FERTILAM: Minimal Residual Disease Evaluation on Cryopreserved Ovarian Fragments in Younger Patients Treated for Acute Myeloid Leukemia

Sponsor

University Hospital, Lille (Other)

Overall Status

Recruiting

CT.gov ID

NCT04679285

Collaborator

Canceropôle Nord Ouest (Other), Saint-Louis Hospital, Paris, France (Other)

Enrollment

Location

7.2

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Cryopreservation of ovarian cortex represents an option for fertility preservation in patients diagnosed with acute myeloid leukemia and requiring allogeneic stem cell transplantation.

This pilot study aims to evaluate the minimal residual disease on ovarian fragments harvested before allogeneic stem cell transplantation at the time of complete remission.

Condition or Disease	Intervention/Treatment	Phase
Acute Myeloid Leukemia

Study Design

Study Type:

Observational

Anticipated Enrollment :

8 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

Pilot Study to Assess Minimal Residual Disease on Cryopreserved Ovarian Fragments in Younger Patients Treated for Acute Myeloid Leukemia

Actual Study Start Date :

Apr 26, 2021

Anticipated Primary Completion Date :

Nov 1, 2021

Anticipated Study Completion Date :

Dec 1, 2021

Outcome Measures

Primary Outcome Measures

Percentage of patients without detectable MRD in ovarian tissue [Up to 6 months]

Secondary Outcome Measures

Percentage of patients with MRD detected in ovarian tissue and bone marrow. [Up to 1 month]

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 25 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Patient diagnosed with AML
At least one molecular marker identified at AML diagnosis
Patients who undergo ovarian tissue cryopreservation for fertility preservation in complete remission, before hematopoietic stem cell transplantation.