NCT01316523

Lenalidomide and Rituximab in Subjects With Previously Untreated Indolent Non-Hodgkin's Lymphoma

Phase II Study of Lenalidomide and Rituximab in Subjects With Previously Untreated Indolent Non Hodgkin's Lymphoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of California, Davis · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Lenalidomide has been shown to have single agent activity in indolent Non-Hodgkin's Lymphoma. It is approved for the treatment of multiple myeloma and myelodysplastic syndrome. Rituximab is effective as a single agent and in combination with chemotherapy for indolent Non-Hodgkin's Lymphoma. The purpose of this study is to see how well giving lenalidomide together with rituximab works in treating patients with previously untreated indolent Non Hodgkin's Lymphoma. Lenalidomide will taken at 20 mg daily, days 1-21 of a 28 day cycle, to be continued until the disease progresses, unacceptable side effects or after twelve cycles if the patient is responding well. Rituximab 375 mg/m2/wk x 4 weeks will begin on Day 15 of cycle 1. After 4 cycles of therapy, if patients respond well to treatment, patients will receive a second course of Rituximab. Blood samples will be collected to assess how the immune system is functioning.

Conditions

• Non Hodgkin's Lymphoma

Interventions

Type	Name	Description
DRUG	Rituximab	Rituximab 375 mg/m2/wk x 4 weeks, to begin Day 15 of cycle 1. After 4 cycles of therapy if patient does not respond to treatment, the patient will receive a second course of Rituximab.
DRUG	Lenalidomide	Lenalidomide will be taken at 20 mg daily, days 1-21 of a 28 day cycle, to be continued until the disease progresses, there are too many side effects, or after twelve cycles if the patient responds to treatment.

Timeline

• Start date: 2010-12-01
• Primary completion: 2023-09-12
• Completion: 2024-04-14
• First posted: 2011-03-16
• Last updated: 2025-11-21
• Results posted: 2025-11-21

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study