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

Phase 1

Terminated

• Conditions: B-Cell Chronic Lymphocytic Leukemia

• Registration Number: NCT00302861
• Lead Sponsor: Genitope Corporation

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2006-03-13
• Study First Submitted QC: 2006-03-13
• Study First Posted: 2006-03-15
• Status Verified: 2008-03
• Last Update Submitted: 2008-03-14
• Last Update Posted: 2008-03-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 86

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of patients with positive humoral immune responses
Safety and toxicity