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Could fewer chemo rounds be enough for follicular lymphoma?

NCT ID NCT05058404

Disease control Sponsor: Fondazione Italiana Linfomi - ETS Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 trial compares a shorter chemotherapy regimen (4 cycles) against the standard 6 cycles, both combined with immunotherapy, for people with newly diagnosed, high-tumor-burden follicular lymphoma. The goal is to see if the shorter treatment is just as effective at keeping the cancer from progressing. About 605 participants are being studied across multiple centers in Italy.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Rituximab and bendamustine (immunochemotherapy)
What this could lead to
If successful, this could mean many patients with follicular lymphoma can receive fewer chemotherapy cycles without compromising disease control, reducing side effects.
What could go wrong
This is an early-stage phase 3 trial, and the shortened regimen may prove less effective in preventing cancer progression. Results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

605 people

The number who actually took part.

Started

Dec 2021

Expected to finish

Jul 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Histologically documented diagnosis of CD20+ Follicular lymphoma grade 1-2 or 3a, as defined in the 2017 edition of the World Health Organization (WHO) classification; 2. Age ≥ 18 years; 3. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Appendix B); 4. No previous immunochemotherapy for the lymphoma (localized radiotherapy or rituximab monotherapy with max of 4 doses are allowed); 5. Ann Arbor stage II-IV (Appendix A); 6. High tumor burden as per Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria defined as the presence of at least one of the following: * systemic symptoms; * Tumor bulk (any nodal or extranodal tumor mass with diameter \> 7 cm); * involvement of ≥ 3 nodal sites, each with a diameter ≥ 3 cm; * splenomegaly; * compressive syndrome (organ compression); * serous effusion; * circulant malignant cells; * cytopenia; * Eastern Cooperative Oncology Group - Performance Status (ECOG-PS) \> 1; * Lactate dehydrogenase (LDH) \> upper limit of normality (ULN); * β2-microglobulin \> 3 mg/L. 7. At least one site of measurable nodal disease at baseline ≥ 1.5 cm in the longest transverse diameter as determined by CT scan (MRI is allowed if CT scan cannot be performed); or evaluable disease at baseline FDG-PET (18F-fluorodeoxyglucose (FDG)-Positron Emission Tomography (PET)) scan (at least one metabolic active site of disease); 8. Adequate hematological counts (unless due to bone marrow involvement by lymphoma) defined as follows: 1. Absolute Neutrophil count (ANC) \> 1.5 x 109/L; 2. Platelet count ≥ 80 x 109/L ; 3. Hemoglobin ≥ 10 g/dL. 9. Adequate renal function defined as creatinine ≤ 2 mg/dL, unless secondary to lymphoma; 10. Adequate hepatic function defined as bilirubin ≤ 2 mg/dL, unless secondary to lymphoma; 11. Left Ventricular Ejection Fraction (LVEF) \> 50% at bidimensional echocardiogram (mandatory only for patients receiving R/G-CHOP); 12. Life expectancy ≥ 6 months; 13. Subject understands and voluntarily signs an informed consent form approved by an Independent Ethics Committee (IEC) prior to the initiation of any screening or study-specific procedures; 14. Subject must be able to adhere to the study visit schedule and other protocol requirements; 15. Women of childbearing potential (WOCBP) and men must agree to use effective contraception if sexually active. This applies for the time period between signing of the informed consent form and 12 months after last rituximab dose or 18 months after last obinutuzumab dose. A woman is considered of childbearing potential, i.e. fertile, following menarche and until becoming postmenopausal unless permanently sterile. Permanent sterilization methods include but are not limited to hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for continuous 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. The investigator or a designated associate is requested to advise the patient how to achieve highly effective birth control (failure rate of less than 1%) e.g., intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner. The use of condoms by male patients is required (even if surgically sterilized, i.e., status post vasectomy) unless the female partner is permanently sterile. Full sexual abstinence is admitted when this is in line with the preferred and usual lifestyle of the subject, for the same time period planned for other methods of birth control (see above). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post ovulation methods for the female partner) and withdrawal are not acceptable methods of contraception). Exclusion Criteria: 1. Histological diagnosis different from FL grade 1-3a WHO 2017 classification; 2. Suspect or clinical evidence of Central Nervous System (CNS) involvement by lymphoma; 3. Contraindication to the use of anti-CD20 monoclonal antibodies; 4. Subject has received any anticancer therapy (chemotherapy, immunotherapy, investigational therapy, including targeted small molecule agents) within 14 days prior to the first dose of study drug; 5. Noteworthy history of neurologic, psychiatric, endocrinological, metabolic, immunologic, or hepatic disease that would preclude participation in the study or compromise ability to give informed consent; 6. Any history of other active malignancies within 3 years prior to study entry, with the exception of: adequately treated in situ carcinoma of the cervix uterine; basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin; limited stage surgically removed breast cancer or adequately treated with radiation therapy; limited stage prostate carcinoma surgically removed or adequately treated with radiation therapy; previous malignancy confined and surgically resected with curative intent; 7. Evidence of other clinically significant uncontrolled condition(s) including, but not limited to: * Uncontrolled and/or active systemic infection (viral, bacterial or fungal), including active ongoing infection from SARS-CoV-2; * Chronic or acute hepatitis B (HBV) or hepatitis C (HCV) requiring treatment. Note: subjects with serologic evidence of prior vaccination to HBV (i.e., HBsAg negative, HBsAb positive and HBcAb negative) or positive HBcAb from previous infection or intravenous immunoglobulins (IVIG) may participate; inactive carriers (HBsAg positive with undetectable HBV- DNA) are eligible. Patients with presence of HCV antibody are eligible only if Polymerase Chain Reaction (PCR) negative for HCV-RNA; 8. Women who are pregnant or breastfeeding.

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Conditions

The condition(s) this trial relates to.

follicular lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Follicular lymphoma

Contacts and locations

Locations

  • A.O. S. Croce e Carle - S.C. di Ematologia e Trapianto di Midollo Osseo

    Cuneo, Italy

  • A.O. S. Maria di Terni - S.C. Oncoematologia

    Terni, 05100, Italy

  • A.O. SS. Antonio e Biagio e Cesare Arrigo - S.C. Ematologia

    Alessandria, 15121, Italy

  • A.O.R. "San Carlo" - U.O. Ematologia

    Potenza, 85100, Italy

  • A.O.U. Citta della Salute e della Scienza di Torino - Ematologia Universitaria

    Torino, 10126, Italy

  • A.O.U. Citta della Salute e della Scienza di Torino - S.C.Ematologia

    Torino, 10126, Italy

  • AOU Maggiore della Caritа di Novara - SCDU Ematologia

    Novara, 28100, Italy

  • AOU Ospedali Riuniti - Clinica di Ematologia

    Ancona, 60126, Italy

  • AOU Pisana - U.O. Ematologia

    Pisa, 56126, Italy

  • AOU Policlinico Consorziale - U.O. Ematologia con Trapianto

    Bari, 70124, Italy

  • AOU Policlinico Giaccone - Ematologia

    Palermo, 90127, Italy

  • AOU Senese - U.O.C. Ematologia

    Siena, 53100, Italy

  • AOU di Padova - Ematologia

    Padova, Italy

  • ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia

    Milan, 20162, Italy

  • ASST MONZA Ospedale S. Gerardo - Ematologia

    Monza, Monza E Brianza, 20900, Italy

  • ASST Santi Paolo e Carlo - Onco - Ematologia

    Milan, 20153, Italy

  • ASST Valle Olona - Ospedale di Circolo di Busto Arsizio - S.C. Ematologia

    Busto Arsizio, Varese, 21052, Italy

  • Azienda Ospedali Riuniti Papardo-Piemonte - S.C. Ematologia

    Messina, 98158, Italy

  • Azienda Ospedaliera S.Giuseppe Moscati - S.C. Ematologia e Trapianto emopoietico

    Avellino, 83100, Italy

  • Azienda Ospedaliera Universitaria Careggi - Unitа funzionale di Ematologia

    Florence, 50141, Italy

  • Azienda Ospedaliera della Valtellina e della Valchiavenna P.O. Sondrio - Medicina Interna - Centro Malattie del Sangue P.O. Sondrio

    Sondrio, 23100, Italy

  • Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele Presidio Ospedale Ferrarotto - Ematologia

    Catania, 95125, Italy

  • Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant'Anna - Ematologia e fisiopatologia della coagulazione

    Ferrara, 44124, Italy

  • Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) - SC Ematologia

    Trieste, 34121, Italy

  • Azienda Unitа Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova - Ematologia

    Reggio Emilia, 42123, Italy

  • Ematologia e Trapianti A.O. San Giovanni di Dio e Ruggi D Aragona - U.O. Ematologia

    Salerno, 84131, Italy

  • Fondazione del Piemonte per l'Oncologia - IRCCS - Ematologia

    Candiolo, Torino, 10060, Italy

  • I.R.C.C.S. Istituto Oncologico Veneto - Oncologia 1

    Padova, 35128, Italy

  • IRCCS Centro di Riferimento Oncologico di Aviano - Divisione di Oncologia e dei Tumori immuto-correlati

    Aviano, Pordenone, 33081, Italy

  • IRCCS Istituto Romagnolo per lo studio dei Tumori "Dino Amadori" - IRST S.R.L. - Ematologia

    Meldola, Forlì - Cesena, 47014, Italy

  • IRCCS Policlinico S. Matteo di Pavia - Div. di Ematologia

    Pavia, 27100, Italy

  • Istituto Scientifico San Raffaele - Unitа Linfomi - Dipartimento Oncoematologia

    Milan, 20132, Italy

  • Nuovo Ospedale Civile di Sassuolo - Day Hospital Oncologico

    Sassuolo, Modena, 41049, Italy

  • Nuovo Ospedale degli Infermi - SSD Ematologia

    Biella, 13875, Italy

  • Ospedale Antonio Perrino - U.O. Ematologia e Trapianti di Midollo

    Brindisi, 72100, Italy

  • Ospedale C.e G. Mazzoni - U.O.C. di Ematologia

    Ascoli Piceno, 63100, Italy

  • Ospedale Ca Foncello - S.C di Ematologia

    Treviso, 31100, Italy

  • Ospedale Guglielmo da Saliceto - U.O.Ematologia

    Piacenza, 29121, Italy

  • Ospedale Maggiore Policlinico - Fondazione IRCCS Ca Granda - Ematologia

    Milan, Italy

  • Ospedale Policlinico San Martino S.S.R.L. - IRCCS per l Oncologia - Ematologia

    Genova, 16132, Italy

  • Ospedale S. Eugenio

    Roma, 00144, Italy

  • Ospedale S. Martino - UOC Oncologia

    Belluno, 32100, Italy

  • Ospedale S. Stefano - SOS Oncoematologia, ASL Toscana Centro

    Prato, 59100, Italy

  • Ospedale San Giovanni di Dio - SOS Ematologia clinica e oncoematologia ASL Toscana Centro

    Florence, 50143, Italy

  • Ospedale degli Infermi di Rimini - U.O. di Ematologia

    Rimini, 47923, Italy

  • Ospedale delle Croci - Ematologia

    Ravenna, 48121, Italy

  • Ospedale di Castelfranco Veneto - Ematologia

    Castelfranco Veneto, Treviso, 31033, Italy

  • P.O. Spirito Santo di Pescara - UOS Dipartimentale - Centro di diagnosi e Terapia dei linfomi

    Pescara, 65124, Italy

  • Policlinico Umberto I - Universitа "La Sapienza" - Istituto Ematologia -Dipartimento di Medicina Traslazionale e di Precisione

    Roma, 00161, Italy

  • Presidio ospedaliero "A. TORTORA" - U.O. Onco-ematologia

    Pagani, Salerno, 84016, Italy

  • U.O.C. Ematologia Ospedale Civile di Legnano

    Legnano, Milano, 20025, Italy

  • UO Ematologia e CTMO - AOU di Parma

    Parma, 43126, Italy

  • USLL13 - Dipartimento di Scienze Mediche UOC di Oncologia ed Ematologia Oncologica

    Mirano, Venezia, 30035, Italy

  • Universitа Cattolica S. Cuore - Ematologia

    Roma, 00168, Italy

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Other studies related to the condition(s) this trial covers.