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

NCT06592846 | Completed

• 1 other identifier: FERTILE
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 27

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.

Conditions

DLBCL - Diffuse Large B Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 0 from date of questionnaire signature

Secondary Outcomes (3)

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

  Day 0 from date of questionnaire signature

• Identify predictive factors associated with gonadal dysfunction.

  Day 0 from the questionnaire signature

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

  Day 0 from date of questionnaire signature

Eligibility Criteria

• Age: 18 Years - 38 Years
• Gender Eligibility Details: The subjects are women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• The subjects are women
• Participation in one of the following clinical trials: LNH 03 1B or LNH 03 2B or LNH 07 3B or GAINED
• Treated with R-ACVBP or R-CHOP14/R-CHOP21 in these clinical trials
• No relapse of their diffuse large B-cell lymphoma
• Possible use of stem cell transplantation during clinical trials
• Subjects are still alive today

You may not qualify if:

• Subjects died
• Subjects lost to follow-up

Sponsors & Collaborators

• The Lymphoma Academic Research Organisation: lead

Study Sites (27)

CH d'Avignon - Hôpital Henri Duffaut

Avignon, 84000, France

Location

Institut d'Hématologie de Basse Normandie (IHBN)

Caen, 14033, France

Location

APHP - Hôpital Henri Mondor

Créteil, 94010, France

Location

CHU de Dijon - Hôpital François Mitterand

Dijon, 21079, France

Location

CHD de Vendée

La Roche-sur-Yon, 85925, France

Location

Groupe Hospitalier La Rochelle-Ré-Aunis

La Rochelle, 17019, France

Location

CHU de Grenoble - Hôpital Albert Michallon

La Tronche, 38700, France

Location

CH de Versailles - Hôpital André Mignot

Le Chesnay, 78157, France

Location

CH St Vincent de Paul

Lille, 59020, France

Location

CHRU de Lille - Hôpital Claude Huriez

Lille, 59037, France

Location

CHU de Limoges - Hôpital Universitaire Dupuytren

Limoges, 87042, France

Location

Centre Léon Bérard

Lyon, 69373, France

Location

CHU de Montpellier

Montpellier, 34295, France

Location

CHU de Nantes

Nantes, 44093, France

Location

CHU d'Orléans

Orléans, 45067, France

Location

APHP - Hôpital Saint Louis

Paris, 75475, France

Location

APHP - Hôpital de la Pitié Salpétrière

Paris, 75651, France

Location

APHP - Hôpital Necker

Paris, 75743, France

Location

CHU Lyon Sud

Pierre-Bénite, 69495, France

Location

CHU de Poitiers - Hôpital de la Milétrie

Poitiers, 86021, France

Location

CH Annecy Genevois

Pringy, 74374, France

Location

CHU de Reims - Hôpital Robert Debré

Reims, 51100, France

Location

Centre Henri Becquerel

Rouen, 76038, France

Location

CHU de Saint Etienne_I.CHU.SE

Saint-Priest-en-Jarez, 42270, France

Location

IUCT Oncopole de Toulouse

Toulouse, 31100, France

Location

CHU de Nancy - Hôpital de Brabois

Vandœuvre-lès-Nancy, 54511, France

Location

Institut Gustave Roussy

Villejuif, 94085, France

Location

Related Publications (4)

• 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.

  PMID: 23235801 BACKGROUND

• 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.

  PMID: 22118442 BACKGROUND

• 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.

  PMID: 28701367 BACKGROUND

• 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.

  PMID: 33211799 BACKGROUND

MeSH Terms

Conditions

Dendritic Cell Sarcoma, Interdigitating

Condition Hierarchy (Ancestors)

Histiocytic Disorders, Malignant; Neoplasms by Histologic Type; Neoplasms; Histiocytosis; Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Lucie OBERIC, MD

  Institut Universitaire du Cancer Toulouse - Oncopole

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2024
• First Posted: September 19, 2024
• Study Start: September 30, 2024
• Primary Completion: January 15, 2025
• Study Completion: January 15, 2025
• Last Updated: July 22, 2025

Record last verified: 2025-01

Locations

FR (27)