Clinical trial · Observational
FERtility After Therapy With Intensive Lymphoma in Young Women: LNH-03 1B, LNH-03 2B, LNH-07 3B, GAINED Follow-up
NCT06592846CI-TRIAL-00092424FERTILEcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| DLBCL - Diffuse Large B Cell Lymphoma | Interdigitating Dendritic Cell Sarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- 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
- description
- The fertility rate: spontaneous pregnancy rate (with live births) among young women who wish to have children.
Secondary outcomes (3)
- measure
- Identify the predictive factors associated with pregnancy success after intensive chemotherapy treatment.
- timeFrame
- Day 0 from date of questionnaire signature
- description
- Identification of predictive factors associated with pregnancy after lymphoma treatment, assessed by a Cox proportional hazards model.
- measure
- Identify predictive factors associated with gonadal dysfunction.
- timeFrame
- Day 0 from the questionnaire signature
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 38 Years
Show eligibility criteria text
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
References
Publications (4)
- BACKGROUNDRecher 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
- BACKGROUNDCasasnovas 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
- BACKGROUNDLe 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
- RESULTKetterer 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