Leukemia French Association

Who can join

18 and older, any sex, with Acute Myeloblastic Leukemia Core Binding Factor. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Acute Core Binding Factor leukemias represent a specific category of acute myeloid leukemias that share prognostic factors, a specific mutational profile, and a favorable response to chemotherapy. Their management now follows the reference pattern from the French trial CBF-2006 closed to inclusions since November 2010. This includes intensive chemotherapy and intensification by allogeneic marrow transplant depending on the residual disease measured by RT qPCR . These leukemias have not been the subject of multicenter clinical trials since that date. The results of this treatment regimen need to be evaluated. Known prognostic factors such as signaling mutations, clonal interference or residual disease follow-up (MRD) will be analyzed and updated in this recent cohort. The interaction between residual disease and mutational profile will be evaluated on the prognosis. Treatment with gemtuzumab-ozogamycin and first-line allogeneic transplantation will be investigated, depending on prognostic factors including associated mutations and residual disease. The course and early treatment of molecular relapses will be analyzed. The treatment and prognosis of cytological relapses will be described with in particular the role of tyrosine kinase inhibitors and therapeutic intensification.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Genetic alterations and measurable residual disease in core binding factor acute myeloid leukemia.
    Vasseur L, Duchmann M, Duployez N, Raffoux E, et al · · 2026 · PMID 41888395 · DOI 10.1038/s41375-026-02900-x

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