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New Pill-and-Antibody combo may replace chemo for common lymphoma

NCT ID NCT01650701

Disease control Sponsor: The Lymphoma Academic Research Organisation 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tested whether a combination of two drugs (rituximab and lenalidomide) works better than standard chemotherapy plus rituximab for people with untreated follicular lymphoma, a slow-growing blood cancer. About 1,030 adults with advanced disease who needed treatment took part. The goal was to see if the new combo could control the disease longer and improve response rates without the side effects of chemo.

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

1,030 people

The number who actually took part.

Started

Feb 2012

Finished

Apr 2024

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: * Histologically confirmed CD20+ follicular lymphoma grade 1, 2 or 3a * Have no prior systemic treatment for lymphoma. * Must be in need of treatment * Bi-dimensionally measurable disease with at least one mass lesion \> 2 cm that was not previously irradiated. * Stage II, III or IV disease. * Must be ≥ 18 years and sign an informed consent. * Performance status ≤ 2 on the ECOG scale. * Adequate hematological function (unless abnormalities are related to lymphoma infiltration of the bone marrow) * Willing to follow pregnancy precautions Exclusion Criteria: * Clinical evidence of transformed lymphoma by investigator assessment or Grade 3b follicular lymphoma. * Patients taking corticosteroids during the last 4 weeks, unless administered at a dose equivalent to \< 10 mg/day prednisone (over these 4 weeks). * Major surgery (excluding lymph node biopsy) within 28 days prior to signing informed consent. * Known Seropositive for or active viral infection with hepatitis B virus (HBV), hepatitis C virus (HCV)or human immunodeficiency virus (HIV). * Life expectancy \< 6 months. * Known sensitivity or allergy to murine products. * Prior history of malignancies, other than follicular lymphoma, unless the patient has been free of the disease for ≥ 10 years. * Prior use of lenalidomide. * Neuropathy \> Grade 1. * Presence or history of CNS involvement by lymphoma. * Patients 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 patients with documented liver or pancreatic involvement by lymphoma * total bilirubin \> 2.0 mg/dl (34 µmol/L) except in cases of Gilberts Syndrome and documented liver involvement by lymphoma * creatinine clearance of \< 30 mL/min * Pregnant or lactating females. * Any condition, including the presence of laboratory abnormalities, which places the patient 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

As listed by the trial registrant

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

Follicular lymphoma

Contacts and locations

Locations

  • Atlantic Health Sciences Corp - Saint John Regional Hospital

    Halifax, Nova Scotia, Canada

  • BCCA - Vancouver Cancer Centre

    Vancouver, British Columbia, Canada

  • CHU Claude Huriez

    Lille, France

  • CHU Mont-Godinne

    Yvoir, Belgium

  • CHUM Hopital Notre-Dame

    Montreal, Quebec, Canada

  • Concord Repatriation General Hospital

    Concord, New South Wales, Australia

  • Cross Cancer Institute

    Edmonton, Alberta, Canada

  • Fraser Valley Cancer Centre

    Surrey, British Columbia, Canada

  • Hospital Clínico Universitario de Valencia

    Valencia, Spain

  • Hospital Clínico de Barcelona

    Barcelona, Spain

  • Hospital Costa del Sol

    Marbella, Spain

  • Hospital Ramon y Cajal

    Madrid, Spain

  • Hospital Son Llatzer

    Palma, Mallorca, Spain

  • Hospital Universitario Mutua de Terrassa

    Terrassa, Barcelona, Spain

  • Hospital Universitario Salamanca

    Salamanca, Spain

  • Hospital Universitario Vall d´Hebron

    Barcelona, Spain

  • Hospital Universitario de Canarias

    Santa Cruz de Tenerife, Canary Islands, Spain

  • Hospital Virgen del Rocio

    Seville, Andaloucia, Spain

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Spain

  • Hôpital de l'Enfant-Jesus, CHU de Quebec

    Québec, Quebec, Canada

  • Institut Català d'Oncologia de Girona (ICO Girona)

    Girona, Spain

  • Instituto Português Oncologia

    Lisbon, Portugal

  • LMU Munchën - Klinikum Grosshadern

    München, Germany

  • McGill University Department of Oncology

    Montreal, Quebec, Canada

  • Medizinische Klinik der Universität Tübingen

    Tübingen, Baden-Wurttemberg, Germany

  • Moncton Hospital

    Moncton, New Brunswick, Canada

  • Nepean Hospital

    Penrith, New South Wales, Australia

  • Policlinico Sant'Orsola-Malpighi

    Bologna, Italy

  • Sant'Andrea Hospital

    Rome, Lazio, Italy

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan, Canada

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, Canada

  • Tom Baker Cancer Centre

    Calgary, Alberta, Canada

  • UHN-Princess Margaret Hospital

    Toronto, Ontario, Canada

  • Uniklinik Köln

    Cologne, Nordrhein, Germany

  • Wollongong Hospital

    Wollongong, New South Wales, Australia

More trials for these conditions

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