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Follicular LymphomaPhase 3RELEVANCENCT01650701

A Phase 3 Open Label Randomized Study to Compare the Efficacy and Safety of Rituximab Plus Lenalidomide (CC-5013) Versus Rituximab Plus Chemotherapy Followed by Rituximab in Subjects With Previously Untreated Follicular Lymphoma

A Phase 3 study testing Rituximab, Lenalidomide and Rituximab - CHOP in people with Follicular Lymphoma, run by The Lymphoma Academic Research Organisation at 35 sites in 8 countries.

Completed

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

Official record
Search all trials

Trial summary

The purpose of this study is to find out if lenalidomide when given along with rituximab can help to control the disease and also increase the length of your response (complete or partial response) compared to the standard of care rituximab chemotherapy treatment. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Follicular Lymphoma
What is being tested?
Rituximab, Lenalidomide and Rituximab - CHOP
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,030 participants
Where
35 sitesin 8 countries
Study dates
Feb 2012to 30 Apr 2024
Phase
Phase 3
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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.
Show all 16Show fewer
  • 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.

Trial locations and contacts

35 sites in 8 countries.

35 sites in 8 countries

Canada12 sites

  • Tom Baker Cancer Centre

    Calgary, Alberta

  • Cross Cancer Institute

    Edmonton, Alberta

  • Atlantic Health Sciences Corp - Saint John Regional Hospital

    Halifax, Nova Scotia

  • Moncton Hospital

    Moncton, New Brunswick

  • CHUM Hopital Notre-Dame

    Montreal, Quebec

  • McGill University Department of Oncology

    Montreal, Quebec

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

    Québec, Quebec

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan

  • Fraser Valley Cancer Centre

    Surrey, British Columbia

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario

  • UHN-Princess Margaret Hospital

    Toronto, Ontario

  • BCCA - Vancouver Cancer Centre

    Vancouver, British Columbia

Other trials in Canada

Spain12 sites

  • Hospital Clínico de Barcelona

    Barcelona

  • Hospital de la Santa Creu i Sant Pau

    Barcelona

  • Hospital Universitario Vall d´Hebron

    Barcelona

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

    Girona

  • Hospital Ramon y Cajal

    Madrid

  • Hospital Costa del Sol

    Marbella

  • Hospital Son Llatzer

    Palma, Mallorca

  • Hospital Universitario Salamanca

    Salamanca

  • Hospital Universitario de Canarias

    Santa Cruz de Tenerife, Canary Islands

  • Hospital Virgen del Rocio

    Seville, Andaloucia

  • Hospital Universitario Mutua de Terrassa

    Terrassa, Barcelona

  • Hospital Clínico Universitario de Valencia

    Valencia

Other trials in Spain

Australia3 sites

  • Concord Repatriation General Hospital

    Concord, New South Wales

  • Nepean Hospital

    Penrith, New South Wales

  • Wollongong Hospital

    Wollongong, New South Wales

Other trials in Australia

Germany3 sites

  • Uniklinik Köln

    Cologne, Nordrhein

  • LMU Munchën - Klinikum Grosshadern

    München

  • Medizinische Klinik der Universität Tübingen

    Tübingen, Baden-Wurttemberg

Other trials in Germany

Italy2 sites

  • Policlinico Sant'Orsola-Malpighi

    Bologna

  • Sant'Andrea Hospital

    Rome, Lazio

Other trials in Italy

Belgium1 site

  • CHU Mont-Godinne

    Yvoir

Other trials in Belgium

France1 site

  • CHU Claude Huriez

    Lille

Other trials in France

Portugal1 site

  • Instituto Português Oncologia

    Lisbon

Other trials in Portugal

About this study

Official title: A PHASE 3 OPEN-LABEL RANDOMIZED STUDY TO COMPARE THE EFFICACY AND SAFETY OF RITUXIMAB PLUS LENALIDOMIDE (CC-5013) VERSUS RITUXIMAB PLUS CHEMOTHERAPY FOLLOWED BY RITUXIMAB IN SUBJECTS WITH PREVIOUSLY UNTREATED FOLLICULAR LYMPHOMA The "RELEVANCE" Trial (Rituximab Lenalidomide Versus ANy ChEmotherapy)is Being Conducted as Two Companion Studies: RV-FOL-GELARC-0683 (N=750) and RV-FOL-GELARC-0683C (N=250); the Combined Total of 1000 Patients Enrolled in Both Studies Will be Analyzed.

The purpose of this study is to find out if lenalidomide when given along with rituximab can help to control the disease and also increase the length of your response (complete or partial response) compared to the standard of care rituximab chemotherapy treatment.

Read the detailed description

Follicular Lymphoma (FL) is a cancer of a B lymphocyte, a type of white blood cell. FL is typically a slowly progressing but incurable disease. Follicular lymphoma cells produce a specific defect in the patient's immune system impairing their ability to control their cancer. Lenalidomide has been shown to reverse the specific immune defect caused by FL in the patient. By including lenalidomide, the RELEVANCE study aims to eliminate the cancer while restoring the patient's immune competence.

Being tested
Rituximab, Lenalidomide, Rituximab - CHOP, Rituximab - CVP, Rituximab - Bendamustine
Keywords
follicular lymphoma, non-hodgkins follicular lymphoma, treatment for follicular lymphoma, rituximab treatment, rituximab and lenalidomide treatment
Medical subject headings
Lymphoma, Follicular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RituximabDrug

    Also called mabthera, rituxan

    • Rituximab, 375 mg/m2 on days 1, 8, 15 and 22 of cycle 1, day 1 of cycles 2 to 6; 8 weeks later responding patients continue with 375 mg/m2 rituximab every 8 weeks for 12 cycles.

  • LenalidomideDrug

    Also called Revlimid

    • Lenalidomide dose 20-mg on days 2-22 every 28 days x 6 cycles, if CR then 10-mg on days 2-22 every 28 days for 12 cycles. PR after 6 cycles, continue 20 mg for 3~6 cycles and then 10 mg on days 2-22 every 28-day cycles for upto 18 cycles

  • Rituximab - CHOPDrug

    six cycles of R-CHOP in 21 day cycles followed by two 21 day cycles of 375 mg/m2 rituximab; and 7 weeks later responding patients continue with 375 mg/m2 rituximab every 8 weeks for 12 cycles

  • Rituximab - CVPDrug

    eight cycles of R-CVP in 21 day cycles; and 7 weeks later responding patients continue with 375 mg/m2 rituximab every 8 weeks for 12 cycles,

  • Rituximab - BendamustineDrug

    six cycles of R-B in 28 day cycles and 8 weeks later responding patients continue with 375 mg/m2 rituximab every 8 weeks for 12 cycles.

Study groups in NCT01650701
Study groupRoleWhat they receive
Lenalidomide + RituximabExperimental* Lenalidomide dose 20-mg on days 2-22 every 28 days x 6 cycles, if CR then 10-mg on days 2-22 every 28 days for 12 cycles. PR after 6 cycles, continue 20 mg for 3~6 cycles and then 10 mg on days 2-22 every 28-day cycles for upto 18 cycles * Rituximab, 375 mg/m2 on days 1, 8, 15 and 22 of cycle 1, day 1 of cycles 2 to 6; 8 weeks later responding patients continue with 375 mg/m2 rituximab every 8 weeks for 12 cycles.
Receives: Drug: Rituximab; Drug: Lenalidomide
ControlActive comparator• ONE of the following: Rituximab - CHOP, Rituximab - CVP, Rituximab - Bendamustine. 7 to 8 weeks later responding patients will continue with 375 mg/m2 rituximab every 8 weeks for 12 cycles.
Receives: Drug: Rituximab - CHOP; Drug: Rituximab - CVP; Drug: Rituximab - Bendamustine

What is being measured

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

  1. COMPLETE RESPONSE RATE

    Complete response (CR/CRu) rate at 120 weeks Response evaluation was as defined by International Working Group (IWG) Response Criteria (Cheson 1999). Complete response (CR) is defined as the complete disappearance of all detectable clinical and radiographic evidence of disease and the disappearance of all disease-related symptoms if present before therapy.

    Measured: Timeframe: CR/CRu rate at 120 weeks

  2. Progression Free Survival (PFS)

    PFS is defined as the time from the start of study drug therapy to the 1st observation of disease progression or death due to any cause.

    Measured: up to 13 years

Secondary outcomes (8)

  1. Number of participants with adverse events

    Measured: up to13 years

  2. Time to Treatment Failure (TTF)

    Measured: up to13 years

  3. Event Free Survival (EFS)

    Measured: up to13 years

  4. Time to Next Anti-Lymphoma Treatment (TTNLT),

    Measured: up to13 years

  5. Time to Next Chemotherapy Treatment (TTNCT)

    Measured: up to13 years

  6. Overall Survival (OS)

    Measured: up to13 years

  7. Overall response rate at 120 weeks by International Working Group (IWG) 1999 criteria

    Measured: up to13 years

  8. Health related quality of life as measured by the EORTC QLQ-C30

    Measured: up to13 years

Timeline

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

  1. First posted26 Jul 2012 (estimated)
  2. Study startFeb 2012
  3. Primary completion31 May 2017
  4. Study completion30 Apr 2024

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,030 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01650701
Sponsor's protocol ID
RV-FOL-GELARC-0683
Other IDs
2011-002792-42
Acronym
RELEVANCE
Status last verified
Sep 2025
First submitted
24 Jul 2012
Last updated
25 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Gower N, Feugier P, Westin J, Schiano De Colella JM, Tilly H, Palomba ML, Julia E, Damaj GL, Durand A, Flinn I, Lemonnier F, Morineau N, Ysebaert L, Bartlett N, Thieblemont C, Ribrag V, Gastinne T, Dony A, Fouillet L, Guidez S, Houot R, Da Silva MG, Barnes J, Bijou F, Cartron G, Garcia-Sancho AM, Eradat H, Cheminant M, Guillermo AL, Abrisqueta P, Abraham J, Sarkozy C, Izutsu K, Crochet G, Sehn LH, Gkasiamis A, Yge ML, Chartier L, Fowler N, Xerri L, Salles G, Morschhauser F. Lenalidomide plus rituximab for previously untreated advanced follicular lymphoma: the 10-year RELEVANCE trial analysis. Blood. 2026 Jun 18;147(25):3061-3068. doi: 10.1182/blood.2026033126.

    PubMed 41915772

  • Claudel A, Cottereau AS, Bachy E, Itti E, Feugier P, Rossi C, Lemonnier F, Camus V, Daguindau N, Cartron G, Nicolas-Virelizier E, Mboumba DL, Cardoso C, Bommier C, Tessoulin B, Fruchart C, Gilbert A, Durot E, Fleck E, Pica GM, Zerazhi H, Guidez S, Cheminant M, Sarkozy C, Xerri L, Vercellino L, Trabelsi N, Gomes L, Portugues C, Viailly PJ, Delfau-Larue MH, Morschhauser F. Combined PET and ctDNA response as a predictor of POD24 for follicular lymphoma after first-line induction treatment. Blood. 2025 Aug 21;146(8):913-925. doi: 10.1182/blood.2024027727.

    PubMed 40499012

  • Laurent C, Trisal P, Tesson B, Seth S, Beyou A, Roulland S, Lesne B, Van Acker N, Cerapio JP, Chartier L, Guille A, Stokes ME, Huang CC, Huet S, Gandhi AK, Morschhauser F, Xerri L. Follicular lymphoma comprises germinal center-like and memory-like molecular subtypes with prognostic significance. Blood. 2024 Dec 12;144(24):2503-2516. doi: 10.1182/blood.2024024496.

    PubMed 39374535

  • Morschhauser F, Nastoupil L, Feugier P, Schiano de Colella JM, Tilly H, Palomba ML, Bachy E, Fruchart C, Libby EN, Casasnovas RO, Flinn IW, Haioun C, Maisonneuve H, Ysebaert L, Bartlett NL, Bouabdallah K, Brice P, Ribrag V, Le Gouill S, Daguindau N, Guidez S, Pica GM, Garcia-Sancho AM, Lopez-Guillermo A, Larouche JF, Ando K, Gomes da Silva M, Andre M, Kalung W, Sehn LH, Izutsu K, Cartron G, Gkasiamis A, Crowe R, Xerri L, Fowler NH, Salles G. Six-Year Results From RELEVANCE: Lenalidomide Plus Rituximab (R2) Versus Rituximab-Chemotherapy Followed by Rituximab Maintenance in Untreated Advanced Follicular Lymphoma. J Clin Oncol. 2022 Oct 1;40(28):3239-3245. doi: 10.1200/JCO.22.00843. Epub 2022 Aug 10.

    PubMed 35947804

  • Delfau-Larue MH, Boulland ML, Beldi-Ferchiou A, Feugier P, Maisonneuve H, Casasnovas RO, Lemonnier F, Pica GM, Houot R, Ysebaert L, Tilly H, Eisenmann JC, Le Gouill S, Ribrag V, Godmer P, Glaisner S, Cartron G, Xerri L, Salles GA, Fest T, Morschhauser F. Lenalidomide/rituximab induces high molecular response in untreated follicular lymphoma: LYSA ancillary RELEVANCE study. Blood Adv. 2020 Aug 11;4(14):3217-3223. doi: 10.1182/bloodadvances.2020001955.

    PubMed 32673385

  • Morschhauser F, Fowler NH, Feugier P, Bouabdallah R, Tilly H, Palomba ML, Fruchart C, Libby EN, Casasnovas RO, Flinn IW, Haioun C, Maisonneuve H, Ysebaert L, Bartlett NL, Bouabdallah K, Brice P, Ribrag V, Daguindau N, Le Gouill S, Pica GM, Martin Garcia-Sancho A, Lopez-Guillermo A, Larouche JF, Ando K, Gomes da Silva M, Andre M, Zachee P, Sehn LH, Tobinai K, Cartron G, Liu D, Wang J, Xerri L, Salles GA; RELEVANCE Trial Investigators. Rituximab plus Lenalidomide in Advanced Untreated Follicular Lymphoma. N Engl J Med. 2018 Sep 6;379(10):934-947. doi: 10.1056/NEJMoa1805104.

    PubMed 30184451

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rituximab, Lenalidomide and Rituximab - CHOP in people with Follicular Lymphoma, run by The Lymphoma Academic Research Organisation at 35 sites in 8 countries.

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 9 inclusion and 16 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 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in Canada, Spain, Australia, Germany, Italy and 3 more countries. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

COMPLETE RESPONSE RATE (time frame: Timeframe: CR/CRu rate at 120 weeks). The study lists 2 primary outcomes in all. 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 NCT01650701, which also lists 6 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 25 Sep 2025.

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