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NCT01996865CompletedPhase 3

Lenalidomide Plus Rituximab Followed by Lenalidomide Versus Rituximab Maintenance for Relapsed/Refractory Follicular, Marginal Zone or Mantle Cell Lymphoma.

A Phase 3B Randomized Study of Lenalidomide (CC-5013) Plus Rituximab Maintenance Therapy Followed by Lenalidomide Single-Agent Maintenance Versus Rituximab Maintenance in Subjects With Relapsed/Refractory Follicular, Marginal Zone, or Mantle Cell Lymphoma

Source: ClinicalTrials.gov · Last updated 10 Jul 2025

Brief summary (registry, in English)

Follicular lymphoma (FL), marginal zone lymphoma (MZL), and mantle cell lymphoma (MCL) are distinct histologic types of B-cell NHL. Lenalidomide is an immunomodulatory agent with direct and immune-mediated mechanisms of action, as well as clinical activity in NHL. Recent studies in frontline and relapsed/refractory NHL show high activity for lenalidomide plus rituximab (R2), supporting further study of this combination.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
503 (actual)
First submitted
22 Nov 2013
Start date
1 Apr 2014
Primary completion date
11 May 2024
Lead sponsor
Celgene
NCT number
NCT01996865

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 503
  • From 1 Apr 2014 to the primary completion date, 11 May 2024
  • 126 sites in 3 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Subjects taking corticosteroids during the last 1 week prior treatment, unless administered at a dose equivalent to \< 20 mg/day of prednisone
  • Systemic anti-lymphoma therapy within 28 days or use of antibody agents within 4 weeks use of radioimmunotherapy within 3 months

Other illness

  • Any medical condition (other than the underlying lymphoma) that requires chronic steroid use
  • Known seropositive for or active viral infection with hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV)
  • Known sensitivity or allergy to murine products
  • Presence or history of central nervous system involvement by lymphoma. Subjects who are at a risk for a thromboembolic event and are not willing to take prophylaxis for it
  • Any condition that places the subject at unacceptable risk if he/she were to participate in the study or that confounds the ability to interpret data from the study
    • Other protocol-defined inclusion/exclusion criteria apply

Other

  • Histology other than follicular or marginal zone lymphoma or clinical evidence of transformation or Grade 3b follicular lymphoma

Who the study is looking for

  • \-- Age ≥18 years
  • Histologically confirmed Follicular Lymphoma (FL, Grade 1, 2, 3a, or 3b), Transformed FL, Marginal Zone Lymphoma, or Mantle Cell Lymphoma
  • Must have documented relapsed, refractory or Progressive Disease after last treatment with systemic therapy
  • Bi-dimensionally measurable disease
  • Eastern Cooperative Oncology Group (ECOG) Performance status \< 2
  • Adequate bone marrow function
  • Willingness to follow pregnancy precautions

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (126)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
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BerlinGermanyUnknown status
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BremenGermanyUnknown status
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CologneGermanyUnknown status
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FrankfurtGermanyUnknown status
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FrechenGermanyUnknown status
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GiessenGermanyUnknown status
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HanoverGermanyUnknown status
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KasselGermanyUnknown status
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MarburgGermanyUnknown status
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MönchengladbachGermanyUnknown status
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MünchenGermanyUnknown status
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MünsterGermanyUnknown status
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PotsdamGermanyUnknown status
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RavensbergGermanyUnknown status
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WürzburgGermanyUnknown status
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San JuanPuerto RicoUnknown status
Summa Health System Akron City Hospital Laboratory
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AkronUnited StatesUnknown status
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AmarilloUnited StatesUnknown status
McFarland Clinic
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AmesUnited StatesUnknown status
Anne Arundel Medical Center
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AnnapolisUnited StatesUnknown status
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Ann ArborUnited StatesUnknown status
Arlington Cancer Center
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ArlingtonUnited StatesUnknown status
Texas Oncology-Arlington South
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ArlingtonUnited StatesUnknown status
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BaltimoreUnited StatesUnknown status
PeaceHealth St. Joseph Medical Center
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BellinghamUnited StatesUnknown status
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BerkeleyUnited StatesUnknown status
Summit Medical Group Overlook Oncology Center
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Berkeley HeightsUnited StatesUnknown status
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BolivarUnited StatesUnknown status
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BoulderUnited StatesUnknown status
Brookdale University Hospital and Medical Center
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BrooklynUnited StatesUnknown status
Aultman Hospital
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CantonUnited StatesUnknown status
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ChristiansburgUnited StatesUnknown status
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CincinnatiUnited StatesUnknown status
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ClevelandUnited StatesUnknown status
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ColumbiaUnited StatesUnknown status
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ColumbusUnited StatesUnknown status
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ConcordUnited StatesUnknown status
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DallasUnited StatesUnknown status
Praxair Cancer Center Danbury
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DanburyUnited StatesUnknown status
Colorado Cancer Research Program
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DenverUnited StatesUnknown status
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DenverUnited StatesUnknown status
Veterans Affairs New Jersey Health Care System
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East OrangeUnited StatesUnknown status
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Elk Grove VillageUnited StatesUnknown status
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EnglewoodUnited StatesUnknown status
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EugeneUnited StatesUnknown status
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FairwayUnited StatesUnknown status
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Fleming IslandUnited StatesUnknown status
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Fort BelvoirUnited StatesUnknown status
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Gig HarborUnited StatesUnknown status
C.R. Wood Cancer Center at Glens Falls Hospital
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Glens FallsUnited StatesUnknown status
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Glenwood SpringsUnited StatesUnknown status
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Great BendUnited StatesUnknown status
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GreenvilleUnited StatesUnknown status
Kentucky Cancer Clinic
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HazardUnited StatesUnknown status
United States Department of Veterans Affairs - VA Great Lakes Health Care System - Edward Hines Jr
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HinesUnited StatesUnknown status
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HinsdaleUnited StatesUnknown status
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HoustonUnited StatesUnknown status
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HoustonUnited StatesUnknown status
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HoustonUnited StatesUnknown status
Broome Oncology, LLC
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Johnson CityUnited StatesUnknown status
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KinstonUnited StatesUnknown status
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Lake SuccessUnited StatesUnknown status
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LansingUnited StatesUnknown status
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LebanonUnited StatesUnknown status
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LincolnUnited StatesUnknown status
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Little RockUnited StatesUnknown status
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LouisvilleUnited StatesUnknown status
Medical Oncology and Blood Disorders, LLP
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ManchesterUnited StatesUnknown status
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MariettaUnited StatesUnknown status
Hematology Oncology Associates, P.C.
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MedfordUnited StatesUnknown status
Baptist Cancer Center
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MemphisUnited StatesUnknown status
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MemphisUnited StatesUnknown status
Mount Sinai Comprehensive Cancer Center
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Miami BeachUnited StatesUnknown status
Aurora Health Care Aurora Research
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MilwaukeeUnited StatesUnknown status
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MorgantownUnited StatesUnknown status
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Mount HollyUnited StatesUnknown status
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MukwonagoUnited StatesUnknown status
American Health Network of Indiana, LLC
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New AlbanyUnited StatesUnknown status
Saint Peter's University Hospital
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New BrunswickUnited StatesUnknown status
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NewnanUnited StatesUnknown status
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NilesUnited StatesUnknown status
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NorfolkUnited StatesUnknown status
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NorwalkUnited StatesUnknown status
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OcalaUnited StatesUnknown status
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OconomowocUnited StatesUnknown status
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Oklahoma CityUnited StatesUnknown status
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OlympiaUnited StatesUnknown status
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Park RidgeUnited StatesUnknown status
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PensacolaUnited StatesUnknown status
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PlanoUnited StatesUnknown status
Bay Area Cancer Research Group, LLC
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Pleasant HillUnited StatesUnknown status
Cancer Treatment Center of America
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PortsmouthUnited StatesUnknown status
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RaleighUnited StatesUnknown status
Rapid City Regional Hospital
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Rapid CityUnited StatesUnknown status
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RochesterUnited StatesUnknown status
Associates Of Oncology/Hematology, P.C.
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RockvilleUnited StatesUnknown status
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Round RockUnited StatesUnknown status
Rutland Regional Medical Center
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RutlandUnited StatesUnknown status
Sutter Hematology and Oncology
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SacramentoUnited StatesUnknown status
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Salt Lake CityUnited StatesUnknown status
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San AntonioUnited StatesUnknown status
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San AntonioUnited StatesUnknown status
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San DiegoUnited StatesUnknown status
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Santa BarbaraUnited StatesUnknown status
Seattle Cancer Care Alliance
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SeattleUnited StatesUnknown status
Siouxland Hematology - Oncology Associates, LLP
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Sioux CityUnited StatesUnknown status
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Sioux FallsUnited StatesUnknown status
Orchard Healthcare Research Inc.
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SkokieUnited StatesUnknown status
Spartanburg Regional Healthcare System - Gibbs Cancer Center & Research Institute
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SpartanburgUnited StatesUnknown status
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SpringfieldUnited StatesUnknown status
Hematology Oncology Associates, PC
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StamfordUnited StatesUnknown status
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St LouisUnited StatesUnknown status
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TempleUnited StatesUnknown status
Toledo Clinic Cancer Center
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ToledoUnited StatesUnknown status
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TrumbullUnited StatesUnknown status
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TucsonUnited StatesUnknown status
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TylerUnited StatesUnknown status
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TylerUnited StatesUnknown status
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VancouverUnited StatesUnknown status
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Walla WallaUnited StatesUnknown status
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WaterburyUnited StatesUnknown status
Cedar Valley Medical Specialists
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WaterlooUnited StatesUnknown status
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WatervilleUnited StatesUnknown status
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WaukeshaUnited StatesUnknown status
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WebsterUnited StatesUnknown status
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WenatcheeUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.