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A Dose Finding Study of CpG in Patients With Chronic Lymphocytic Leukemia Who Have Been Previously Treated
This study is ongoing, but not recruiting participants.

First Received on October 3, 2005.   Last Updated on June 14, 2010   History of Changes
Sponsor: University of Iowa
Collaborators: Mayo Clinic
Pfizer
National Cancer Institute (NCI)
Information provided by: University of Iowa
ClinicalTrials.gov Identifier: NCT00233506
  Purpose
  • CpG has the potential to stimulate the immune system
  • this study will evaluate the safety of CpG given sub-q or IV
  • purpose is to measure biological changes in CLL cells after receiving CpG

Condition Intervention Phase
Chronic Lymphocytic Leukemia
 Drug: CpG 7909
 Phase I

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Dose-Finding Study of CpG 7909 in Previously Treated Chronic Lymphocytic Leukemia

Resource links provided by NLM:

MedlinePlus related topics: Acute Lymphocytic Leukemia Chronic Lymphocytic Leukemia Leukemia
U.S. FDA Resources

Further study details as provided by University of Iowa:

Estimated Enrollment: 48
Study Start Date: July 2004
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of CLL
  • CLL previously treated
  • Hemoglobin >/= 10
  • Platelets >/= 50,000
  • Neutrophils >= 1,000 -

Exclusion Criteria:

  • patients with brain mets
  • patients with autoimmune disease
  • patients on corticosteroids or immunosuppressants
  • patients with uncontrolled intercurrent illness
  • pregnant women
  • HIV patients receiving combination anti-retroviral therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00233506

Locations
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
University of Iowa
Mayo Clinic
Pfizer
National Cancer Institute (NCI)
Investigators
Principal Investigator: Brian Link, MD UIHC
Principal Investigator: Clive Zent, M.D. Mayo Clinic
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00233506     History of Changes
Other Study ID Numbers: 200402002
Study First Received: October 3, 2005
Last Updated: June 14, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Iowa:
CpG 7909
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 February 09, 2012



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