Clinical trial NCT05070208: Multicenter Retrospective Observatory of Patients With Acute Myeloid Leukemia to Core Binding Factor
Official title: Multicenter Retrospective Observatory of Patients With Acute Myeloid Leukemia to Core Binding Factor
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myeloblastic Leukemia Core Binding Factor
Lead sponsor: Acute Leukemia French Association
Sponsor class: OTHER
First posted: 2021-10-07
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Core Binding Factor Acute Myeloid Leukemia

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

Eligibility criteria: 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

Primary outcomes:
measure: Event-free survival (EFS)
timeFrame: December 2010 to December 2020
Secondary outcomes:
measure: - Complete remission rate (CR / CRp)
timeFrame: December 2010 to December 2020
measure: - Overall survival (OS), relapse free survival (DFS) +/- censored with allogeneic transplant
timeFrame: December 2010 to December 2020
measure: - Cumulative incidence of relapse (CIR) +/- censored at allograft
timeFrame: December 2010 to December 2020
measure: - Second complete remission rate, OS, EFS, DFS and CIR post-relapse
timeFrame: December 2010 to December 2020
measure: -Prognostic impact on OS, CR, EFS, DFS and CIR of recurrent somatic mutations
timeFrame: December 2010 to December 2020
measure: - Interaction between mutations and MRD on OS, CR, EFS, DFS and CIR
timeFrame: December 2010 to December 2020
measure: - Cumulative incidence of molecular relapse.
timeFrame: December 2010 to December 2020
measure: - Prognostic impact on OS, CR, EFS, DFS, CIR and post-relapse survival of using first-line GO and relapsing
timeFrame: December 2010 to December 2020
Other outcomes:
Locations:
city: Amiens
country: France
facility: Chu Amiens
city: Argenteuil
country: France
facility: Centre Hospitalier Victor Dupouy
city: Bobigny
country: France
facility: AP-HP-GHU - Hôpital AVICENNE
city: Caen
country: France
facility: CHU de la cote de Nacre
city: Chambéry
country: France
facility: CH Métropole Savoie
city: Clamart
country: France
facility: Hôpital MILITAIRE PERCY
city: Corbeil-Essonnes
country: France
facility: Centre hospitalier Sud Francilien
city: Créteil
country: France
facility: Henri Mondor Aphp
city: Dijon
country: France
facility: Dijon Chu
city: Dunkerque
country: France
facility: Centre Hospitalier de Dunkerque
city: Le Chesnay
country: France
facility: Centre Hospitalier de Versailles André Mignot
city: Lens
country: France
facility: LENS CHR
city: Lille
country: France
facility: CHU
city: Limoges
country: France
facility: Limoges Chu
city: Marseille
country: France
facility: CHU La Conception
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Nice
country: France
facility: CHU Nice,Hopital Archet 1
city: Paris
country: France
facility: Hopital Pitié-Salpétrière APHP
city: Paris
country: France
facility: Hôpital Necker - APHP
city: Paris
country: France
facility: Hôpital Saint Louis- APHP
city: Paris
country: France
facility: Saint Antoine
city: Pierre-Bénite
country: France
facility: Centre Hospitalier Lyon Sud
city: Pontoise
country: France
facility: Centre Hospitalier René Dubos
city: Roubaix
country: France
facility: Centre Hospitalier de Roubaix
city: Saint-Quentin
country: France
facility: Centre Hospitalier de St Quentin
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: SAINT LOUIS PARIS
name: ITZYKSON Raphael, Dr
role: PRINCIPAL_INVESTIGATOR
References: