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

The Lymphoma Academic Research Organisation

Status: Completed

Conditions: DLBCL - Diffuse Large B Cell Lymphoma

Study type: Observational

Funder types: Other

Identifiers

NCT06592846

FERTILE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: Female

Ages: 18 to 38 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. The subjects are women
2. Participation in one of the following clinical trials: LNH 03 1B or LNH 03 2B or LNH 07 3B or GAINED
3. Age at initial diagnosis between 18 years and 38 years inclusive, which has allowed their inclusion in the clinical trial
4. Treated with R-ACVBP or R-CHOP14/R-CHOP21 in these clinical trials
5. No relapse of their diffuse large B-cell lymphoma
6. Possible use of stem cell transplantation during clinical trials
7. Subjects are still alive today

Exclusion criteria

1. Subjects died
2. Subjects lost to follow-up