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

University of Iowa

Status and phase: Completed; Phase 1

Conditions: Chronic Lymphocytic Leukemia

Treatments: Drug: CpG 7909

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT00233506

200402002

Details and patient eligibility

About

• 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

Enrollment: 41 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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41 participants in 2 patient groups

CPG 7909 IV

Experimental group

Description:

Intravenous infusions will be administered with a standard infusion pump beginning at 125 cc/hr through an intravenous catheter (central or peripheral).

Treatment:

Drug: CpG 7909

CPG 7909 SQ

Experimental group

Description:

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.

Treatment:

Drug: CpG 7909