A Dose Finding Study of CpG in Patients With Chronic Lymphocytic Leukemia Who Have Been Previously Treated

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by University of Iowa.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Mayo Clinic
Pfizer
Information provided by:
University of Iowa
ClinicalTrials.gov Identifier:
NCT00233506
First received: October 3, 2005
Last updated: June 14, 2010
Last verified: June 2010
  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 1

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:


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

ClinicalTrials.gov processed this record on October 21, 2014