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

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

CpG 7909

About this trial

This is an interventional treatment trial for Chronic Lymphocytic Leukemia focused on measuring CpG 7909, CLL

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

University of Iowa
Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

CPG 7909 IV

CPG 7909 SQ

Arm Description

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

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.

Outcomes

Primary Outcome Measures

maximum tolerated dose

Secondary Outcome Measures

response

Full Information

NCT ID

NCT00233506

First Posted

October 3, 2005

Last Updated

February 2, 2017

Sponsor

University of Iowa

Collaborators

Mayo Clinic, Pfizer, National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00233506

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

July 2004 (undefined)

Primary Completion Date

June 2011 (Actual)

Study Completion Date

June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Iowa

Collaborators

Mayo Clinic, Pfizer, National Cancer Institute (NCI)

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Lymphocytic Leukemia

Keywords

CpG 7909, CLL

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

41 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CPG 7909 IV

Arm Type

Experimental

Arm Description

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

Arm Title

CPG 7909 SQ

Arm Type

Experimental

Arm 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.

Intervention Type

Drug

Intervention Name(s)

CpG 7909

Primary Outcome Measure Information:

Title

maximum tolerated dose

Time Frame

at study completion

Secondary Outcome Measure Information:

Title

response

Time Frame

at end of treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Brian Link, MD

Organizational Affiliation

UIHC

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Clive Zent, M.D.

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Iowa

City

Iowa City

State/Province

Iowa

ZIP/Postal Code

52242

Country

United States

Facility Name

Mayo Clinic

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Chronic Lymphocytic Leukemia

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial