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

• Conditions: Acute Myeloid Leukemia

• Registration Number: NCT04679285
• Lead Sponsor: University Hospital, Lille

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-16
• Study First Submitted QC: 2020-12-21
• Study First Posted: 2020-12-22
• Status Verified: 2021-04
• Study Start: 2021-04-26
• Last Update Submitted: 2021-04-27
• Last Update Posted: 2021-04-29
• Primary Completion: 2021-11
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 8

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.

Exclusion Criteria

• Other diagnostic
• No marker available at AML diagnosis
• No bone marrow/ovarian fragment available at the time of complete remission

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of patients without detectable MRD in ovarian tissue	Up to 6 months

Secondary Outcome Measures

Name	Time	Method
Percentage of patients with MRD detected in ovarian tissue and bone marrow.	Up to 1 month

Trial Locations

Locations (1)

CHU lille; 🇫🇷 Lille, France