A Dose Finding Study of CpG in Patients With Chronic Lymphocytic Leukemia Who Have Been Previously Treated
NCT ID: NCT00233506
Last Updated: 2017-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
41 participants
INTERVENTIONAL
2004-07-31
2011-06-30
Brief Summary
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* 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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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).
CpG 7909
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.
CpG 7909
Interventions
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CpG 7909
Eligibility Criteria
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Inclusion Criteria
* CLL previously treated
* Hemoglobin \>/= 10
* Platelets \>/= 50,000
* Neutrophils \>= 1,000 -
Exclusion Criteria
* patients with autoimmune disease
* patients on corticosteroids or immunosuppressants
* patients with uncontrolled intercurrent illness
* pregnant women
* HIV patients receiving combination anti-retroviral therapy
18 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Pfizer
INDUSTRY
National Cancer Institute (NCI)
NIH
University of Iowa
OTHER
Responsible Party
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Link, Brian K
Professor
Principal Investigators
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Brian Link, MD
Role: PRINCIPAL_INVESTIGATOR
UIHC
Clive Zent, M.D.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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University of Iowa
Iowa City, Iowa, United States
Mayo Clinic
Rochester, Minnesota, United States
Countries
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Other Identifiers
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200402002
Identifier Type: -
Identifier Source: org_study_id
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