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

Genitope

Status and phase: Terminated; Phase 2; Phase 1

Conditions: B-Cell Chronic Lymphocytic Leukemia

Treatments: Biological: MyVax

Study type: Interventional

Funder types: Industry

Identifiers

NCT00302861

2005-11

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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