Multicenter Retrospective Observatory of Patients With Acute Myeloid Leukemia to Core Binding Factor (RETRO-CBF)

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.

Study Overview

• Status: Completed
• Conditions: Acute Myeloblastic Leukemia Core Binding Factor
• Intervention / Treatment: Other: NOT PROVIDED

Detailed Description

NOT PROVIDED

• Study Type: Observational
• Enrollment (Actual): 400

Contacts and Locations

• Study Contact: Name: Raphael ITZYKSON, Dr; Phone Number: +33 1 71 20 70 31; Email: raphael.itzykson@aphp.fr
• Study Contact Backup: Name: Nicolas BOISSEL, Pr; Phone Number: +33 1 42 49 96 09; Email: nicolas.boissel@aphp.fr

Study Locations

• France
  • Amiens, France
    • CHU Amiens
  • Argenteuil, France
    • Centre Hospitalier Victor Dupouy
  • Bobigny, France
    • AP-HP-GHU - Hôpital AVICENNE
  • Caen, France
    • CHU de la cote de Nacre
  • Chambéry, France
    • CH Metropole Savoie
  • Clamart, France
    • Hôpital MILITAIRE PERCY
  • Corbeil-Essonnes, France
    • Centre Hospitalier Sud Francilien
  • Créteil, France
    • Henri Mondor Aphp
  • Dijon, France
    • Dijon CHU
  • Dunkerque, France
    • Centre Hospitalier de Dunkerque
  • Le Chesnay, France
    • Centre Hospitalier de Versailles André Mignot
  • Lens, France
    • LENS CHR
  • Lille, France, 59037
    • CHU
  • Limoges, France
    • Limoges CHU
  • Marseille, France
    • CHU la Conception
  • Nice, France
    • Centre Antoine Lacassagne
  • Nice, France
    • CHU Nice,Hopital Archet 1
  • Paris, France
    • Hopital Pitie-Salpetriere APHP
  • Paris, France
    • Hôpital Necker - APHP
  • Paris, France
    • Hôpital Saint Louis- APHP
  • Paris, France
    • Saint Antoine
  • Pierre-Bénite, France
    • Centre Hospitalier Lyon Sud
  • Pontoise, France
    • Centre Hospitalier Rene Dubos
  • Roubaix, France
    • Centre Hospitalier de Roubaix
  • Saint-Quentin, France
    • Centre Hospitalier de St Quentin
  • Villejuif, France
    • Institut Gustave Roussy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Core Binding Factor Acute Myeloid Leukemia

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Acute Leukemia French Association
• Investigators: Principal Investigator: ITZYKSON Raphael, Dr, SAINT LOUIS PARIS

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2021
• Primary Completion (Actual): January 25, 2024
• Study Completion (Actual): January 25, 2024

Study Registration Dates

• First Submitted: September 27, 2021
• First Submitted That Met QC Criteria: September 27, 2021
• First Posted (Actual): October 7, 2021

Study Record Updates

• Last Update Posted (Estimated): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Leukemia, Myeloid; Leukemia; Leukemia, Myeloid, Acute
• Other Study ID Numbers: RETRO-CBF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No