A Study to Evaluate the Treatment of Previously Untreated B-Cell Chronic Lymphocytic Leukemia (B-CLL)

Phase 1/2 Study to Evaluate the Feasibility and Tolerability of Treatment of Previously Untreated B-CLL Chronic Lymphocytic Leukemia (B-CLL) Patients With Recombinant Idiotype Conjugated to KLH (Id-KLH) Administered With GM-CSF

This is a multi-center, open-label, single arm Phase 1/2 study evaluating the feasibility, safety, and tolerability of a series of 16 immunizations of Id-KLH with GM-CSF in patients with previously untreated B-CLL. The length of the controlled portion of the study is two years. The study will be conducted at investigative sites in the United States.

Inclusion Criteria:

• Have signed a written informed consent
• B-CLL diagnosis
• Rai Stage 0, I, or II
• Previously untreated
• Be able to watch and wait for approximately 8 months following submission of blood (or tissue) while Id-KLH is being manufactured

Exclusion Criteria:

• Anti-leukemia treatment prior to beginning immunization
• Anti-leukemia treatment other than Id-KLH during immunizations
• Prior malignancy (excluding basal cell carcinoma and cervical carcinoma in situ)
• Pregnant or lactating
• Patients with known autoimmune disease (including previously treated autoimmune hemolytic anemia or immune thrombocytopenia)
• Participation in any other clinical trial in which an investigational agent is administered