OncRef

Clinical Trial: NCT01938001

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

Status:

COMPLETED

Phase:

Phase 3

Lead Sponsor:Celgene
Information Provided By:Celgene
Last Update Posted:2023-02-22

Study Overview

Brief 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.

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

Conditions

Lymphoma, Non-Hodgkin

Intervention / Treatment

  • Drug: Rituximab
  • Drug: Lenalidomide
  • Drug: Placebo

Other Study ID Numbers

  • CC-5013-NHL-007

Start Date (Actual)

2013-11-21

Primary Completion Date (Actual)

2018-06-22

Study Completion Date (Actual)

2022-01-26

Enrollment (Actual)

358

Study Type

Interventional

Phase

Phase 3