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Completed Phase 3 Interventional Results available

Rituximab Plus Lenalidomide for Patients With Relapsed / Refractory Indolent Non-Hodgkin's Lymphoma (Follicular Lymphoma and Marginal Zone Lymphoma)

ClinicalTrials.gov ID: NCT01938001

Public ClinicalTrials.gov record NCT01938001. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 18, 2026, 10:10 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 3, Double-blind, Randomized Study to Compare the Efficacy and Safety of Rituximab Plus Lenalidomide (CC-5013) Versus Rituximab Plus Placebo in Subjects With Relapsed/Refractory Indolent Lymphoma

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This double-blind randomized, parallel group study will evaluate the efficacy and safety of lenalidomide (Revlimid, CC-5013) in combination with rituximab (MabThera/Rituxan) in patients with relapsed or refractory follicular lymphoma or marginal zone lymphoma. Patients will be randomized to receive either lenalidomide or placebo for twelve 28-day cycles in combination with rituximab. Anticipated time on study treatment is 1 year.

Study identification

NCT ID
NCT01938001
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Celgene
Industry
Enrollment
358 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 21, 2013 (Actual)
Primary completion
Jun 22, 2018 (Actual)
Completion
Jan 26, 2022 (Actual)
Last update posted
Feb 22, 2023

2013 – 2022

United States locations

U.S. sites
35
U.S. states
22
U.S. cities
34
Facility City State ZIP Site status
Mitchell Cancer Center, University of South Alabama Mobile Alabama 36604 —
Arizona Center for Cancer Care Glendale Arizona 85306 —
Southwest Cancer Care Medical Group Escondido California 92025 —
Marin Oncology Associates Greenbrae California 94904-2007 —
Wilshire Oncology Medical Group, Inc La Verne California 91750 —
North County Hematology Oncology (NCHO) - TRM, LLC. Oceanside California 92056 —
Hematology-Oncology Medical Group of Orange County, Inc. Orange California 92868 —
UC Davis Medical Center Sacramento California 95817 —
Central Coast Medical Oncology Corporation Santa Maria California 93454 —
Wellness Hematology Oncology West Hills California 92056 —
Cancer Center of Central Connecticut Southington Connecticut 06489 —
Florida Cancer Specialists North Region Sarah Cannon Research St. Petersburg Florida 33705 —
Illinois Cancer Care, P.C. Peoria Illinois 61615 —
LRG Healthcare Oncology Clinic Laconia Indiana 03246 —
Iowa Oncology Research Association Des Moines Iowa 50309 —
University of Louisville, J.G. Brown Cancer Center Louisville Kentucky 40202 —
Providence Cancer Institute Southfield Michigan 48075 —
Mayo Clinic Rochester Minnesota 55905 —
Coborn Cancer Center at the St. Cloud Hospital Saint Cloud Minnesota 56303 —
NH Oncology - Hematology, PA Hooksett New Hampshire 03106 —
The Cancer Center at Hackensack University Medical Center Hackensack New Jersey 07601 —
Hematology-Oncology Associates of Northern NJ Morristown New Jersey 07962 —
University of New Mexico Albuquerque New Mexico 87102 —
Weill Cornell Medical College New York New York 10065 —
SUNY Upstate Medical University Syracuse New York 13210 —
Wake Forest Baptist Health Winston-Salem North Carolina 27157 —
Oncology Hematology Care Sarah Cannon Research Cincinnati Ohio 45242 —
Local Institution - 028 Portland Oregon 97213 —
Providence Portland Medical Center Portland Oregon 97213 —
St Francis Hospital Greenville South Carolina 29607 —
Spartanburg Regional Healthcare System - Gibbs Cancer Center & Research Institute Spartanburg South Carolina 29303 —
Sarah Cannon Research Inst Nashville Tennessee 37203 —
Arlington Cancer Center Arlington Texas 76012 —
MD Anderson Cancer Center Houston Texas 77030 —
Northwest Medical Specialties PLLC Tacoma Washington 98405 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 125 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01938001, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 22, 2023 · Synced Oct 18, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01938001 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →