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

Study Overview
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Brief Summary
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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
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NOT PROVIDED

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

Conditions
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Acute Myeloblastic Leukemia Core Binding Factor

Intervention / Treatment
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* Other: NOT PROVIDED


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: NOT PROVIDED|NOT PROVIDED|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event-free survival (EFS) |  | December 2010 to December 2020 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - 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 | 
| - Interaction between mutations and MRD on OS, CR, EFS, DFS and CIR |  | December 2010 to December 2020 | 
| - Cumulative incidence of molecular relapse. |  | 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 |