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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell

ClinicalTrials.gov processed this record on September 18, 2014