Trial Information

Randomized Study Comparing 4 and 6 Cycles of Chemotherapy With CHOP (Cyclophosphamide, Doxorubicin, Vincristine and Prednisone) at 21-day Intervals, Both With 6 Cycles of Immunotherapy With the Monoclonal Anti-CD20-Positive B-Cell Lymphoma Aged 18-60 Years Having no Risk Factor (Age-Adjusted IPI=0) and No Large Tumor Mass (Diameter <7,5cm) [FLYER 6-6-6-4 Study]

OBJECTIVES:

Primary

- Compare the efficacy of 2 different schedules of immunochemotherapy comprising
rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone in
patients with previously untreated, low-risk, aggressive B-cell non-Hodgkin's lymphoma.

- Compare acute and chronic side effects in patients treated with these regimens.

- Compare time to treatment failure in patients treated with these regimens.

Secondary

- Compare the time to progression in patients treated with these regimens.

- Compare the overall and disease-free/relapse-free survival of patients treated with
these regimens.

- Compare the complete response rate in patients treated with these regimens.

- Compare the tumor control in patients treated with these regimens.

- Compare the safety of these regimens in these patients.

- Compare the pharmacoeconomics of these regimens.

- Compare patient adherence to these regimens.

OUTLINE: This is an open-label, randomized, multicenter study. Patients are stratified
according to participating center. Patients are randomized to 1 of 2 treatment arms.

All patients are given the option of receiving a 1-week course of pretreatment therapy
comprising vincristine IV once on day -6 and oral prednisone once daily on days -6 to 0.

- Arm I: Patients receive R-CHOP immunochemotherapy comprising rituximab IV,
cyclophosphamide IV over 15 minutes, doxorubicin hydrochloride IV, and vincristine IV
on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days
for 3 courses in the absence of disease progression or unacceptable toxicity. Patients
then undergo restaging of their disease. Patients with disease progression proceed to
salvage therapy off study. All other patients receive 3 more courses of R-CHOP.

- Arm II: Patients receive R-CHOP as in arm I. Treatment repeats every 21 days for 3
courses in the absence of disease progression or unacceptable toxicity. Patients then
undergo restaging of their disease. Patients with disease progression proceed to
salvage therapy off study. All other patients receive 1 more course of R-CHOP followed
by 2 courses of rituximab alone.

All patients undergo final restaging after 6 courses of rituximab. Patients with disease
progression, stable disease, or partial response proceed to salvage therapy off study.

After completion of study treatment, patients are followed periodically for 5 years and then
annually thereafter.

PROJECTED ACCRUAL: A total of 622 patients will be accrued for this study.