This phase I/II trial studies the side effects and best dose of lenalidomide when given together with rituximab and combination chemotherapy and to see how well it works in treating patients with newly diagnosed stage II-IV diffuse large cell lymphoma or grade 3 follicular grade B-cell lymphoma. Lenalidomide may help the immune system kill abnormal blood cells or cancer cells and may also prevent the growth of new blood vessels that tumors need to grow. Monoclonal antibodies, such as rituximab, bind to a protein on the surface of cancer cells and activate the immune system to kill the cells. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving lenalidomide together with rituximab and combination chemotherapy may kill more cancer cells.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT00670358.
PRIMARY OBJECTIVES:
I. To assess the safety and efficacy of lenalidomide in combination with standard induction therapy (rituximab, cyclophosphamide, doxorubicin [doxorubicin hydrochloride], vincristine [vincristine sulfate] and prednisone - [RCHOP]) in patients with newly diagnosed diffuse large cell and follicular grade IIIA/B B-cell lymphoma.
II. To establish the maximum tolerated dose of lenalidomide in combination with RCHOP chemotherapy. (Phase I)
III. To assess the efficacy (event-free survival and response rate) and safety of this combination. (Phase II)
SECONDARY OBJECTIVES:
I. To assess the host immune function at baseline and after treatment and how these parameters relate to tumor response and event-free survival.
II. To assess the efficacy of this combination in diffuse large B-cell lymphoma (DLBCL) patients with activated B-cell-like lymphoma.
III. To assess the safety and efficacy of lenalidomide, rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (R2CHOP) in patients with transformed or composite follicular lymphoma.
OUTLINE: This is a phase I dose-escalation study of lenalidomide followed by a phase II study.
Patients receive rituximab intravenously (IV), cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 1; prednisone orally (PO) on days 1-5; and lenalidomide PO on days 1-10. Patients also receive pegfilgrastim subcutaneously (SC) on day 2. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for year 1, every 4 months for year 2, and then every 6 months for 3 years.
Lead OrganizationMayo Clinic in Rochester
Principal InvestigatorGrzegorz S. Nowakowski
