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
- 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
- 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
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.
Primary Purpose: Treatment
Toxicity as assessed by NCI CTCAE v3.0 (Phase I)
Grzegorz S. Nowakowski, M.D.
United States: Food and Drug Administration
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