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NCT00233506 Clinical Trial

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

Chronic Lymphocytic Leukemia Clinical Trial

Official title:
A Dose-Finding Study of CpG 7909 in Previously Treated Chronic Lymphocytic Leukemia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00233506
Other study ID # 200402002
Secondary ID
Status Completed
Phase Phase 1
First received October 3, 2005
Last updated February 2, 2017
Start date July 2004
Est. completion date June 2011

Study information
Verified date February 2017
Source University of Iowa
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 41
Est. completion date June 2011
Est. primary completion date June 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• CpG 7909

Locations
Country Name City State
United States University of Iowa Iowa City Iowa
United States Mayo Clinic Rochester Minnesota

Sponsors (4)
Lead Sponsor Collaborator
University of Iowa Mayo Clinic, National Cancer Institute (NCI), Pfizer

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary maximum tolerated dose at study completion
Secondary response at end of treatment
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