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

This study has been terminated.
Sponsor:
Information provided by:
Genitope Corporation
ClinicalTrials.gov Identifier:
NCT00302861
First received: March 13, 2006
Last updated: March 14, 2008
Last verified: March 2008
History of Changes
  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 1
Phase 2

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

Resource links provided by NLM:

U.S. FDA Resources

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

No publications provided

ClinicalTrials.gov Identifier: NCT00302861     History of Changes
Obsolete Identifiers: NCT00313651
Other Study ID Numbers: 2005-11
Study First Received: March 13, 2006
Last Updated: March 14, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Genitope Corporation:
B-Cll
B-CLL

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
 Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on May 16, 2013