NCT04931992UnknownNot Applicable
Outcome of Patients With CBF and/or NPM1-mutated AML in First Molecular Relapse.
University Hospital, Angers1 site in 1 country100 target enrollmentStarted: June 1, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Event-free survival
Study Overview
Brief 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to 61 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Event-free survival
Time Frame: Up to 5 years
Secondary Outcomes
- Overall survival(Up to 5 years)
Investigators
Study Sites (1)
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