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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04931992
Recruitment Status : Unknown
Verified June 2021 by University Hospital, Angers.
Recruitment status was:  Recruiting
First Posted : June 18, 2021
Last Update Posted : June 18, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers

Study Description
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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
Acute Myeloid Leukemia Other: No intervention

Study Design
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Study Type : Observational
Estimated 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 : June 1, 2021
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort 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
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Primary Outcome Measures :
  1. Event-free survival [ Time Frame: Up to 5 years ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: Up to 5 years ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 61 Years   (Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Adult patients < 61 years with CBF and/or NPM1-mutated AML in CR1 after induction therapy who did not receive allogeneic stem transplantation and who were followed for measurable residual disease after completion of treatment.
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04931992


Contacts
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Contact: Corentin Orvain, MD, PhD +33241354475 corentin.orvain@chu-angers.fr

Locations
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France
Angers University Hospital Recruiting
Angers, France
Contact: Corentin Orvain, MD, PhD    +33241354475    corentin.orvain@chu-angers.fr   
Sponsors and Collaborators
University Hospital, Angers
More Information
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Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT04931992    
Other Study ID Numbers: 202100042
First Posted: June 18, 2021    Key Record Dates
Last Update Posted: June 18, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No