NCT06592846

FERtility After Therapy With Intensive Lymphoma in Young Women: LNH-03 1B, LNH-03 2B, LNH-07 3B, GAINED Follow-up

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 80 (actual)
• Sponsor: The Lymphoma Academic Research Organisation · Academic / Other
• Sex: Female
• Age: 18 Years – 38 Years
• Healthy volunteers: Not accepted

Summary

The FERTILE study is a retrospective cohort study evaluating fertility after intensive treatment with RCHOP14/RCHOP21 or ACVBP in young patients with diffuse large B-cell lymphoma treated in clinical trials conducted by the LYSA group and still alive several years after the end of the trial.

Detailed description

The FERTILE study is a retrospective cohort study evaluating fertility after intensive treatment with RCHOP14/RCHOP21 or ACVBP in young patients (≤ 38 years) with diffuse large B-cell lymphoma treated in 4 clinical trials conducted by the LYSA group and still alive several years after the end of the trial. Chemotherapy treatments used to treat diffuse large B-cell lymphoma in women of childbearing age may cause loss of fertility. There are few studies dedicated specifically to women treated for non-Hodgkin's lymphoma, particularly in the context of intensive CHOP-based regimens (R-CHOP14/R-CHOP21/R-ACVBP). These studies do not provide any details on the type of treatment and the clinical characteristics of the patients. It is in this context that we propose the FERTILE study. This study is based on the collection and reuse of data already available in the LNH03-1B, LNH03-2B, LNH07-3B and GAINED clinical trials such as the age of the patients, the treatments, the diagnosis. The results of hormonal assessments and fertility tests (endovaginal ultrasound) will also be consulted in the medical file. In addition, a questionnaire concerning fertility will be proposed by the physician-investigator.

Conditions

• DLBCL - Diffuse Large B Cell Lymphoma

Timeline

• Start date: 2024-09-30
• Primary completion: 2025-01-15
• Completion: 2025-01-15
• First posted: 2024-09-19
• Last updated: 2025-07-22

Locations

27 sites across 1 country: France