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

The Lymphoma Academic Research Organisation80 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

DLBCL - Diffuse Large B Cell Lymphoma

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 38 Years

Medical Language ↔ Plain English

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

Locations (27)

CH d'Avignon - Hôpital Henri Duffaut

Avignon, France

Outcomes

Primary Outcomes

Study fertility by evaluating the rate of spontaneous pregnancy (with live-born children) in women (≤ 38 years) treated for diffuse large B-cell lymphoma in 4 LYSA clinical trials.

The fertility rate: spontaneous pregnancy rate (with live births) among young women who wish to have children.

Time frame: Day 0 from date of questionnaire signature

Secondary Outcomes

Identify the predictive factors associated with pregnancy success after intensive chemotherapy treatment.

Identification of predictive factors associated with pregnancy after lymphoma treatment, assessed by a Cox proportional hazards model.

Time frame: Day 0 from date of questionnaire signature

Identify predictive factors associated with gonadal dysfunction.

The identification of predictive factors associated with gonadal dysfunction after lymphoma treatment, assessed by a Cox proportional hazards model. Methods used to assess ovarian reserve (biochemical tests including basal levels of including basal levels of FSH, LH, estradiol and antimüllerian hormone; ultrasound estradiol and antimüllerian hormone; ultrasound measurements including number of antral follicles and ovarian volume).

Time frame: Day 0 from the questionnaire signature

Study the different clinical practices concerning the preservation of fertility in LYSA sites.

Fertility preservation techniques used in the centres (ovarian stimulation, cryopreservation of ovarian tissue, GnRH agonists, in vitro maturation). Methods used to assess ovarian reserve (biochemical tests including basal levels of including basal levels of FSH, LH, estradiol and antimüllerian hormone; ultrasound estradiol and antimüllerian hormone; ultrasound measurements including number of antral follicles and ovarian volume)

Time frame: Day 0 from date of questionnaire signature

Data from ClinicalTrials.gov

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