A Dose Finding Study of CpG in Patients With Chronic Lymphocytic Leukemia Who Have Been Previously Treated
A Dose-Finding Study of CpG 7909 in Previously Treated Chronic Lymphocytic Leukemia
1 other identifier
interventional
41
1 country
2
Brief Summary
- 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jul 2004
Longer than P75 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2004
CompletedFirst Submitted
Initial submission to the registry
October 3, 2005
CompletedFirst Posted
Study publicly available on registry
October 5, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedFebruary 6, 2017
February 1, 2017
6.9 years
October 3, 2005
February 2, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
maximum tolerated dose
at study completion
Secondary Outcomes (1)
response
at end of treatment
Study Arms (2)
CPG 7909 IV
EXPERIMENTALIntravenous infusions will be administered with a standard infusion pump beginning at 125 cc/hr through an intravenous catheter (central or peripheral).
CPG 7909 SQ
EXPERIMENTALSubcutaneous 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.
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of CLL
- CLL previously treated
- Hemoglobin \>/= 10
- Platelets \>/= 50,000
- Neutrophils \>= 1,000 -
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Iowalead
- Mayo Cliniccollaborator
- Pfizercollaborator
- National Cancer Institute (NCI)collaborator
Study Sites (2)
University of Iowa
Iowa City, Iowa, 52242, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Brian Link, MD
UIHC
- PRINCIPAL INVESTIGATOR
Clive Zent, M.D.
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 3, 2005
First Posted
October 5, 2005
Study Start
July 1, 2004
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
February 6, 2017
Record last verified: 2017-02