Phase II Study of Lenalidomide plus Rituximab in Patients with Previously Untreated Mantle Cell Lymphoma

Study Status

Open to Enrollment

Study Description

This is a phase II study of lenalidomide in combination with rituximab in patients with previously untreated mantle cell lymphoma, a type of non-Hodgkin’s lymphoma.

Significant progress has been made in treatment of mantle cell lymphoma, however, the majority of patients with MCL are not cured of their disease with the currently available chemotherapy-based options. The initial treatment for MCL is not standardized, and intensive chemotherapy does not seem to provide substantial benefit compared to conservative management in terms of long-term survival and quality-of-life measures. 

Recently, researchers have discovered that the tumor microenvironment--the normal cells and blood vessels that surround a tumor--can contribute to tumor growth by providing blood supply and creating a permissive environment. Biological compounds that disrupt the interaction and dependence of tumor cells with their microenvironment have shown promise in lymphoma therapy, including mantle cell lymphoma.

The purpose of this research study is to test the synergy of combining lenalidomide, a biological agent which targets the tumor microenvironment, and rituximab, an antibody that targets lymphoma cells. In addition to an induction phase, this study also incorporates a maintenance phase of lenalidomide and rituximab therapy. In this way, we hope to improve treatment effectiveness and maintain quality of life for patients.  

This study has two phases:

Induction Phase, Weeks 1-48:

  •  Treatment dose lenalidomide on days 1-21 of a 28-day cycle for 12 cycles
  •  Rituximab for a total of 9 doses

Maintenance Phase, Week 49 until disease progression or for a maximum of 5 years from study entry:

  • Maintenance dose lenalidominde on days 1-21 of a 28-day cycle

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Disease Status and/or Stage

Untreated Mantle Cell Lymphoma


Weill Cornell Medical College

Key Eligibility

  • Men and women ≥ age 18
  • Mantle Cell Non-Hodgkin Lymphoma
  • No prior systemic therapy for lymphoma including chemotherapy or immunotherapy; patients may have received involved-filed radiation therapy
  • Low-and-intermediate-risk disease or those not appropriate for chemotherapy
  • Detailed eligibility discussed when you contact the study team

Principal Investigator

Jia Ruan, MD


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Contact Us

For general inquiries, or if you need assistance finding a study, please contact:

Robert Hagerty
Subject Recruitment Manager
Tel: (646) 962-9340
[email protected]

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