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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00233506
First Posted: October 5, 2005
Last Update Posted: February 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Mayo Clinic
Pfizer
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Link, Brian K, University of Iowa
  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
Intervention Model: Single Group Assignment
Masking: None (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 Link, Brian K, University of Iowa:

Primary Outcome Measures:
  • maximum tolerated dose [ Time Frame: at study completion ]

Secondary Outcome Measures:
  • response [ Time Frame: at end of treatment ]

Enrollment: 41
Study Start Date: July 2004
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CPG 7909 IV
Intravenous infusions will be administered with a standard infusion pump beginning at 125 cc/hr through an intravenous catheter (central or peripheral).
Drug: CpG 7909
Experimental: CPG 7909 SQ
Subcutaneous injections should be administered in the abdominal wall, upper arm, hip, or anterior thigh. If the volume of injection exceeds 1.5 ml, the volume should be divided into equal injections at a volume less than 1.5 ml and administered in different areas of the body. The maximum dose level on this trial may require 5 - 6 injections at an equal number of sites.
Drug: CpG 7909

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Link, Brian K, Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT00233506     History of Changes
Other Study ID Numbers: 200402002
First Submitted: October 3, 2005
First Posted: October 5, 2005
Last Update Posted: February 6, 2017
Last Verified: February 2017

Keywords provided by Link, Brian K, University of Iowa:
CpG 7909
CLL

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