Genitope Protocol 2000-03

A Phase 3 Trial to Evaluate the Safety and Efficacy of the Specific Immunotherapy, Recombinant Idiotype Conjugated to KLH with GM-CSF, Compared to Non-Specific Immunotherapy, KLH with GM-CSF, in Patients with Follicular Non-Hodgkin's Lymphoma (Protocol: G2000-03)

Status: Closed to patient registration. Patients already registered to the study are being treated according to the protocol at more than 34 medical centers across the United States and Canada.

Design: Study 2000-03 is a multi-center, randomized, double-blind, Phase 3 study evaluating previously untreated patients with follicular NHL (stage III or IV). In this study, patients' tumor burden is reduced with chemotherapy (cyclophosphamide, vincristine, prednisone [CVP]). Patients who respond to eight cycles of CVP chemotherapy (at least a 50% reduction in tumor burden) and maintain the response through a subsequent 6 month rest period are randomized in a 2:1 fashion. In the 2:1 randomization scheme, patients receive series of seven immunizations over a 24 week period. Each immunization is administered at four-week intervals and consists of subcutaneous injections of Id-KLH and GM-CSF or KLH-KLH and GM-CSF. On day one of each immunization, patients receive the Id-KLH or KLH-KLH component, with the dose divided and administered at two separate injection sites, immediately followed by injection of GM-CSF (250 µg total dose divided equally between the two injection sites). Patients then receive GM-CSF (250 µg total dose divided equally between the two injection sites) on days two-four of each immunization.

Primary Objective

  1. To assess progression free survival (PFS) in patients with previously untreated follicular lymphoma treated with eight cycles of CVP chemotherapy followed by a series of 7 immunizations of patient-specific recombinant Id conjugated to KLH (Id-KLH) with GM-CSF, when compared to those treated with eight cycles of CVP chemotherapy followed by a series of 7 immunizations with KLH conjugated to KLH (KLH-KLH) with GM-CSF.
  2. To assess the safety and toxicity of 7 subcutaneous immunizations of Id-KLH administered with GM-CSF as compared to 7 subcutaneous immunizations of KLH-KLH with GM-CSF.

Sponsor: Genitope Corporation, 6900 Dumbarton Cr., Fremont, CA  94555-3651, 1-866-Genitop (1-866-436-4867).

For questions about Genitope Corporation's clinical trials, please complete and submit the Request Information Form, send email to clinicalinfo@genitope.com, or call our toll-free hotline at 1-866-GENITOP (1-866-436-4867).