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
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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COMPLETED
80 participants
OBSERVATIONAL
2024-09-30
2025-01-15
Brief Summary
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Detailed Description
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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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Study Design
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COHORT
RETROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
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
2. Subjects lost to follow-up
18 Years
38 Years
FEMALE
No
Sponsors
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The Lymphoma Academic Research Organisation
OTHER
Responsible Party
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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
Institut d'Hématologie de Basse Normandie (IHBN)
Caen, , France
APHP - Hôpital Henri Mondor
Créteil, , France
CHU de Dijon - Hôpital François Mitterand
Dijon, , France
CHD de Vendée
La Roche-sur-Yon, , France
Groupe Hospitalier La Rochelle-Ré-Aunis
La Rochelle, , France
CHU de Grenoble - Hôpital Albert Michallon
La Tronche, , France
CH de Versailles - Hôpital André Mignot
Le Chesnay, , France
CH St Vincent de Paul
Lille, , France
CHRU de Lille - Hôpital Claude Huriez
Lille, , France
CHU de Limoges - Hôpital Universitaire Dupuytren
Limoges, , France
Centre Léon Bérard
Lyon, , France
CHU de Montpellier
Montpellier, , France
CHU de Nantes
Nantes, , France
CHU d'Orléans
Orléans, , France
APHP - Hôpital Saint Louis
Paris, , France
APHP - Hôpital de la Pitié Salpétrière
Paris, , France
APHP - Hôpital Necker
Paris, , France
CHU Lyon Sud
Pierre-Bénite, , France
CHU de Poitiers - Hôpital de la Milétrie
Poitiers, , France
CH Annecy Genevois
Pringy, , France
CHU de Reims - Hôpital Robert Debré
Reims, , France
Centre Henri Becquerel
Rouen, , France
CHU de Saint Etienne_I.CHU.SE
Saint-Priest-en-Jarez, , France
IUCT Oncopole de Toulouse
Toulouse, , France
CHU de Nancy - Hôpital de Brabois
Vandœuvre-lès-Nancy, , France
Institut Gustave Roussy
Villejuif, , France
Countries
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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.
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.
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.
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.
Other Identifiers
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FERTILE
Identifier Type: -
Identifier Source: org_study_id
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