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

NCT ID: NCT05070208

Last Updated: 2025-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-22

Study Completion Date

2024-05-05

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

Conditions

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Acute Myeloblastic Leukemia Core Binding Factor

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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NOT PROVIDED

NOT PROVIDED

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Acute Leukemia French Association

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ITZYKSON Raphael, Dr

Role: PRINCIPAL_INVESTIGATOR

SAINT LOUIS PARIS

Locations

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Chu Amiens

Amiens, , France

Site Status

Centre Hospitalier Victor Dupouy

Argenteuil, , France

Site Status

AP-HP-GHU - Hôpital AVICENNE

Bobigny, , France

Site Status

CHU de la cote de Nacre

Caen, , France

Site Status

CH Métropole Savoie

Chambéry, , France

Site Status

Hôpital MILITAIRE PERCY

Clamart, , France

Site Status

Centre hospitalier Sud Francilien

Corbeil-Essonnes, , France

Site Status

Henri Mondor Aphp

Créteil, , France

Site Status

Dijon Chu

Dijon, , France

Site Status

Centre Hospitalier de Dunkerque

Dunkirk, , France

Site Status

Centre Hospitalier de Versailles André Mignot

Le Chesnay, , France

Site Status

LENS CHR

Lens, , France

Site Status

CHU

Lille, , France

Site Status

Limoges Chu

Limoges, , France

Site Status

CHU La Conception

Marseille, , France

Site Status

Centre Antoine Lacassagne

Nice, , France

Site Status

CHU Nice,Hopital Archet 1

Nice, , France

Site Status

Hopital Pitié-Salpétrière APHP

Paris, , France

Site Status

Hôpital Necker - APHP

Paris, , France

Site Status

Hôpital Saint Louis- APHP

Paris, , France

Site Status

Saint Antoine

Paris, , France

Site Status

Centre Hospitalier Lyon Sud

Pierre-Bénite, , France

Site Status

Centre Hospitalier René Dubos

Pontoise, , France

Site Status

Centre Hospitalier de Roubaix

Roubaix, , France

Site Status

Centre Hospitalier de St Quentin

Saint-Quentin, , France

Site Status

Institut Gustave Roussy

Villejuif, , France

Site Status

Countries

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France

Other Identifiers

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RETRO-CBF

Identifier Type: -

Identifier Source: org_study_id

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