Lenalidomide, Rituximab, and Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II, Stage III, or Stage IV Diffuse Large Cell or Follicular B-Cell Lymphoma
RATIONALE: Lenalidomide may stimulate the immune system in different ways and stop cancer cells from growing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide together with rituximab and combination chemotherapy may kill more cancer cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of lenalidomide when given together with rituximab and combination chemotherapy and to see how well they work in treating patients with newly diagnosed stage II, stage III, or stage IV diffuse large cell or follicular B-cell lymphoma.
|Lymphoma||Biological: pegfilgrastim Biological: rituximab Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: lenalidomide Drug: prednisone Drug: vincristine sulfate Genetic: polymorphism analysis Other: laboratory biomarker analysis||Phase 1 Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I/II Study of Lenalidomide (Revlimid), Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone (R2CHOP) Chemoimmunotherapy in Patients With Newly Diagnosed Diffuse Large Cell and Follicular Grade IIIA/B B Cell Lymphoma|
- Toxicity as assessed by NCI CTCAE v3.0 (Phase I)
- Event-free survival at 12 months (Phase II)
- Overall response rate
- Overall complete response rate
- Event-free survival
- Overall survival
- Progression-free survival
- Duration of response
- Immune function before and after treatment as assessed by T-, B-, and NK-cell quantification
- Correlation of immune function with clinical outcomes
|Study Start Date:||August 2008|
|Estimated Primary Completion Date:||May 2017 (Final data collection date for primary outcome measure)|
- To determine the maximum tolerated dose of lenalidomide when given in combination with rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone in patients with newly diagnosed stage II-IV diffuse large cell or grade 3 follicular B-cell lymphoma. (Phase I)
- To assess the efficacy of this regimen, in terms of event-free survival and response rate, in these patients. (Phase II)
- To assess the safety of this regimen in these patients. (Phase II)
- To assess the host immune function at baseline and after treatment and correlate these parameters with tumor response and event-free survival.
OUTLINE: This is a multicenter, phase I dose-escalation study of lenalidomide followed by a phase II study.
- Phase I: Patients receive rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine IV on day 1, oral prednisone on days 1-5, and oral lenalidomide on days 1-10. Patients also receive pegfilgrastim subcutaneously on day 2. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
- Phase II: Patients receive lenalidomide at the maximum tolerated dose determined in phase I and rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, prednisone, and pegfilgrastim as in phase I.
Blood is collected at baseline, before course 3, and after completion of study treatment for translational research studies. Research studies include immune function and cytokine analysis, T- and B- quantitative lymphocyte analysis, and single nucleotide polymorphism analysis.
After completion of study therapy, patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 3 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00670358
|United States, Arizona|
|Mayo Clinic in Arizona||Active, not recruiting|
|Scottsdale, Arizona, United States, 85259-5499|
|United States, Florida|
|Mayo Clinic in Florida||Active, not recruiting|
|Jacksonville, Florida, United States, 32224|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Contact: Clinical Trials Referral Office 855-776-0015|
|Principal Investigator: Grzegorz S. Nowakowski, M.D.|
|Study Chair:||Grzegorz S. Nowakowski, M.D.||Mayo Clinic|
|Principal Investigator:||Craig B. Reeder, M.D.||Mayo Clinic|
|Principal Investigator:||Candido E. Rivera, M.D.||Mayo Clinic|
|Study Chair:||Judy Olmos, R.N.||Mayo Clinic|
|Study Chair:||Michele Maharaj, R.N.||Mayo Clinic|