NCT04931992

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2021

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

June 8, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 18, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

June 18, 2021

Status Verified

June 1, 2021

Enrollment Period

7 months

First QC Date

June 8, 2021

Last Update Submit

June 14, 2021

Conditions

Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

  • Event-free survival

    Up to 5 years

Secondary Outcomes (1)

  • Overall survival

    Up to 5 years

Study Arms (3)

Molecular relapse

Confirmed molecular relapse, without overt cytological relapse

Other: No intervention

Cytological relapse

Overt cytological relapse, without prior molecular relapse

Other: No intervention

Persistent responders

No molecular or cytological relapse during follow-up

Other: No intervention

Interventions

No interventionOTHER

Retrospective analysis

Cytological relapseMolecular relapsePersistent responders

Eligibility Criteria

Age18 Years - 61 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • Acute promyelocytic leukemia
  • Allogeneic stem cell transplantation in CR1

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Angers University Hospital

Angers, France

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Central Study Contacts

Corentin Orvain, MD, PhD

CONTACT

+33241354475corentin.orvain@chu-angers.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2021

First Posted

June 18, 2021

Study Start

June 1, 2021

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

June 18, 2021

Record last verified: 2021-06

Locations

FR(1)