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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Identify the predictive factors associated with pregnancy success after intensive chemotherapy treatment. | Identification of predictive factors associated with pregnancy after lymphoma treatment, assessed by a Cox proportional hazards model. | Day 0 from date of questionnaire signature |
| Identify predictive factors associated with gonadal dysfunction. |
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Inclusion Criteria:
Exclusion Criteria:
The subjects are women
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
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| Name | Affiliation | Role |
|---|---|---|
| Lucie OBERIC, MD | Institut Universitaire du Cancer Toulouse - Oncopole | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH d'Avignon - Hôpital Henri Duffaut | Avignon | 84000 | France | |||
| Institut d'Hématologie de Basse Normandie (IHBN) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22118442 | 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. | |
| 28701367 |
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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). |
| Day 0 from the questionnaire signature |
| Study the different clinical practices concerning the preservation of fertility in LYSA sites. | 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) | Day 0 from date of questionnaire signature |
| Caen |
| 14033 |
| France |
| APHP - Hôpital Henri Mondor | Créteil | 94010 | France |
| CHU de Dijon - Hôpital François Mitterand | Dijon | 21079 | France |
| CHD de Vendée | La Roche-sur-Yon | 85925 | France |
| Groupe Hospitalier La Rochelle-Ré-Aunis | La Rochelle | 17019 | France |
| CHU de Grenoble - Hôpital Albert Michallon | La Tronche | 38700 | France |
| CH de Versailles - Hôpital André Mignot | Le Chesnay | 78157 | France |
| CH St Vincent de Paul | Lille | 59020 | France |
| CHRU de Lille - Hôpital Claude Huriez | Lille | 59037 | France |
| CHU de Limoges - Hôpital Universitaire Dupuytren | Limoges | 87042 | France |
| Centre Léon Bérard | Lyon | 69373 | France |
| CHU de Montpellier | Montpellier | 34295 | France |
| CHU de Nantes | Nantes | 44093 | France |
| CHU d'Orléans | Orléans | 45067 | France |
| APHP - Hôpital Saint Louis | Paris | 75475 | France |
| APHP - Hôpital de la Pitié Salpétrière | Paris | 75651 | France |
| APHP - Hôpital Necker | Paris | 75743 | France |
| CHU Lyon Sud | Pierre-Bénite | 69495 | France |
| CHU de Poitiers - Hôpital de la Milétrie | Poitiers | 86021 | France |
| CH Annecy Genevois | Pringy | 74374 | France |
| CHU de Reims - Hôpital Robert Debré | Reims | 51100 | France |
| Centre Henri Becquerel | Rouen | 76038 | France |
| CHU de Saint Etienne_I.CHU.SE | Saint-Priest-en-Jarez | 42270 | France |
| IUCT Oncopole de Toulouse | Toulouse | 31100 | France |
| CHU de Nancy - Hôpital de Brabois | Vandœuvre-lès-Nancy | 54511 | France |
| Institut Gustave Roussy | Villejuif | 94085 | France |
| 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. |
| 33211799 | 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. |
| 23235801 | Result | 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. |
| ID | Term |
|---|---|
| D054739 | Dendritic Cell Sarcoma, Interdigitating |
| ID | Term |
|---|---|
| D015620 | Histiocytic Disorders, Malignant |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D015614 | Histiocytosis |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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