Clinical Trials Information

Patient

A clinical trial is a research study to answer specific questions about new drugs or treatments for disease. Clinical trials are used to determine whether new treatments are both safe and effective in humans. These trials generally occur after extensive work in the laboratory and in animal studies. Regulated by the Food and Drug Administration (FDA) and other regulatory agencies around the world, carefully conducted clinical trials are an established way to find treatments that are safe and effective.

Genitope's lead product candidate, MyVax® Personalized Immunotherapy (previously referred to as GTOP-99), is an investigational treatment based on the unique genetic makeup of a patient's tumor and is designed to activate a patient's immune system to identify and attack cancer cells. This product is currently being evaluated in a pivotal Phase 3 trial in patients with follicular non-Hodgkin's lymphoma (f-NHL). Genitope has completed the patient registration phase of this study; the treatment and follow-up phases of the study are ongoing. MyVax® Personalized Immunotherapy is also being studied in an ongoing Phase 2 rollover study for patients who have entered the Phase 3 study but who fail to achieve at least a partial response after eight cycles of CVP chemotherapy or who progress during the subsequent 6 month rest period. In this study, MyVax® Personalized Immunotherapy is being tested in conjunction with the anti-CD20 antibody, Rituxan® (rituximab). Several additional Phase 2 trials in patients with B-cell non-Hodgkin's lymphoma are closed to enrollment and are in long-term follow-up. Also, MyVax® Personalized Immunotherapy is being tested in a Phase 1/2 study evaluating previously untreated patients with CLL Rai stage 0, I, and II. For further information on Genitope's clinical trial program, please browse the information in this section of our website.

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MyVax® Personalized Immunotherapy Trials Closed to Patient Registration

  • Genitope Protocol 2007-12: 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).
  • Genitope Protocol 2005-11: Phase 1/2 Study to Evaluate the Feasibility and Tolerability of Treatment of Previously Untreated B-Cell Chronic Lymphocytic Leukemia (B-CLL) Patients with Recombinant Idiotype Conjugated to KLH (Id-KLH) Administered with GM-CSF.
  • Genitope Protocol 2000-03: 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
  • Genitope Protocol 2002-09: Phase 2 Study to Evaluate Safety and Efficacy of Speicif Immunotherapy, Recombinant Idiotype Conjugated to KLH (MyVax® Personalized Immunotherapy), and GM-CSF Following the Anti-CD20 Antibody, Rituxan®, in Previously Treated Patients with Follicular Non-Hodgkin’s Lymphoma. Note: this trial is only available to patients previously enrolled in Genitope Protocol 2000-03.
  • Genitope Protocol 9901: Phase 2 Trial to Evaluate the Rate of Immune Response Using Idiotype Immunotherapies Produced by Molecular Biologic Means for Treatment of Indolent B-Cell Lymphoma
  • Genitope Protocol 9902: Phase 2 Trial to Evaluate the Rate of Immune Response Using Idiotype Immunotherapies Produced by Molecular Biologic Means for Treatment of Aggressive B-Cell Lymphoma
  • Genitope Protocol 2000-04: Phase 2 Trial to Evaluate the Efficacy of Recombinant Idiotype Immunotherapies for Patients with Follicular B-Cell Lymphoma in "Watch and Wait" Period
  • Genitope Protocol 2000-07: Genitope Protocol 2000-07: A Phase 2 Trial to Evaluate the Efficacy of Recombinant Idiotype with Abbreviated Course of GM-CSF Adjuvant in Follicular B-Cell Lymphoma

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).