A Phase III Randomized Trial of CHOP Chemotherapy Plus Rituxan (IDEC-C2B8) Versus CHOP Chemotherapy Alone for Newly Diagnosed, Previously Untreated, Aggressive Non-Hodgkin's Lymphoma
OBJECTIVES: I. Determine whether the addition of rituximab to cyclophosphamide, doxorubicin,
vincristine, and prednisone (CHOP) increases the failure-free survival of patients with
newly diagnosed, previously untreated, aggressive B-cell non-Hodgkin's lymphoma. II.
Determine whether the addition of rituximab changes the toxicity profile attributed to CHOP
chemotherapy in this patient population.
OUTLINE: This is a randomized, multicenter study. Patients are stratified by center,
histology (diffuse small cleaved cell, diffuse mixed, and diffuse large cell vs
immunoblastic large cell, mantle cell, and marginal zone), and risk group (low vs
intermediate vs high). Patients enter one of two treatment arms: Arm I: Patients receive
rituximab IV on day 1, followed by cyclophosphamide IV, doxorubicin IV, vincristine IV, and
oral prednisone for 5 consecutive days beginning on day 3. Arm II: Patients receive
cyclophosphamide IV, doxorubicin IV, vincristine IV, and oral prednisone daily for 5
consecutive days beginning on day 1. Treatment repeats every 21 days for up to 6 courses in
the absence of disease progression or unacceptable toxicity. Patients will be followed for 3
PROJECTED ACCRUAL: A total of 270 patients (135 per treatment arm) will be accrued for this
study within 3 years.
Allocation: Randomized, Primary Purpose: Treatment
Julie M. Vose, MD
University of Nebraska
United States: Federal Government
|Jonsson Comprehensive Cancer Center, UCLA||Los Angeles, California 90095-1781|
|University of Nebraska Medical Center||Omaha, Nebraska 68198-3330|