Clinical trial NCT06592846: FERtility After Therapy with Intensive Lymphoma in Young Women: LNH-03 1B, LNH-03 2B, LNH-07 3B, GAINED Follow-up
Official title: FERtility After Therapy with Intensive Lymphoma in Young Women: LNH-03 1B, LNH-03 2B, LNH-07 3B, GAINED Follow-up
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: DLBCL - Diffuse Large B Cell Lymphoma
Lead sponsor: The Lymphoma Academic Research Organisation
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Young patients ( ≤ 38 years of age) with diffuse large B-cell lymphoma treated with intensive RCHOP or ACVBP chemotherapy in clinical trials conducted by the LYSA group, and still alive several years after the end of the the trial

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: Day 0 from date of questionnaire signature
Secondary outcomes:
measure: Identify the predictive factors associated with pregnancy success after intensive chemotherapy treatment.
timeFrame: Day 0 from date of questionnaire signature
measure: Identify predictive factors associated with gonadal dysfunction.
timeFrame: Day 0 from the questionnaire signature
measure: Study the different clinical practices concerning the preservation of fertility in LYSA sites.
timeFrame: Day 0 from date of questionnaire signature
Other outcomes:
Locations:
city: Avignon
country: France
facility: CH d'Avignon - Hôpital Henri Duffaut
city: Caen
country: France
facility: Institut d'Hématologie de Basse Normandie (IHBN)
city: Creteil
country: France
facility: APHP - Hôpital Henri Mondor
city: Dijon
country: France
facility: CHU de Dijon - Hôpital François Mitterand
city: La Roche-sur-yon
country: France
facility: CHD de Vendée
city: La Rochelle
country: France
facility: Groupe Hospitalier La Rochelle-Ré-Aunis
city: La Tronche
country: France
facility: CHU de Grenoble - Hôpital Albert Michallon
city: Le Chesnay
country: France
facility: CH de Versailles - Hôpital André Mignot
city: Lille
country: France
facility: CH St Vincent de Paul
city: Lille
country: France
facility: CHRU de Lille - Hôpital Claude Huriez
city: Limoges
country: France
facility: CHU de Limoges - Hôpital Universitaire Dupuytren
city: Lyon
country: France
facility: Centre Léon Bérard
city: Montpellier
country: France
facility: CHU de Montpellier
city: Nantes
country: France
facility: CHU de Nantes
city: Orléans
country: France
facility: CHU d'Orléans
city: Paris
country: France
facility: APHP - Hôpital Saint Louis
city: Paris
country: France
facility: APHP - Hôpital de la Pitié Salpétrière
city: Paris
country: France
facility: APHP - Hôpital Necker
city: Pierre-bénite
country: France
facility: CHU Lyon Sud
city: Poitiers
country: France
facility: CHU de Poitiers - Hôpital de la Milétrie
city: Pringy
country: France
facility: CH Annecy Genevois
city: Reims
country: France
facility: CHU de Reims - Hôpital Robert Debré
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Saint-priest-en-jarez
country: France
facility: CHU de Saint Etienne_I.CHU.SE
city: Toulouse
country: France
facility: IUCT Oncopole de Toulouse
city: Vandoeuvre-les-nancy
country: France
facility: CHU de Nancy - Hôpital de Brabois
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: Institut Universitaire du Cancer Toulouse - Oncopole
name: Lucie OBERIC, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ketterer N, Coiffier B, Thieblemont C, Ferme C, Briere J, Casasnovas O, Bologna S, Christian B, Connerotte T, Recher C, Bordessoule D, Fruchart C, Delarue R, Bonnet C, Morschhauser F, Anglaret B, Soussain C, Fabiani B, Tilly H, Haioun C. Phase III study of ACVBP versus ACVBP plus rituximab for patients with localized low-risk diffuse large B-cell lymphoma (LNH03-1B). Ann Oncol. 2013 Apr;24(4):1032-7. doi: 10.1093/annonc/mds600. Epub 2012 Dec 12.
citation: Recher C, Coiffier B, Haioun C, Molina TJ, Ferme C, Casasnovas O, Thieblemont C, Bosly A, Laurent G, Morschhauser F, Ghesquieres H, Jardin F, Bologna S, Fruchart C, Corront B, Gabarre J, Bonnet C, Janvier M, Canioni D, Jais JP, Salles G, Tilly H; Groupe d'Etude des Lymphomes de l'Adulte. Intensified chemotherapy with ACVBP plus rituximab versus standard CHOP plus rituximab for the treatment of diffuse large B-cell lymphoma (LNH03-2B): an open-label randomised phase 3 trial. Lancet. 2011 Nov 26;378(9806):1858-67. doi: 10.1016/S0140-6736(11)61040-4.
citation: Casasnovas RO, Ysebaert L, Thieblemont C, Bachy E, Feugier P, Delmer A, Tricot S, Gabarre J, Andre M, Fruchart C, Mounier N, Delarue R, Meignan M, Berriolo-Riedinger A, Bardet S, Emile JF, Jais JP, Haioun C, Tilly H, Morschhauser F. FDG-PET-driven consolidation strategy in diffuse large B-cell lymphoma: final results of a randomized phase 2 study. Blood. 2017 Sep 14;130(11):1315-1326. doi: 10.1182/blood-2017-02-766691. Epub 2017 Jul 12.
citation: Le Gouill S, Ghesquieres H, Oberic L, Morschhauser F, Tilly H, Ribrag V, Lamy T, Thieblemont C, Maisonneuve H, Gressin R, Bouhabdallah K, Haioun C, Damaj G, Fornecker L, Bouhabdallah R, Feugier P, Sibon D, Cartron G, Bonnet C, Andre M, Chartier L, Ruminy P, Kraeber-Bodere F, Bodet-Milin C, Berriolo-Riedinger A, Briere J, Jais JP, Molina TJ, Itti E, Casasnovas RO. Obinutuzumab vs rituximab for advanced DLBCL: a PET-guided and randomized phase 3 study by LYSA. Blood. 2021 Apr 29;137(17):2307-2320. doi: 10.1182/blood.2020008750.