Protocol 2007-12

Genitope Protocol 2007-12

A Phase 2 Multi-Center, Open-Label Study to Evaluate the Efficacy and Safety of Patient-Specific Immunotherapy, Recombinant Idiotype Conjugated to KLH (Id-KLH) and Administered with GM-CSF, in Patients with Follicular Non-Hodgkin’s Lymphoma (fNHL) Following Primary Treatment with Rituximab and Chemotherapy (R-Chemo)

Status: Open to patient registration.

Design: Study 2007-12 is a multi-center, open-label, phase 2 study evaluating the safety and efficacy of a series of 24 immunizations of Id-KLH (Id-KLH) with GM-CSF in patients with previously untreated fNHL following primary treatment with rituximab and chemotherapy (R-Chemo).

Purpose: The treatment being investigated is Id-KLH, a patient- and tumor-specific therapy known as personalized immunotherapy.  Personalized immunotherapy uses a person’s own immune system in an attempt to combat disease.  Sargramostim (a.k.a. GM-CSF) is given together with the Id‑KLH therapy because it may enhance the effect of the personalized immunotherapy. In this study, the personalized immunotherapy will be given after standard of care treatment rituximab and chemotherapy for initial treatment with lymphoma.

This approach has previously been studied in patients with fNHL and other B-cell malignancies.  Encouraging efficacy findings and a favorable safety profile have been seen to date in these studies.  It is thought that personalized immunotherapy may have a role in the treatment of patients with fNHL.

Primary Objectives:

·        Rate of humoral anti-Id and anti-KLH immune response development

·        Safety and tolerability

Secondary Objectives:

·        Progression free survival

·        Clinical response status

·        Time to receipt of subsequent anti-lymphoma therapy

Selected Eligibility Criteria:

  1. Written informed consent
  2. Previously untreated fNHL
  3. Stage III or IV disease requiring treatment


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