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New combo therapy aims to keep lymphoma in check longer

NCT ID NCT02390869

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 20, 2026 · Updated 2 times

Summary

This phase 3 trial tests whether adding lenalidomide to rituximab maintenance therapy works better than rituximab alone for people with relapsed follicular lymphoma who cannot have a stem cell transplant. About 128 participants will receive either the combination or rituximab alone after initial chemoimmunotherapy. The goal is to see if the combination delays cancer progression and is safe.

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

128 people

The number who actually took part.

Started

May 2014

Expected to finish

Aug 2027

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: * Follicular lymphoma grade I, II and IIIa according to the WHO classification. Rebiopsy at study entry is strongly encouraged but mandatory only in case of suspected transformation (elevated LDH or rapidly-growing disease or unusual relapse presentation). * First or second relapse or progression following R-chemotherapy (Rituximab maintenance and IF radiotherapy are not considered treatment lines). * Previous treatment with Bendamustine can be considered eligible if relapse occurred after ≥ 24 months. * Age \>18 years. * Patients not eligible for high dose chemotherapy and ASCT because of: age ≥ 65 years, impaired PS or organ function due to major comorbidities or relapsed or refractory disease after previous ASCT before 65 of age. * Stage II, III or IV according to Ann Arbor at relapse. * Need of treatment according to SIE-SIES-GITMO guidelines for follicular lymphoma: stage II-IV with systemic symptoms, high tumor burden (i.e. \>3 lymph nodes measuring \>3 cm or a single lymph node \>7 cm), extranodal disease, cytopenia due to marrow involvement, spleen involvement (≥16 cm by CT), leukemic phase, serious effusion, symptomatic or life endangering organ involvement, rapid lymphoma progression, consistently increased LDH levels. * Must be able to adhere to the study visit schedule and other protocol standards. * ECOG performance status ≤ 2 (except when PS impairment is related to lymphoma). * Be willing and able to comply with the protocol for the duration of the study. * Absolute neutrophil count (ANC) ≥ 1.5 x 10 9/L unless due to marrow involvement by lymphoma; and platelets count ≥ 75 x 109/L unless due to marrow involvement by lymphoma. * Calculated creatinine clearances ≥ 40 ml/min. * Agree to be using effective contraception for the entire treatment period according to standard guidelines for patients receiving lenalidomide Exclusion Criteria: * Any lymphoma subtype other than FL including transformed FL * Grade 3b follicular lymphoma. * Radiotherapy within 3 months prior to study entry * Major surgery (excluding lymph node biopsy) within 28 days prior to registration. * HIV positive serology. HBV and HCV positive patients will be not excluded from the study if the hepatic enzymes are within the ranges later defined. HBV occult carriers patients will be given lamivudine as prophylaxis starting one week before chemotherapy. HbsAg, HBcAb, HBV-DNA and HCV-RNA levels will be monitored twice every month in HCV or HBV positive patients. * Life expectancy \< 6 months. * Known sensitivity or allergy to murine products. * Prior history of malignancies, other than follicular lymphoma, unless the subject has been free of the disease for \> 3 years with the exception of adequately cured localized non-melanoma skin cancer, carcinoma in situ of the cervix, carcinoma in situ of the breast or incidental histological finding of prostate cancer (TNM stage of T1a or T1b) * Prior use of lenalidomide. * Neuropathy \> Grade 1. * Myocardial infarction within the last 6 months * Presence or history of CNS involvement by lymphoma. * Subjects who are at a high risk for a thromboembolic event and are not willing to take venous thromboembolic (VTE) prophylaxis. * Serum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT) \> 3x upper limit of normal (ULN), except in subjects with documented liver involvement by lymphoma * Total bilirubin \> 2.0 mg/dl (34 umol/L) except in cases of Gilberts Syndrome and documented liver involvement by lymphoma * Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form. * Pregnant or lactating females. * Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study, or which confounds the ability to interpret data from the study.

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Conditions

The condition(s) this trial relates to.

follicular lymphoma Recurrence

As listed by the trial registrant

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

Lymphoma, follicular

Contacts and locations

Locations

  • A O Papardo

    Messina, Italy

  • A.O. S. Maria di Terni

    Terni, TR, 05100, Italy

  • A.O. Universitaria Careggi Di Firenze

    Florence, 50139, Italy

  • A.O. Universitaria Citta' Della Salute E Della Scienza Di Torino

    Torino, 10126, Italy

  • A.O. Universitaria Ospedale Vittorio Emanuele E Ferrarotto Di Catania

    Catania, 95124, Italy

  • A.O. Universitaria Policlinico Di Modena

    Modena, 41124, Italy

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

    Torino, Italy

  • A.S.L. 9 Opsedali Riuniti del Canavese

    Ivrea, Italy

  • AO Arcispedale S.Maria Nuova Ematologia

    Reggio Emilia, Italy

  • AO Santa Croce e Carle

    Cuneo, 12100, Italy

  • AOU La Sapienza

    Roma, 00161, Italy

  • AOU Maggiore della Carità di Novara

    Novara, 28100, Italy

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, MI, 20162, Italy

  • ASST Valle Olona - Ospedale di Circolo di Busto Arsizio

    Busto Arsizio, Varese, Italy

  • AUSL di Ravenna

    Ravenna, RA, 48100, Italy

  • Area Vasta Romagna e IRST

    Meldola (FC), Italy

  • Ausl Di Piacenza

    Piacenza, 29121, Italy

  • Centro di riferimento Oncologico - Oncologia Medica A

    Aviano (PN), Italy

  • Divisione di Ematologia Spedali Civili

    Brescia, Italy

  • Ematologia - OSPEDALE DI CIRCOLO E FONDAZIONE MACCHI

    Varese, 21100, Italy

  • Fondazione Del Piemonte Per L'Oncologia Ircc Di Candiolo

    Candiolo, Torino, 10060, Italy

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, Italy

  • IRCCS Istituto Oncologico Veneto -Oncologia 1

    Padova, Italy

  • Nuovo Ospedale Civile di Sassuolo - Day Hospital Oncologico

    Sassuolo, Italy

  • Ospedale C. e G. Mazzoni UOS Ematologia

    Ascoli Piceno, Italy

  • Ospedale S. Giacomo di Castelfranco Veneto

    Castelfranco Veneto, Treviso, 31033, Italy

  • Ospedale SS Antonio Biagio e Cesare Arrigo

    Alessandria, Italy

  • SOS Ematologia Divisione Medicina Interna Ospedale degli Infermi

    Biella, Italy

More trials for these conditions

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