Lenalidomide and Rituximab in Treating Patients With Previously Untreated Stage II, Stage III, or Stage IV Follicular Non-Hodgkin Lymphoma
Part of paid clinical trials in Mountain View, California.
- Sponsor
- National Cancer Institute (NCI)
- Study ID
- NCT01145495
- Phase
- PHASE2
- Status
- Completed
Conditions
- Ann Arbor Stage II Grade 1 Contiguous Follicular Lymphoma
- Ann Arbor Stage II Grade 1 Non-Contiguous Follicular Lymphoma
- Ann Arbor Stage II Grade 2 Contiguous Follicular Lymphoma
- Ann Arbor Stage II Grade 2 Non-Contiguous Follicular Lymphoma
- Ann Arbor Stage II Grade 3 Contiguous Follicular Lymphoma
- Ann Arbor Stage II Grade 3 Non-Contiguous Follicular Lymphoma
- Ann Arbor Stage III Grade 1 Follicular Lymphoma
- Ann Arbor Stage III Grade 2 Follicular Lymphoma
- Ann Arbor Stage III Grade 3 Follicular Lymphoma
- Ann Arbor Stage IV Grade 1 Follicular Lymphoma
- Ann Arbor Stage IV Grade 2 Follicular Lymphoma
- Ann Arbor Stage IV Grade 3 Follicular Lymphoma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Laboratory Biomarker Analysis — OTHERCorrelative studies
- Lenalidomide — DRUGGiven PO
- Rituximab — BIOLOGICALGiven IV
Study Details
This phase II trial studies how well lenalidomide and rituximab work in treating patients with previously untreated stage II, stage III, or stage IV follicular non-Hodgkin lymphoma. Biological therapies, such as lenalidomide, may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Giving lenalidomide together with rituximab may kill more cancer cells.
Key Dates
- Start date
- Jun 15, 2010
- Status verified
- Jun 2023
- Primary completion
- Dec 31, 2012
- Completion
- Jan 15, 2022
Study Design
- Enrollment
- 66 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Treatment (lenalidomide, rituximab)Patients receive lenalidomide PO QD on days 1-21. Treatment with lenalidomide repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Patients also receive rituximab IV on days 1, 8, 15, and 22 and in weeks 13, 21, 29, and 37 in the absence of disease progression or unacceptable toxicity.
Primary Outcome Measure
Number of Participants Who Achieved a Complete Response [ Time Frame: At 12 months ]
Locations (91)
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By research site
Palo Alto Medical Foundation-Camino Division· Mountain View, CAPalo Alto Medical Foundation Health Care· Palo Alto, CABeebe Medical Center· Lewes, DEChristiana Care Health System-Christiana Hospital· Newark, DEMedStar Georgetown University Hospital· Washington D.C., DCAdventHealth Orlando· Orlando, FL