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OpenTrials
Completed

NCT Number: NCT05070208

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Amiens, Amiens, France

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About this study

NOT PROVIDED

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Not provided

Other

NOT PROVIDED

Primary outcomes

  1. Event-free survival (EFS)

    Time frame: December 2010 to December 2020

Secondary outcomes

  1. - Complete remission rate (CR / CRp)

    Time frame: December 2010 to December 2020

  2. - Overall survival (OS), relapse free survival (DFS) +/- censored with allogeneic transplant

    Time frame: December 2010 to December 2020

  3. - Cumulative incidence of relapse (CIR) +/- censored at allograft

    Time frame: December 2010 to December 2020

  4. - Second complete remission rate, OS, EFS, DFS and CIR post-relapse

    Time frame: December 2010 to December 2020

  5. -Prognostic impact on OS, CR, EFS, DFS and CIR of recurrent somatic mutations

    Time frame: December 2010 to December 2020

  6. - Interaction between mutations and MRD on OS, CR, EFS, DFS and CIR

    Time frame: December 2010 to December 2020

  7. - Cumulative incidence of molecular relapse.

    Time frame: December 2010 to December 2020

  8. - Prognostic impact on OS, CR, EFS, DFS, CIR and post-relapse survival of using first-line GO and relapsing

    Time frame: December 2010 to December 2020

Sponsors and collaborators

Lead sponsor

Acute Leukemia French Association

Other

Registry information

Acronym: RETRO-CBF

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Oct 7, 2021
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.