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

Sponsor
University Hospital, Angers (Other)
Overall Status
Recruiting
CT.gov ID
NCT04931992
Collaborator
(none)
100
1
7
14.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: No intervention

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Outcome of Patients With CBF and/or NPM1-mutated AML in First Molecular Relapse.
Actual Study Start Date :
Jun 1, 2021
Anticipated Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Dec 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Molecular relapse

Confirmed molecular relapse, without overt cytological relapse

Other: No intervention
Retrospective analysis

Cytological relapse

Overt cytological relapse, without prior molecular relapse

Other: No intervention
Retrospective analysis

Persistent responders

No molecular or cytological relapse during follow-up

Other: No intervention
Retrospective analysis

Outcome Measures

Primary Outcome Measures

  1. Event-free survival [Up to 5 years]

Secondary Outcome Measures

  1. Overall survival [Up to 5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 61 Years
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Angers University Hospital Angers France

Sponsors and Collaborators

  • University Hospital, Angers

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Angers
ClinicalTrials.gov Identifier:
NCT04931992
Other Study ID Numbers:
  • 202100042
First Posted:
Jun 18, 2021
Last Update Posted:
Jun 18, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jun 18, 2021