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New hope for lymphoma: combining targeted therapy with radiation

NCT ID NCT05929222

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 09, 2026 · Updated 2 times

Summary

This phase 3 trial is testing whether adding the targeted drug obinutuzumab to standard radiotherapy improves outcomes for people with early-stage follicular lymphoma. About 190 participants will be randomly assigned to receive either radiotherapy alone or radiotherapy followed by obinutuzumab. The main goal is to see if the combination extends the time without the cancer returning.

What this could mean

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

Active substance
obinutuzumab
What this could lead to
If successful, this could offer a more effective treatment for early-stage follicular lymphoma, potentially delaying or preventing recurrence.
What could go wrong
This is a phase 3 trial, but results may not confirm a significant benefit. Adding obinutuzumab may increase side effects without improving outcomes.

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

About 190 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2023

Expected to finish

Apr 2031

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. Histological documented diagnosis of Follicular Lymphoma grade I-IIIA as defined in the 2017 edition of World Health Organization (WHO) 2. Ann Arbor Stage IA or IIA (includible in one radiation field), or IE, non-bulky (\<7 cm). Stage must be determined by PET/CT scan (Appendix 2) 3. Patients performing PET before surgery can also be enrolled without repeating PET after surgery 4. No previous treatment except for steroid pre-treatment 5. FLIPI \< 2, FLIPI2 ≤ 2 6. Age ≥ 18 years 7. Negative bone marrow biopsy 8. Qualitative/quantitative PCR centralized assessment of BCL2/IGH positive cells in peripheral blood (PB), bone marrow (BM). 9. Centralized revision of the lymph node biopsy with FISH for t(14;18) 10. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2 11. At least one site of measurable nodal disease pre-biopsy ≥ 2.0 cm in the longest transverse diameter as determined by CT scan or ultrasonography 12. Adequate renal function defined as follows: * Creatinine clearance ≥ 40 mL/min (Cockcroft-Gault formula) 13. Adequate hepatic function per local laboratory reference range as follows: * Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3.0 x UNL * Bilirubin ≤1.5 x UNL (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin) 14. Subject understands and voluntarily signs an informed consent form approved by an Independent National Ethics Committee (NEC), prior to the initiation of any screening or study-specific procedures 15. Subject must be able to adhere to the study visit schedule and other protocol requirements 16. Life expectancy ≥ 3 months 17. Fertility and pregnancy prevention criteria * Women must be: * postmenopausal for at least 1 year (must not have had a natural menses for at least 12 months) * surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy), * completely abstinent (periodic abstinence from intercourse is not permitted) or if sexually active, be practicing a highly effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double barrier method (e.g.: condoms, diaphragm, or cervical cap, with spermicidal foam, cream, or gel, male partner sterilization) as local regulations permit, before entry, and must agree to continue to use the same method of contraception throughout the study. They must also be pre-pared to continue birth control measures for at least 18 months after terminating treatment. * Women of childbearing potential must have a negative pregnancy test at screening * Men with female partners of childbearing potential: men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of \< 1% per year during the treatment period and for at least 3 months after the last dose of study treatment. Men must refrain from donating sperm for the same period * Male even if surgically sterilized (i.e., status post vasectomy) must agree to 1 of the following * practice effective barrier contraception during the entire study treatment period and through 3 months after the last dose of study drug, or * agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject. (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 of Follicular lymphoma grade IIIb 2. Staging \>II or B symptoms or bulky disease (\> 7 cm) 3. Stage II with distant involved sites, not includible in a single radiation field 4. Primary cutaneous follicular lymphoma 5. Known HIV positivity 6. Positive serology for hepatitis C (HC) defined as a positive test for HCAb, in which case reflexively perform a HC RNA on the same sample to confirm the result, if negative, the patient is eligible. 7. Positive serology for Hepatitis B (HB) defined as a positive test for HBsAg. In addition, if negative for HBsAg but HBcAb positive (regardless of HBsAb status), a quantitative HBVDNA test will be performed and if positive the subject will be excluded. Patients with HBcAb positivity and negative HBV DNA should be prophylactically treated with oral Lamivudine (100 mg /day). Note: subjects with serologic evidence of prior vaccination to HBV (i.e., hepatitis B surface (HBs) antigen negative, anti-HBs antibody positive and anti-hepatitis B core (HBc) antibody negative) or positive anti-HBc antibody from intravenous immunoglobulins (IVIG) may participate 8. Central Nervous System (CNS) involvement with lymphoma 9. Significant history of neurologic, psychiatric, endocrinological, metabolic, immunologic, or hepatic disease that would preclude participation in the study or compromise ability to give informed consent 10. Any history of other active malignancies within 3 years prior to study entry, except for adequately treated in situ carcinoma of the cervix uterine, basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin, previous malignancy confined and surgically resected with curative intent 11. Evidence of other clinically significant uncontrolled condition(s) including, but not limited to: * Uncontrolled and/or active systemic infection (viral, bacterial or fungal) * Chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment. 12. If female, the patient is pregnant or breast-feeding 13. Patients participating in other clinical studies.

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Conditions

The condition(s) this trial relates to.

follicular lymphoma lymphoma Neoplasm, Residual

As listed by the trial registrant

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

Follicular lymphoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    49 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AORN San Giuseppe Moscati Avellino, U.O.C. Ematologia e Trapianto Emopoietico

    RECRUITING

    Avellino, Italy

  • ARNAS G. Brotzu, SC Ematologia e CTMO

    NOT_YET_RECRUITING

    Cagliari, Italy

  • ASL Roma 1, UOSD Ematologia

    RECRUITING

    Roma, Italy

  • ASST Grande Ospedale Metropolitano Niguarda, SC Ematologia

    RECRUITING

    Milan, Italy

  • Azienda Ospealiero Universitaria Policlinico Umberto I, Istituto Ematologia -Dipartimento di Medicina Traslazionale e di Precisione

    RECRUITING

    Roma, Italy

  • Azienda Ospedali Riuniti Papardo-Piemonte, U.O. Ematologia

    RECRUITING

    Messina, Italy

  • Azienda Ospedaliera Nazionale Ss Antonio E Biagio E C Arrigo, SCDU Ematologia

    RECRUITING

    Alessandria, Italy

  • Azienda Ospedaliera Ospedale Di Circolo E Fondazione Macchi, U.O.C Ematologia

    RECRUITING

    Varese, Italy

  • Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello, Oncoematologia

    RECRUITING

    Palermo, Italy

  • Azienda Ospedaliera S Gerardo Di Monza, Ematologia

    RECRUITING

    Monza, Italy

  • Azienda Ospedaliera S Giovanni Addolorata, UOC Ematologia

    NOT_YET_RECRUITING

    Roma, Italy

  • Azienda Ospedaliera S Maria Di Terni, S.C. Oncoematologia

    NOT_YET_RECRUITING

    Terni, Italy

  • Azienda Ospedaliera Santa Croce E Carle, S.C. di Ematologia

    RECRUITING

    Cuneo, Italy

  • Azienda Ospedaliera Universitaria Federico II Di Napoli, U.O.C. di Ematologia e Trapianti di Midollo

    RECRUITING

    Naples, Italy

  • Azienda Ospedaliera Universitaria Integrata Verona, U.O.C. Ematologia

    RECRUITING

    Verona, Italy

  • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone, U.O.C. Ematologia

    NOT_YET_RECRUITING

    Palermo, Italy

  • Azienda Ospedaliera Universitaria Senese, U.O.C. Ematologia

    RECRUITING

    Siena, Italy

  • Azienda Ospedaliero Universitaria Di Modena, S.C. Ematologia

    RECRUITING

    Modena, Italy

  • Azienda Ospedaliero Universitaria Pisana, U.O. Ematologia

    RECRUITING

    Pisa, Italy

  • Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco Di Catania, UOC Ematologia

    RECRUITING

    Catania, Italy

  • Azienda Ospedaliero-Universitaria Maggiore Della Carita, SCDU Ematologia

    RECRUITING

    Novara, Italy

  • Azienda Ospedaliero-Universitaria Sant Andrea, UOC Ematologia

    RECRUITING

    Roma, Italy

  • Azienda Sanitaria Universitaria Friuli Centrale, SOC Clinica Ematologica

    RECRUITING

    Udine, Italy

  • Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia, U.O. Ematologia

    RECRUITING

    Brescia, Italy

  • Azienda Socio Sanitaria Territoriale Della Valtellina E Dell Alto Lario, Medicina Interna

    RECRUITING

    Sondrio, Italy

  • Azienda USL IRCCS Di Reggio Emilia, S.C. Ematologia

    RECRUITING

    Reggio Emilia, Italy

  • Azienda Unita Sanitaria Locale Della Romagna, U.O. di Ematologia

    RECRUITING

    Rimini, Italy

  • Azienda Unita Sanitaria Locale Della Romagna, U.O.C. Ematologia

    RECRUITING

    Ravenna, Italy

  • Azienda Unita' Locale Socio Sanitaria N. 2 Marca Trevigiana, S.C di Ematologia

    RECRUITING

    Treviso, Italy

  • Azienda Unità Sanitaria Locale Di Piacenza, U.O.Ematologia

    RECRUITING

    Piacenza, Italy

  • Careggi University Hospital, SOD Ematologia

    RECRUITING

    Florence, Italy

  • Catholic University Of Sacred Heart, UOC Ematologia e Trapianto di cellule staminali emopoietiche

    RECRUITING

    Roma, Italy

  • Centro Di Riferimento Oncologico Di Aviano, S.O.C. Oncologia Medica e dei Tumori Immunocorrelati

    RECRUITING

    Aviano, Italy

  • Fondazione IRCCS Istituto Nazionale Dei Tumori, S.C. Ematologia e Trapianto Midollo Osseo Allogenico

    RECRUITING

    Milan, Italy

  • Fondazione IRCCS Policlinico San Matteo, U.O.C. Ematologia I

    NOT_YET_RECRUITING

    Pavia, Italy

  • Fondazione Policlinico Universitario Campus Bio-Medico, UOC di Ematologia e Trapianto di Cellule Staminali

    RECRUITING

    Roma, Italy

  • Hospital Santa Maria Della Misericordia, S.C. di Ematologia con TMO

    RECRUITING

    Perugia, Italy

  • I.F.O. Istituti Fisioterapici Ospitalieri, UOSD Ematologia e Trapianto

    RECRUITING

    Roma, Italy

  • Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS, Oncologia Medica

    RECRUITING

    Candiolo, Italy

  • Istituto Oncologico Veneto, U.O.C. Oncoematologia

    RECRUITING

    Castelfranco Veneto, Italy

  • Istituto Oncologico Veneto, UOC Oncologia 1

    RECRUITING

    Padova, Italy

  • Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l., Oncoematologia

    RECRUITING

    Meldola, Italy

  • Istituto Tumori Bari Giovanni Paolo II, U.O. di Ematologia e Terapia Cellulare

    RECRUITING

    Bari, Italy

  • Nuovo Ospedale Civile di Sassuolo - Day Hospital Oncologico

    RECRUITING

    Sassuolo, Modena (MO), 41049, Italy

  • Ospedale Di Sassuolo S.p.A., U.O.S.D. di Oncologia

    RECRUITING

    Sassuolo, Italy

  • Ospedale San Raffaele S.r.l., Unitа Linfomi - Dipartimento Oncoematologia

    RECRUITING

    Milan, Italy

  • Ospedale Santa Maria Goretti, SOD Ematologia

    RECRUITING

    Latina, Italy

  • Ospedale degli Infermi di Biella, SSD Ematologia

    RECRUITING

    Biella, Italy

  • Ssd Ematologia ASLTO4, S.S.D. Ematologia

    NOT_YET_RECRUITING

    Ivrea, Italy

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