A Dose Finding Study of CpG in Patients With Chronic Lymphocytic Leukemia Who Have Been Previously Treated
Phase 1
Completed
- Conditions
- Chronic Lymphocytic Leukemia
- Interventions
- Drug: CpG 7909
- Registration Number
- NCT00233506
- Lead Sponsor
- University of Iowa
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 41
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CPG 7909 IV CpG 7909 Intravenous infusions will be administered with a standard infusion pump beginning at 125 cc/hr through an intravenous catheter (central or peripheral). CPG 7909 SQ CpG 7909 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.
- Primary Outcome Measures
Name Time Method maximum tolerated dose at study completion
- Secondary Outcome Measures
Name Time Method response at end of treatment
Trial Locations
- Locations (2)
University of Iowa
🇺🇸Iowa City, Iowa, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States