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

Genitope Corporation0 sites86 target enrollmentMarch 2006

ConditionsB-Cell Chronic Lymphocytic Leukemia

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: B-Cell Chronic Lymphocytic Leukemia
Sponsor: Genitope Corporation
Enrollment: 86
Primary Endpoint: The proportion of patients with positive humoral immune responses
Status: Terminated
Last Updated: 18 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 2006

End Date

TBD

Last Updated

18 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Genitope Corporation

Eligibility Criteria

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