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

NCT01938001 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 358

Last updated 2023-02-22

Study results available
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Summary

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.

Conditions

  • Lymphoma, Non-Hodgkin

Interventions

DRUG

Rituximab

Rituximab 375mg/m\^2 IV every week in Cycle 1 (Days 1, 8, 15 and 22) on Day 1 of every 28 day cycle from Cycles 2 to 5

DRUG

Lenalidomide

Lenalidomide 20mg by mouth (PO) daily on Days 1 to 21 every 28 days up to 12 cycles

DRUG

Placebo

Placebo (identical matched capsule) PO daily on Days 1 to 21 every 28 days

Sponsors & Collaborators

  • Celgene

    lead INDUSTRY

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-21
Primary Completion
2018-06-22
Completion
2022-01-26

Countries

  • United States
  • Belgium
  • Brazil
  • China
  • Czechia
  • France
  • Germany
  • Israel
  • Italy
  • Japan
  • Poland
  • Portugal
  • Puerto Rico
  • Russia
  • Spain
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01938001 on ClinicalTrials.gov