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

Completed

• Conditions: Acute Myeloblastic Leukemia Core Binding Factor

• Registration Number: NCT05070208
• Lead Sponsor: Acute Leukemia French Association

Brief 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

Study Timeline

• Study Start: 2021-09-22
• Study First Submitted: 2021-09-27
• Study First Submitted QC: 2021-09-27
• Study First Posted: 2021-10-07
• Status Verified: 2024-01
• Primary Completion: 2024-01-25
• Study Completion: 2024-01-25
• Last Update Submitted: 2024-01-30
• Last Update Posted: 2024-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Patients over 18 years old
• Diagnosis of acute myeloid leukemia with CBF confirmed by cytogenetics (karyotype and / or FISH): t (8; 21), inv (16) or t (16; 16) and / or molecular biology (RUNX1-RUNX1T1 fusions or CBFB-MYH11)
• Initial management by intensive chemotherapy, hypomethylants or targeted therapies

Exclusion Criteria

• Opposition expressed to research

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Event-free survival (EFS)	December 2010 to December 2020

Secondary Outcome Measures

Name	Time	Method
- Complete remission rate (CR / CRp)	December 2010 to December 2020
-Prognostic impact on OS, CR, EFS, DFS and CIR of recurrent somatic mutations	December 2010 to December 2020
- Cumulative incidence of molecular relapse.	December 2010 to December 2020
- Cumulative incidence of relapse (CIR) +/- censored at allograft	December 2010 to December 2020
- Overall survival (OS), relapse free survival (DFS) +/- censored with allogeneic transplant	December 2010 to December 2020
- Second complete remission rate, OS, EFS, DFS and CIR post-relapse	December 2010 to December 2020
- Interaction between mutations and MRD on OS, CR, EFS, DFS and CIR	December 2010 to December 2020
- Prognostic impact on OS, CR, EFS, DFS, CIR and post-relapse survival of using first-line GO and relapsing	December 2010 to December 2020

Trial Locations

Locations (26)

Centre Hospitalier de Dunkerque; 🇫🇷 Dunkerque, France

Chu Amiens; 🇫🇷 Amiens, France

Centre Hospitalier Victor Dupouy; 🇫🇷 Argenteuil, France

AP-HP-GHU - Hôpital AVICENNE; 🇫🇷 Bobigny, France

Centre Hospitalier de Versailles André Mignot; 🇫🇷 Le Chesnay, France

Hôpital Saint Louis- APHP; 🇫🇷 Paris, France

Centre Antoine Lacassagne; 🇫🇷 Nice, France

CHU La Conception; 🇫🇷 Marseille, France

Centre Hospitalier René Dubos; 🇫🇷 Pontoise, France

Institut Gustave Roussy; 🇫🇷 Villejuif, France

CHU Nice,Hopital Archet 1; 🇫🇷 Nice, France

Hopital Pitié-Salpétrière APHP; 🇫🇷 Paris, France

Hôpital Necker - APHP; 🇫🇷 Paris, France

Centre Hospitalier Lyon Sud; 🇫🇷 Pierre-Bénite, France

CHU de la cote de Nacre; 🇫🇷 Caen, France

CH Métropole Savoie; 🇫🇷 Chambéry, France

Hôpital MILITAIRE PERCY; 🇫🇷 Clamart, France

Henri Mondor Aphp; 🇫🇷 Créteil, France

Dijon Chu; 🇫🇷 Dijon, France

Centre hospitalier Sud Francilien; 🇫🇷 Corbeil-Essonnes, France

LENS CHR; 🇫🇷 Lens, France

CHU; 🇫🇷 Lille, France

Limoges Chu; 🇫🇷 Limoges, France

Centre Hospitalier de Roubaix; 🇫🇷 Roubaix, France

Saint Antoine; 🇫🇷 Paris, France

Centre Hospitalier de St Quentin; 🇫🇷 Saint-Quentin, France