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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00302861
Recruitment Status : Terminated
First Posted : March 15, 2006
Last Update Posted : March 18, 2008
Information provided by:
Genitope Corporation

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

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Study Type : Interventional  (Clinical Trial)
Enrollment : 86 participants
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 : March 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. The proportion of patients with positive humoral immune responses
  2. Safety and toxicity

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00302861

Sponsors and Collaborators
Genitope Corporation
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Principal Investigator: Thomas Kipps, M.D. University of California, San Diego
Layout table for additonal information Identifier: NCT00302861    
Obsolete Identifiers: NCT00313651
Other Study ID Numbers: 2005-11
First Posted: March 15, 2006    Key Record Dates
Last Update Posted: March 18, 2008
Last Verified: March 2008
Keywords provided by Genitope Corporation:
Additional relevant MeSH terms:
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Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell