NCT05070208

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 400 (actual)
• Sponsor: Acute Leukemia French Association · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Detailed description

NOT PROVIDED

Conditions

• Acute Myeloblastic Leukemia Core Binding Factor

Interventions

Type	Name	Description
OTHER	NOT PROVIDED	NOT PROVIDED

Timeline

• Start date: 2021-09-22
• Primary completion: 2024-01-25
• Completion: 2024-05-05
• First posted: 2021-10-07
• Last updated: 2025-10-02

Locations

26 sites across 1 country: France