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

This study has been terminated.

Sponsored by:	Genitope Corporation
Information provided by:	Genitope Corporation
ClinicalTrials.gov Identifier:	NCT00302861

Purpose

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	Intervention	Phase
B-Cell Chronic Lymphocytic Leukemia	Biological: MyVax	Phase I Phase II

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for: Sargramostim Granulocyte-macrophage colony-stimulating factor

U.S. FDA Resources

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

Further study details as provided by Genitope Corporation:

Primary Outcome Measures:

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

Estimated Enrollment:	86
Study Start Date:	March 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00302861

Sponsors and Collaborators

Genitope Corporation

Investigators

Principal Investigator:

Thomas Kipps, M.D.

University of California, San Diego

More Information

Study ID Numbers:	2005-11
Study First Received:	March 13, 2006
Last Updated:	March 14, 2008
ClinicalTrials.gov Identifier:	NCT00302861
Health Authority:	United States: Food and Drug Administration

Keywords provided by Genitope Corporation:

B-Cll
B-CLL

Study placed in the following topic categories:

Chronic lymphocytic leukemia
Lymphatic Diseases
Leukemia
Leukemia, Lymphoid
Immunoproliferative Disorders

Immunoglobulin Idiotypes
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, B-cell, chronic
Lymphoproliferative Disorders
Leukemia, B-Cell

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009