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

NCT05070208 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2025-10-02

No results posted yet for this study

Summary

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.

Conditions

  • Acute Myeloblastic Leukemia Core Binding Factor

Interventions

OTHER

NOT PROVIDED

NOT PROVIDED

Sponsors & Collaborators

  • Acute Leukemia French Association

    lead OTHER

Principal Investigators

  • ITZYKSON Raphael, Dr · SAINT LOUIS PARIS

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-22
Primary Completion
2024-01-25
Completion
2024-05-05

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05070208 on ClinicalTrials.gov