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A Dose Finding Study of CpG in Patients With Chronic Lymphocytic Leukemia Who Have Been Previously Treated
This study is currently recruiting participants.
Verified by University of Iowa, April 2007
Sponsors and Collaborators: University of Iowa
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

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Bio-availability Study
Official Title: A Dose-Finding Study of CpG 7909 in Previously Treated Chronic Lymphocytic Leukemia

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

Contacts
Contact: Mary E Shannon, RN 319-356-3516 mary-shannon@uiowa.edu

Locations
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Mary Shannon, RN     319-356-3516     mary-shannon@uiowa.edu    
Principal Investigator: James Wooldridge, MD            
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Connie Sylak, RN     507-284-8821        
Sub-Investigator: Clive Zent, M.D            
Sponsors and Collaborators
University of Iowa
Mayo Clinic
Pfizer
National Cancer Institute (NCI)
Investigators
Principal Investigator: James Wooldridge, MD UIHC
Principal Investigator: Clive Zent, M.D. Mayo Clinic
  More Information

Study ID Numbers: 200402002
Study First Received: October 3, 2005
Last Updated: April 18, 2007
ClinicalTrials.gov Identifier: NCT00233506  
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Iowa:
CpG 7909
CLL

Study placed in the following topic categories:
Chronic lymphocytic leukemia
Lymphatic Diseases
Signs and Symptoms
Leukemia
Leukemia, Lymphoid
 Immunoproliferative Disorders
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, B-cell, chronic
Lymphoproliferative Disorders
Leukemia, B-Cell

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009



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