Randomized Phase II Study Of Interleukin-12 In Combination With Rituximab In Patients With Non-Hodgkin's Lymphoma
I. Compare the objective response in patients with B-cell non-Hodgkin's lymphoma treated
with rituximab and 2 different schedules of interleukin-12*.
II. Compare the toxic effects of these regimens in these patients. III. Determine the
objective response rate in patients with mantle cell lymphoma treated with these regimens.
IV. Determine the overall and progression-free survival of patients treated with these
V, Compare the quality of life of patients treated with these regimens. NOTE:
*Interleukin-12 will no longer be available after 6/30/05.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
histology (mantle cell lymphoma vs other [closed to accrual as of 3/10/04]) and
International Prognostic Factor Index (low and low-intermediate risk [closed to accrual as
of 3/10/04] vs high-intermediate and high risk). Patients are randomized to 1 of 2 treatment
ARM I: Patients receive rituximab IV on days 1, 8, 15, and 22. Patients receive
interleukin-12* subcutaneously (SC) twice weekly beginning on day 2 and continuing until
ARM II (closed to accrual as of 11/14/03): Patients receive rituximab as in arm I. Patients
are evaluated at week 12. Patients with stable or progressive disease receive
interleukin-12* SC twice weekly until disease progression or for 24 weeks. Patients with a
complete or partial response after rituximab are monitored until disease progression and
then begin interleukin-12 SC twice weekly until further disease progression.
NOTE: *Interleukin-12 will no longer be available after 06/30/05. Patients proceed to
follow-up as outlined below.
Quality of life is assessed at baseline and at 3 and 6 months.
Patients are followed every 3 months for 1 year and then every 6 months for up to 4 years.
PROJECTED ACCRUAL: A total of 90 patients (45 per treatment arm [arm II closed to accrual as
of 11/14/03]) will be accrued for this study within 3 years.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. In addition, confidence intervals for the response probability will be calculated according to the approach of Duffy and Santner.
North Central Cancer Treatment Group
United States: Food and Drug Administration
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