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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 · Not updated for over 12 months - ask the site whether it is still open

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
Local Institution - 208
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BerlinGermanyUnknown status
Local Institution - 202
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BremenGermanyUnknown status
Local Institution - 213
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CologneGermanyUnknown status
Local Institution - 205
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FrankfurtGermanyUnknown status
Local Institution - 211
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FrechenGermanyUnknown status
Local Institution - 200
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GiessenGermanyUnknown status
Local Institution - 203
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HanoverGermanyUnknown status
Local Institution - 206
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KasselGermanyUnknown status
Local Institution - 210
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MarburgGermanyUnknown status
Local Institution - 215
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MönchengladbachGermanyUnknown status
Local Institution - 204
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MünchenGermanyUnknown status
Local Institution - 212
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MünsterGermanyUnknown status
Local Institution - 201
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PotsdamGermanyUnknown status
Local Institution - 207
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RavensbergGermanyUnknown status
Local Institution - 209
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WürzburgGermanyUnknown status
Local Institution - 029
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San JuanPuerto RicoUnknown status
Summa Health System Akron City Hospital Laboratory
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AkronUnited StatesUnknown status
Local Institution - 166
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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
Local Institution - 051
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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
Local Institution - 030
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BaltimoreUnited StatesUnknown status
PeaceHealth St. Joseph Medical Center
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BellinghamUnited StatesUnknown status
Local Institution - 079
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BerkeleyUnited StatesUnknown status
Summit Medical Group Overlook Oncology Center
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Berkeley HeightsUnited StatesUnknown status
Local Institution - 050
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BolivarUnited StatesUnknown status
Local Institution - 052
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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
Local Institution - 053
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ChristiansburgUnited StatesUnknown status
Local Institution - 161
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CincinnatiUnited StatesUnknown status
Local Institution - 047
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ClevelandUnited StatesUnknown status
Local Institution - 103
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ColumbiaUnited StatesUnknown status
Local Institution - 045
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ColumbusUnited StatesUnknown status
Local Institution - 142
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ConcordUnited StatesUnknown status
Local Institution - 105
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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
Local Institution - 106
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DenverUnited StatesUnknown status
Veterans Affairs New Jersey Health Care System
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East OrangeUnited StatesUnknown status
Local Institution - 108
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Elk Grove VillageUnited StatesUnknown status
Local Institution - 080
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EnglewoodUnited StatesUnknown status
Local Institution - 059
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EugeneUnited StatesUnknown status
Local Institution - 019
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FairwayUnited StatesUnknown status
Local Institution - 068
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Fleming IslandUnited StatesUnknown status
Local Institution - 129
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Fort BelvoirUnited StatesUnknown status
Local Institution - 049
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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
Local Institution - 062
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Glenwood SpringsUnited StatesUnknown status
Local Institution - 350
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Great BendUnited StatesUnknown status
Local Institution - 073
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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
Local Institution - 159
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HinsdaleUnited StatesUnknown status
Local Institution - 026
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HoustonUnited StatesUnknown status
Local Institution - 067
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HoustonUnited StatesUnknown status
Local Institution - 008
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HoustonUnited StatesUnknown status
Broome Oncology, LLC
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Johnson CityUnited StatesUnknown status
Local Institution - 023
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KinstonUnited StatesUnknown status
Local Institution - 152
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Lake SuccessUnited StatesUnknown status
Local Institution - 033
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LansingUnited StatesUnknown status
Local Institution - 098
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LebanonUnited StatesUnknown status
Local Institution - 003
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LincolnUnited StatesUnknown status
Local Institution - 077
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Little RockUnited StatesUnknown status
Local Institution - 138
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LouisvilleUnited StatesUnknown status
Medical Oncology and Blood Disorders, LLP
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ManchesterUnited StatesUnknown status
Local Institution - 011
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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
Local Institution - 076
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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
Local Institution - 038
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MorgantownUnited StatesUnknown status
Local Institution - 025
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Mount HollyUnited StatesUnknown status
Local Institution - 301
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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
Local Institution - 083
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NewnanUnited StatesUnknown status
Local Institution - 056
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NilesUnited StatesUnknown status
Local Institution - 081
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NorfolkUnited StatesUnknown status
Local Institution - 041
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NorwalkUnited StatesUnknown status
Local Institution - 054
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OcalaUnited StatesUnknown status
Local Institution - 300
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OconomowocUnited StatesUnknown status
Local Institution - 037
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Oklahoma CityUnited StatesUnknown status
Local Institution - 119
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OlympiaUnited StatesUnknown status
Local Institution - 028
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Park RidgeUnited StatesUnknown status
Local Institution - 114
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PensacolaUnited StatesUnknown status
Local Institution - 021
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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
Local Institution - 039
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RaleighUnited StatesUnknown status
Rapid City Regional Hospital
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Rapid CityUnited StatesUnknown status
Local Institution - 164
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RochesterUnited StatesUnknown status
Associates Of Oncology/Hematology, P.C.
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RockvilleUnited StatesUnknown status
Local Institution - 071
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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
Local Institution - 090
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Salt Lake CityUnited StatesUnknown status
Local Institution - 070
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San AntonioUnited StatesUnknown status
Local Institution - 058
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San AntonioUnited StatesUnknown status
Local Institution - 032
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San DiegoUnited StatesUnknown status
Local Institution - 130
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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
Local Institution - 153
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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
Local Institution - 013
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SpringfieldUnited StatesUnknown status
Hematology Oncology Associates, PC
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StamfordUnited StatesUnknown status
Local Institution - 042
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St LouisUnited StatesUnknown status
Local Institution - 111
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TempleUnited StatesUnknown status
Toledo Clinic Cancer Center
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ToledoUnited StatesUnknown status
Local Institution - 149
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TrumbullUnited StatesUnknown status
Local Institution - 055
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TucsonUnited StatesUnknown status
Local Institution - 094
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TylerUnited StatesUnknown status
Local Institution - 163
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TylerUnited StatesUnknown status
Local Institution - 104
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VancouverUnited StatesUnknown status
Local Institution - 099
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Walla WallaUnited StatesUnknown status
Local Institution - 116
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WaterburyUnited StatesUnknown status
Cedar Valley Medical Specialists
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WaterlooUnited StatesUnknown status
Local Institution - 143
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WatervilleUnited StatesUnknown status
Local Institution - 101
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WaukeshaUnited StatesUnknown status
Local Institution - 057
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WebsterUnited StatesUnknown status
Local Institution - 006
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WenatcheeUnited StatesUnknown status

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