Trial Information

Phase II Trial of Maintenance Rituximab Plus FavId® and GM-CSF Immunotherapy in Patients With Treatment-Naive Indolent B-Cell Lymphoma

OBJECTIVES:

- Determine the efficacy of immunotherapy comprising rituximab, autologous immunoglobulin
idiotype-KLH conjugate vaccine (FavId™), and sargramostim (GM-CSF), in terms of
response rate (partial and complete) and event-free survival, in patients with indolent
B-cell non-Hodgkin's lymphoma.

- Determine the safety of this regimen in these patients.

- Evaluate development of an immune response in patients treated with this regimen.

OUTLINE: This is an open-label, multicenter study.

- Induction therapy: Patients receive rituximab IV over 2-4 hours once weekly for 4
weeks. Patients are evaluated for response at month 3. Patients with responding or
stable disease proceed to maintenance therapy. Patients with progressive disease are
removed from study.

- Maintenance therapy: Patients receive rituximab as in induction therapy in months 7,
13, and 19. Patients also receive autologous immunoglobulin idiotype-KLH conjugate
vaccine (FavId™) subcutaneously (SC) once on day 1 and sargramostim (GM-CSF) SC once
daily on days 1-4 in months 4-6, 8-11, 14, 16, 18, 20, 22, and 24. Patients with
continued response after completing 2 years of therapy may continue to receive FavId™
and GM-CSF once every 3 months in the absence of disease progression or unacceptable
toxicity.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 56 patients will be accrued for this study.