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

Phase 2TerminatedNCT00302861

Genitope Corporation86 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Enrollment

Conditions

B-Cell Chronic Lymphocytic Leukemia

Interventions

MyVaxBIOLOGICAL

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

The proportion of patients with positive humoral immune responses

Safety and toxicity

Data from ClinicalTrials.gov

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