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NCT04931992 Clinical Trial

Outcome of Patients With CBF and/or NPM1-mutated AML in First Molecular Relapse.

Acute Myeloid Leukemia Clinical Trial

— MOLAM  

Official title:
Outcome of Patients With CBF and/or NPM1-mutated AML in First Molecular Relapse.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04931992
Other study ID # 202100042
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 1, 2021
Est. completion date December 31, 2021

Study information
Verified date June 2021
Source University Hospital, Angers
Contact Corentin Orvain, MD, PhD
Phone +33241354475
Email corentin.orvain@chu-angers.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Despite good initial response, some patients with core binding factor and/or NPM1-mutated AML eventually relapse. Some of these patients can be identified earlier on, before overt cytological relapse, when followed for minimal residual disease. The outcome of patients treated when molecular relapse is confirmed, before overt cytological relapse, is not well known. This multi-center retrospective will therefore study the outcome of these patients and try to specify the role of allogeneic stem cell transplantation in this setting.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers
Gender All
Age group 18 Years to 61 Years
Eligibility Inclusion Criteria: - Patients between 18 and 61 years - Diagnosis between 2010 and 2019 - Core binding factor and/or NPM1 acute myeloid leukemia - First complete remission after induction therapy - Measurable residual disease measurement after end of consolidation therapy Exclusion Criteria: - Acute promyelocytic leukemia - Allogeneic stem cell transplantation in CR1

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• No intervention
Retrospective analysis

Locations
Country Name City State
France Angers University Hospital Angers

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Event-free survival Up to 5 years
Secondary Overall survival Up to 5 years
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