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
NCT ID: NCT01650701
Last Updated: 2025-09-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1030 participants
INTERVENTIONAL
2012-02-29
2024-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Lenalidomide + Rituximab
* 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.
Rituximab
• 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.
Lenalidomide
• 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
Control
• 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.
Rituximab - CHOP
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 - CVP
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 - Bendamustine
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.
Interventions
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Rituximab
• 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.
Lenalidomide
• 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 - CHOP
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 - CVP
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 - Bendamustine
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Celgene Corporation
INDUSTRY
The Lymphoma Academic Research Organisation
OTHER
Responsible Party
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Principal Investigators
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Franck Morschhauser, MD, PhD
Role: STUDY_CHAIR
The Lymphoma Study Association (LYSA)
Locations
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Concord Repatriation General Hospital
Concord, New South Wales, Australia
Nepean Hospital
Penrith, New South Wales, Australia
Wollongong Hospital
Wollongong, New South Wales, Australia
CHU Mont-Godinne
Yvoir, , Belgium
Tom Baker Cancer Centre
Calgary, Alberta, Canada
Cross Cancer Institute
Edmonton, Alberta, Canada
Fraser Valley Cancer Centre
Surrey, British Columbia, Canada
BCCA - Vancouver Cancer Centre
Vancouver, British Columbia, Canada
Moncton Hospital
Moncton, New Brunswick, Canada
Atlantic Health Sciences Corp - Saint John Regional Hospital
Halifax, Nova Scotia, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
UHN-Princess Margaret Hospital
Toronto, Ontario, Canada
CHUM Hopital Notre-Dame
Montreal, Quebec, Canada
McGill University Department of Oncology
Montreal, Quebec, Canada
Hôpital de l'Enfant-Jesus, CHU de Quebec
Québec, Quebec, Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada
CHU Claude Huriez
Lille, , France
Medizinische Klinik der Universität Tübingen
Tübingen, Baden-Wurttemberg, Germany
Uniklinik Köln
Cologne, Nordrhein, Germany
LMU Munchën - Klinikum Grosshadern
München, , Germany
Sant'Andrea Hospital
Rome, Lazio, Italy
Policlinico Sant'Orsola-Malpighi
Bologna, , Italy
Instituto Português Oncologia
Lisbon, , Portugal
Hospital Virgen del Rocio
Seville, Andaloucia, Spain
Hospital Universitario Mutua de Terrassa
Terrassa, Barcelona, Spain
Hospital Universitario de Canarias
Santa Cruz de Tenerife, Canary Islands, Spain
Hospital Son Llatzer
Palma, Mallorca, Spain
Hospital Clínico de Barcelona
Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Universitario Vall d´Hebron
Barcelona, , Spain
Institut Català d'Oncologia de Girona (ICO Girona)
Girona, , Spain
Hospital Ramon y Cajal
Madrid, , Spain
Hospital Costa del Sol
Marbella, , Spain
Hospital Universitario Salamanca
Salamanca, , Spain
Hospital Clínico Universitario de Valencia
Valencia, , Spain
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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2011-002792-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
RV-FOL-GELARC-0683
Identifier Type: -
Identifier Source: org_study_id
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