Genitope Protocol 2005-11

A 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

Status: Closed to patient registration.

Design: Study 2005-11 is a multi-center, open-label, single arm phase 1/2 study. It will evaluate the feasibility, safety and tolerability of a series of 16 immunizations of recombinant Id-KLH (rId-KLH) with GM-CSF in patients with previously untreated CLL.

Purpose: The treatment being investigated is rId-KLH, a patient- and tumor-specific therapy known as a 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 personalized immunotherapy because it may enhance the effect of the personalized immunotherapy.

This approach has previously been studied in patients with other B-cell malignancies. Encouraging efficacy results and a favorable safety profile have been seen to date in these studies. Since CLL is another type of B-cell malignancy, it is thought that personalized immunotherapy may be helpful in this patient population.

Primary Objectives:

  • Rate of humoral anti-Id and anti-KLH immune responses
  • Safety and tolerability

Secondary Objectives:

  • Total lymphocyte count over time
  • Clinical response
  • Time to subsequent anti-leukemia therapy

Selected Eligibility Criteria:

  1. Have signed a written informed consent
  2. CLL diagnosis
  3. Rai Stage 0, I or II
  4. Previously untreated
  5. Be able to watch and wait for approximately 8 months following submission of blood (or tissue) sample while Id-KLH is being manufactured
  6. ≥ 18 years of age

Treatment: Eligible patients will provide a blood sample or tissue sample from which their personalized immunotherapy will be made. Manufacture of Personalized Immunotherapy may take up to 8 months. Patients’ disease activity will be observed while their personalized immunotherapy is being made. “Watchful waiting” is the typical standard of care for patients who are eligible for this study. Once the personalized immunotherapy is produced, a series of 16 immunizations with Id-KLH plus GM-CSF will be given over a 1-year time period. The immunizations will be followed by a 1-year observation period during which study visits will occur every 3 months. After that, patients or their treating physicians will be contacted every 6 months to collect information about subsequent anti-leukemia therapy and survival.

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