Lenalidomide and Rituximab in Treating Patients With Previously Untreated Stage II, Stage III, or Stage IV Follicular Non-Hodgkin Lymphoma
|Stage II Grade 1 Contiguous Follicular Lymphoma Stage II Grade 1 Non-Contiguous Follicular Lymphoma Stage II Grade 2 Contiguous Follicular Lymphoma Stage II Grade 2 Non-Contiguous Follicular Lymphoma Stage II Grade 3 Contiguous Follicular Lymphoma Stage II Grade 3 Non-Contiguous Follicular Lymphoma Stage III Grade 1 Follicular Lymphoma Stage III Grade 2 Follicular Lymphoma Stage III Grade 3 Follicular Lymphoma Stage IV Grade 1 Follicular Lymphoma Stage IV Grade 2 Follicular Lymphoma Stage IV Grade 3 Follicular Lymphoma||Other: Laboratory Biomarker Analysis Drug: Lenalidomide Biological: Rituximab||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of Lenalidomide (Revlimid (TM), CC-5013) (NSC #703813) Plus Rituximab in Previously Untreated Follicular Non-Hodgkin Lymphoma (NHL)|
- Number of Participants Who Achieved a Complete Response [ Time Frame: At 12 months ]Response is assessed by investigator according to International Working Group (IWG) criteria. Complete response requires disappearance of all evidence of disease.
- Toxicity of Study Treatment, Assessed by the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 [ Time Frame: Up to 10 years ]Data will be summarized using frequency tables.
- Time to Disease Progression [ Time Frame: Up to 10 years ]Kaplan-Meier method will be used.
- Time to Best Response [ Time Frame: Up to 10 years ]Kaplan-Meier method will be used.
|Actual Study Start Date:||June 15, 2010|
|Primary Completion Date:||December 31, 2012 (Final data collection date for primary outcome measure)|
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.
Other: Laboratory Biomarker Analysis
Correlative studiesDrug: Lenalidomide
Other Names:Biological: Rituximab
I. To determine the response rate (overall and complete) to lenalidomide + rituximab in follicular non-Hodgkin lymphoma (NHL) patients who have received no prior systemic therapy.
II. To determine the time to progression after lenalidomide + rituximab in previously untreated patients with cluster of differentiation (CD)20+ follicular NHL.
I. To determine the toxicity profile of lenalidomide + rituximab therapy in previously untreated patients with CD20+ follicular NHL.
II. To establish whether the therapeutic effects of lenalidomide + rituximab combination are sufficiently promising to warrant evaluation in a subsequent randomized trial (in comparison to rituximab alone).
III. To correlate fragment crystallizable gamma (Fcg) receptor polymorphism profiling with response to lenalidomide + rituximab in previously untreated patients with follicular NHL.
IV. To determine the impact of lenalidomide on immune parameters in patients with previously untreated follicular lymphoma.
V. To determine the impact of lenalidomide on angiogenic parameters in patients with previously untreated follicular lymphoma.
VI. To correlate lymphoma-associated macrophages (LAM) and forkhead box P3 (FOXP3), granzyme B (GzB), CD10, multiple myeloma oncogene 1 (MUM1), and B-cell lymphoma 2 (BCL2) expression with response to rituximab + lenalidomide in previously untreated patients with follicular lymphoma.
VII. Determine whether immune gene signatures previously identified as prognostic factors in follicular lymphoma (FL) can be applied to paraffin-embedded tissues in rituximab treated patients; evaluate micro ribonucleic acid (RNA) signatures associated with these gene signatures and outcome; to validate immunohistochemical markers associated with outcome in FL (CD68 LAMs, FOXP3, CD10, BCL6, FOXP1, MUM1); and investigate whether markers of angiogenesis may be of value in prognosis of FL.
Patients receive lenalidomide orally (PO) once daily (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 intravenously (IV) on days 1, 8, 15, and 22 and on weeks 13, 21, 29, and 37 in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 4 months for 2 years and then every 6 months for up to 8 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01145495
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|Principal Investigator:||Peter Martin||Alliance for Clinical Trials in Oncology|