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Trial record 1 of 1 for:    MyVax
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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.
 
ClinicalTrials.gov Identifier: NCT00302861
Recruitment Status : Terminated
First Posted : March 15, 2006
Last Update Posted : March 18, 2008
Sponsor:
Information provided by:
Genitope Corporation

Tracking Information
First Submitted Date  ICMJE March 13, 2006
First Posted Date  ICMJE March 15, 2006
Last Update Posted Date March 18, 2008
Study Start Date  ICMJE March 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: February 14, 2007)
  • The proportion of patients with positive humoral immune responses
  • Safety and toxicity
Original Primary Outcome Measures  ICMJE
 (submitted: March 13, 2006)
  • The proortion of patients with positive humoral immune responses.
  • Safety and toxicity
Change History Complete list of historical versions of study NCT00302861 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Treatment of Previously Untreated B-Cell Chronic Lymphocytic Leukemia (B-CLL)
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Not Provided
Condition  ICMJE B-Cell Chronic Lymphocytic Leukemia
Intervention  ICMJE Biological: MyVax
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Enrollment  ICMJE
 (submitted: February 14, 2007)
86
Original Enrollment  ICMJE
 (submitted: March 13, 2006)
40
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Not Provided
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00302861
Other Study ID Numbers  ICMJE 2005-11
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Genitope Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Thomas Kipps, M.D. University of California, San Diego
PRS Account Genitope Corporation
Verification Date March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP