Status:
TERMINATED
A Study to Evaluate the Treatment of Previously Untreated B-Cell Chronic Lymphocytic Leukemia (B-CLL)
Lead Sponsor:
Genitope Corporation
Conditions:
B-Cell Chronic Lymphocytic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 un...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT00302861
Start Date
March 1 2006
Last Update
March 18 2008
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