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

• Sponsor: Genitope Corporation (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00302861
• Collaborator: (none)
• Enrollment: 86

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
B-Cell Chronic Lymphocytic Leukemia	Biological: MyVax	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Official Title: 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
• Study Start Date: Mar 1, 2006

Outcome Measures

Primary Outcome Measures

1. The proportion of patients with positive humoral immune responses []

2. Safety and toxicity []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Genitope Corporation

Investigators

• Principal Investigator: Thomas Kipps, M.D., University of California, San Diego

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00302861
• Other Study ID Numbers: 2005-11; NCT00313651
• First Posted: Mar 15, 2006
• Last Update Posted: Mar 18, 2008
• Last Verified: Mar 1, 2008

• Keywords provided by , ,: B-Cll
• Additional relevant MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell

Study Results

No Results Posted as of Mar 18, 2008