NCT00695786

Lenalidomide in Combination With Rituximab in Treating Participants With Stage III/IV Indolent Non-Hodgkin Lymphoma

A Phase II Study of Revlimid in Combination With Rituximab as Initial Treatment for Patients With Indolent Non-Hodgkin's Lymphoma (NHL)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 156 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well lenalidomide works in combination with rituximab in treating participants with stage III-IV non-Hodgkin lymphoma that is growing slowly. Lenalidomide is designed to change the body's immune system. It may also interfere with the development of tiny blood vessels that help support tumor growth, which may prevent the growth of cancer cells. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Giving lenalidomide and rituximab may work better in participants with indolent non-Hodgkin lymphoma.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate the overall response rate of lenalidomide in combination with rituximab in previously untreated indolent non-Hodgkin's lymphoma (NHL). SECONDARY OBJECTIVES: I. To evaluate the toxicity of lenalidomide in combination with rituximab in previously untreated indolent non-Hodgkin's lymphoma. OUTLINE: Participants are assigned to 1 of 2 drug schedules. SCHEDULE A: Participants receive lenalidomide orally (PO) on days 1-21 and rituximab intravenously (IV) over 4-8 hours on day 1 of courses 1-12. Courses repeat every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. SCHEDULE B: Participants receive lenalidomide PO on days 2-22 and rituximab IV over 4-8 hours on days 1, 8, 15, and 22 of course 1 and on day 1 of all subsequent courses. Courses repeat every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, participants are followed up every 6 months.

Conditions

• Ann Arbor Stage III Grade 1 Follicular Lymphoma
• Ann Arbor Stage III Grade 2 Follicular Lymphoma
• Ann Arbor Stage III Indolent Adult Non-Hodgkin Lymphoma
• Ann Arbor Stage III Marginal Zone Lymphoma
• Ann Arbor Stage III Small Lymphocytic Lymphoma
• Ann Arbor Stage IV Grade 1 Follicular Lymphoma
• Ann Arbor Stage IV Grade 2 Follicular Lymphoma
• Ann Arbor Stage IV Indolent Adult Non-Hodgkin Lymphoma
• Ann Arbor Stage IV Marginal Zone Lymphoma
• Ann Arbor Stage IV Small Lymphocytic Lymphoma

Interventions

Type	Name	Description
DRUG	Lenalidomide	Given PO
BIOLOGICAL	Rituximab	Given IV

Timeline

• Start date: 2008-06-10
• Primary completion: 2020-07-11
• Completion: 2020-07-11
• First posted: 2008-06-12
• Last updated: 2021-10-20
• Results posted: 2021-09-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study