Multicenter Retrospective Observatory of Patients With Acute Myeloid Leukemia to Core Binding Factor
RETRO-CBF
1 other identifier
observational
400
1 country
26
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2021
Typical duration for all trials
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 22, 2021
CompletedFirst Submitted
Initial submission to the registry
September 27, 2021
CompletedFirst Posted
Study publicly available on registry
October 7, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 25, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 5, 2024
CompletedOctober 2, 2025
September 1, 2025
2.3 years
September 27, 2021
September 29, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Event-free survival (EFS)
December 2010 to December 2020
Secondary Outcomes (8)
- Complete remission rate (CR / CRp)
December 2010 to December 2020
- Overall survival (OS), relapse free survival (DFS) +/- censored with allogeneic transplant
December 2010 to December 2020
- Cumulative incidence of relapse (CIR) +/- censored at allograft
December 2010 to December 2020
- Second complete remission rate, OS, EFS, DFS and CIR post-relapse
December 2010 to December 2020
-Prognostic impact on OS, CR, EFS, DFS and CIR of recurrent somatic mutations
December 2010 to December 2020
- +3 more secondary outcomes
Interventions
NOT PROVIDED
Eligibility Criteria
Core Binding Factor Acute Myeloid Leukemia
You may qualify if:
- 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
You may not qualify if:
- \- Opposition expressed to research
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
Chu Amiens
Amiens, France
Centre Hospitalier Victor Dupouy
Argenteuil, France
AP-HP-GHU - Hôpital AVICENNE
Bobigny, France
CHU de la cote de Nacre
Caen, France
CH Métropole Savoie
Chambéry, France
Hôpital MILITAIRE PERCY
Clamart, France
Centre hospitalier Sud Francilien
Corbeil-Essonnes, France
Henri Mondor Aphp
Créteil, France
Dijon Chu
Dijon, France
Centre Hospitalier de Dunkerque
Dunkirk, France
Centre Hospitalier de Versailles André Mignot
Le Chesnay, France
LENS CHR
Lens, France
CHU
Lille, 59037, France
Limoges Chu
Limoges, France
CHU La Conception
Marseille, France
Centre Antoine Lacassagne
Nice, France
CHU Nice,Hopital Archet 1
Nice, France
Hopital Pitié-Salpétrière APHP
Paris, France
Hôpital Necker - APHP
Paris, France
Hôpital Saint Louis- APHP
Paris, France
Saint Antoine
Paris, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, France
Centre Hospitalier René Dubos
Pontoise, France
Centre Hospitalier de Roubaix
Roubaix, France
Centre Hospitalier de St Quentin
Saint-Quentin, France
Institut Gustave Roussy
Villejuif, France
Study Officials
- PRINCIPAL INVESTIGATOR
ITZYKSON Raphael, Dr
SAINT LOUIS PARIS
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 27, 2021
First Posted
October 7, 2021
Study Start
September 22, 2021
Primary Completion
January 25, 2024
Study Completion
May 5, 2024
Last Updated
October 2, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share