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Completed

NCT Number: NCT00233506

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

* 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

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Key information

Conditions

Chronic Lymphocytic Leukemia Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Iowa, Iowa City, Iowa, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CPG 7909

Drug

Primary outcomes

  1. maximum tolerated dose

    Time frame: at study completion

Secondary outcomes

  1. response

    Time frame: at end of treatment

Sponsors and collaborators

Lead sponsor

University of Iowa

Other

Collaborators

  • Mayo Clinic
  • National Cancer Institute (NCI)
  • Pfizer

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2011
Study completion
2011
First posted
Oct 5, 2005
Registry last updated
Feb 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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