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

NCT ID: NCT06592846

Last Updated: 2025-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-09-30

Study Completion Date

2025-01-15

Brief Summary

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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

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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

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DLBCL - Diffuse Large B Cell Lymphoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The Lymphoma Academic Research Organisation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lucie OBERIC, MD

Role: PRINCIPAL_INVESTIGATOR

Institut Universitaire du Cancer Toulouse - Oncopole

Locations

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CH d'Avignon - Hôpital Henri Duffaut

Avignon, , France

Site Status

Institut d'Hématologie de Basse Normandie (IHBN)

Caen, , France

Site Status

APHP - Hôpital Henri Mondor

Créteil, , France

Site Status

CHU de Dijon - Hôpital François Mitterand

Dijon, , France

Site Status

CHD de Vendée

La Roche-sur-Yon, , France

Site Status

Groupe Hospitalier La Rochelle-Ré-Aunis

La Rochelle, , France

Site Status

CHU de Grenoble - Hôpital Albert Michallon

La Tronche, , France

Site Status

CH de Versailles - Hôpital André Mignot

Le Chesnay, , France

Site Status

CH St Vincent de Paul

Lille, , France

Site Status

CHRU de Lille - Hôpital Claude Huriez

Lille, , France

Site Status

CHU de Limoges - Hôpital Universitaire Dupuytren

Limoges, , France

Site Status

Centre Léon Bérard

Lyon, , France

Site Status

CHU de Montpellier

Montpellier, , France

Site Status

CHU de Nantes

Nantes, , France

Site Status

CHU d'Orléans

Orléans, , France

Site Status

APHP - Hôpital Saint Louis

Paris, , France

Site Status

APHP - Hôpital de la Pitié Salpétrière

Paris, , France

Site Status

APHP - Hôpital Necker

Paris, , France

Site Status

CHU Lyon Sud

Pierre-Bénite, , France

Site Status

CHU de Poitiers - Hôpital de la Milétrie

Poitiers, , France

Site Status

CH Annecy Genevois

Pringy, , France

Site Status

CHU de Reims - Hôpital Robert Debré

Reims, , France

Site Status

Centre Henri Becquerel

Rouen, , France

Site Status

CHU de Saint Etienne_I.CHU.SE

Saint-Priest-en-Jarez, , France

Site Status

IUCT Oncopole de Toulouse

Toulouse, , France

Site Status

CHU de Nancy - Hôpital de Brabois

Vandœuvre-lès-Nancy, , France

Site Status

Institut Gustave Roussy

Villejuif, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 23235801 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22118442 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28701367 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33211799 (View on PubMed)

Other Identifiers

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FERTILE

Identifier Type: -

Identifier Source: org_study_id

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