Phase III, Double-Blind, Randomized, Placebo-Controlled Trial of FavID® (Id/KLH) and GM-CSF Following CHOP/Rituximab as First-Line Therapy in Subjects With High-Intermediate and High-Risk Diffuse Large B-Cell Lymphoma

Trial Information

Phase III, Double-Blind, Randomized, Placebo-Controlled Trial of FavID® (Id/KLH) and GM-CSF Following CHOP/Rituximab as First-Line Therapy in Subjects With High-Intermediate and High-Risk Diffuse Large B-Cell Lymphoma

OBJECTIVES:

Primary

- Compare the 3-year disease-free survival of patients with high-intermediate- or
high-risk bulky stage II or stage III or IV diffuse large B-cell lymphoma treated with
sargramostim (GM-CSF) with or without autologous immunoglobulin idiotype-KLH conjugate
vaccine (FavId®) after combination chemotherapy comprising cyclophosphamide,
doxorubicin, vincristine, prednisone, and rituximab (CHOP-R).

Secondary

- Compare the 2-year disease-free survival, duration of response, time to progression,
overall survival, and safety in patients treated with these regimens.

- Estimate the rate of immune reactivity to FavId®.

OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are
stratified according to risk score (3 [high-intermediate] vs 4 or 5 [high]).

- Chemotherapy: Patients receive cyclophosphamide IV, doxorubicin hydrochloride IV,
vincristine IV, and rituximab IV on day 1 and oral prednisone on days 1-5. Treatment
repeats every 21 days for up to 8 courses in the absence of disease progression or
unacceptable toxicity.

- Sargramostim (GM-CSF) with or without autologous immunoglobulin idiotype-KLH conjugate
vaccine (FavId®): Patients achieving complete remission (CR) or unconfirmed CR after
chemotherapy and who have FavId® available are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive FavId® vaccine subcutaneously (SC) on day 1. Patients also
receive sargramostim (GM-CSF) SC on days 1-4.

- Arm II: Patients receive placebo SC on day 1 and GM-CSF SC as in arm I. In both
arms, treatment repeats once a month for 6 months and then once every 2 months for
24 months (18 total vaccinations) in the absence of disease progression or
unacceptable toxicity.

After completion of study treatment, patients are followed periodically for up to 2 years.

PROJECTED ACCRUAL: A total of 480 patients will be accrued for this study.