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AzTrials

DLBCL - Diffuse Large B Cell LymphomaFERTILENCT06592846

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

An observational study of DLBCL - Diffuse Large B Cell Lymphoma, run by The Lymphoma Academic Research Organisation at 27 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 38 years, women only
Conditions the study is for
DLBCL - Diffuse Large B Cell Lymphoma
How many people
80 participants
Where
27 sitesFrance
Study dates
30 Sep 2024to 15 Jan 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 38 years
  • Women only
  • No healthy volunteers
  • Adult

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

Who may be able to join

  • 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
  • Age at initial diagnosis between 18 years and 38 years inclusive, which has allowed their inclusion in the clinical trial
  • 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

Who cannot join

  • Subjects died
  • Subjects lost to follow-up

Trial locations and contacts

27 sites in 1 country.

27 sites in 1 country

France27 sites

  • CH d'Avignon - Hôpital Henri Duffaut

    Avignon, 84000

  • Institut d'Hématologie de Basse Normandie (IHBN)

    Caen, 14033

  • APHP - Hôpital Henri Mondor

    Créteil, 94010

  • CHU de Dijon - Hôpital François Mitterand

    Dijon, 21079

  • CHD de Vendée

    La Roche-sur-Yon, 85925

  • Groupe Hospitalier La Rochelle-Ré-Aunis

    La Rochelle, 17019

  • CHU de Grenoble - Hôpital Albert Michallon

    La Tronche, 38700

  • CH de Versailles - Hôpital André Mignot

    Le Chesnay, 78157

  • CH St Vincent de Paul

    Lille, 59020

  • CHRU de Lille - Hôpital Claude Huriez

    Lille, 59037

  • CHU de Limoges - Hôpital Universitaire Dupuytren

    Limoges, 87042

  • Centre Léon Bérard

    Lyon, 69373

  • CHU de Montpellier

    Montpellier, 34295

  • CHU de Nantes

    Nantes, 44093

  • CHU d'Orléans

    Orléans, 45067

  • APHP - Hôpital Saint Louis

    Paris, 75475

  • APHP - Hôpital de la Pitié Salpétrière

    Paris, 75651

  • APHP - Hôpital Necker

    Paris, 75743

  • CHU Lyon Sud

    Pierre-Bénite, 69495

  • CHU de Poitiers - Hôpital de la Milétrie

    Poitiers, 86021

  • CH Annecy Genevois

    Pringy, 74374

  • CHU de Reims - Hôpital Robert Debré

    Reims, 51100

  • Centre Henri Becquerel

    Rouen, 76038

  • CHU de Saint Etienne_I.CHU.SE

    Saint-Priest-en-Jarez, 42270

  • IUCT Oncopole de Toulouse

    Toulouse, 31100

  • CHU de Nancy - Hôpital de Brabois

    Vandœuvre-lès-Nancy, 54511

  • Institut Gustave Roussy

    Villejuif, 94085

Other trials in France

About this study

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.

Read the detailed description

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.

Medical subject headings
Dendritic Cell Sarcoma, Interdigitating

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Day 0 from date of questionnaire signature

Secondary outcomes (3)

  1. 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.

    Measured: Day 0 from date of questionnaire signature

  2. Identify predictive factors associated with gonadal dysfunction.

    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).

    Measured: Day 0 from the questionnaire signature

  3. 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)

    Measured: Day 0 from date of questionnaire signature

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start30 Sep 2024
  3. Primary completion15 Jan 2025
  4. Study completion15 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06592846
Sponsor's protocol ID
FERTILE
Acronym
FERTILE
Status last verified
Jan 2025
First submitted
28 Aug 2024
Last updated
22 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 22118442

  • 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.

    PubMed 28701367

  • 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.

    PubMed 33211799

  • 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.

    PubMed 23235801

Questions about this trial

What is this clinical trial studying?

An observational study of DLBCL - Diffuse Large B Cell Lymphoma, run by The Lymphoma Academic Research Organisation at 27 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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. (time frame: Day 0 from date of questionnaire signature). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06592846, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2025; AzTrials last refreshed its copy on 8 Nov 2026.

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