DLBCL - Diffuse Large B Cell Lymphoma
Conditions
Brief 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.
Interventions
None listed
Sponsors
The Lymphoma Academic Research Organisation
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 38 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Day 0 from date of questionnaire signature | The fertility rate: spontaneous pregnancy rate (with live births) among young women who wish to have children. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Identify the predictive factors associated with pregnancy success after intensive chemotherapy treatment. | Day 0 from date of questionnaire signature | Identification of predictive factors associated with pregnancy after lymphoma treatment, assessed by a Cox proportional hazards model. |
| Identify predictive factors associated with gonadal dysfunction. | Day 0 from the questionnaire signature | 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). |
| Study the different clinical practices concerning the preservation of fertility in LYSA sites. | Day 0 from date of questionnaire signature | 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) |
Countries
France
Outcome results
None listed