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

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2011-06-30

Brief Summary

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* 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

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Conditions

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Chronic Lymphocytic Leukemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

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).

Group Type EXPERIMENTAL

CpG 7909

Intervention Type DRUG

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.

Group Type EXPERIMENTAL

CpG 7909

Intervention Type DRUG

Interventions

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CpG 7909

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role collaborator

Pfizer

INDUSTRY

Sponsor Role collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Iowa

OTHER

Sponsor Role lead

Responsible Party

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Link, Brian K

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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200402002

Identifier Type: -

Identifier Source: org_study_id

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