FREE TREATMENT REPORT

See ratings and reviews when you sign up for an account.

High Dose Granulocyte Transfusions for the Treatment of Infection in Neutropenia: The RING Study (Resolving Infection in Neutropenia With Granulocytes)

This study is currently Recruiting

July 2011 By National Heart, Lung, and Blood Institute (NHLBI)

First Recieved on February 28, 2008

Last Updated on July 15, 2011

Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Collaborators:
Information provided by: National Heart, Lung, and Blood Institute (NHLBI)
Identifier: NCT00627393

Purpose

Neutropenia, a condition characterized by an abnormally low number of infection-fighting white blood cells called neutrophils, commonly develops in people who have undergone chemotherapy or hematopoietic stem cell (HSC) transplantation. The severely reduced immunity of those with neutropenia can put them at risk of entry of life-threatening infections, making the implementation of treatments that increase white blood cell numbers important. Several studies have shown that the transfusion of donor granulocytes, a type of white blood cell that includes neutrophils, is effective in promoting the recovery of adequate numbers of granulocytes. However, granulocyte transfusions can cause side effects, and it is not known whether the success of the therapy outweighs the health risks of the side effects. This study will evaluate the safety and effectiveness of granulocyte transfusions in treating people with a bacterial or fungal infection during neutropenia.

Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Eligibility

Ages Eligible for Study:N/A
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No
Criteria

Inclusion Criteria: - Severe neutropenia (Absolute Neutrophil Count < 500/mm^3) due to marrow failure caused by underlying disease or therapy - Must have one of the following: fungemia; bacteremia; proven or presumptive invasive tissue bacterial infection; or proven, probable, or presumptive invasive fungal infection Exclusion Criteria: - Unlikely to survive 5 days - Evidence that patient will not be neutropenic at least 5 days - Previously enrolled in this study

Investigators

  • Investigator: Susan F. Assmann, PhD - Principal Investigator - New England Research Institutes
  • Investigator: Jan McFarland, MD - Principal Investigator - Froedtert Memorial Lutheran Hospital
  • Investigator: Eliot Williams, MD - Principal Investigator - University of Wisconsin at Madison
  • Investigator: Ellis Neufeld, MD - Principal Investigator - Children's Hospital Boston/Brigham and Women's Hospital
  • Investigator: James Bussel, MD - Principal Investigator - Weill Medical College, Cornell University
  • Investigator: Cassandra Josephson, MD - Principal Investigator - Emory University
  • Investigator: Paul Ness, MD - Principal Investigator - Johns Hopkins University
  • Investigator: Sherrill Slichter, MD - Principal Investigator - University of Washington
  • Investigator: Thomas Price, MD - Study Chair - Puget Sound Blood Center
  • Investigator: Ronald Strauss, MD - Principal Investigator - University of Iowa
  • Investigator: Jeffrey McCullough, MD - Principal Investigator - University of Minnesota - Clinical and Translational Science Institute
  • Investigator: Nigel Key, MD - Principal Investigator - University of North Carolina, Chapel Hill
  • Investigator: James George, MD - Principal Investigator - University of Oklahoma
  • Investigator: Bruce Sachais, MD, PHD - Principal Investigator - University of Pennsylvania
  • Investigator: David Friedman, MD - Principal Investigator - Children's Hospital of Philadelphia
  • Investigator: Darrell Triulzi, MD - Principal Investigator - University of Pittsburgh Presbyterian and Shadyside/Children's Hospital Pittsburgh

Locations

  • Rocky Mountain Cancer Center

    Denver, Colorado 80218 United States

  • Bonfils Blood Center

    Denver, Colorado 80218 United States

  • University of Miami

    Miami, Florida 33136 United States

  • Childrens Hospital of Atlanta

    Atlanta, Georgia 30322 United States

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa 52242 United States

  • Johns Hopkins Hospital

    Baltimore, Maryland 21267 United States

  • Children's Hospital Boston

    Boston, Massachusetts 02115 United States

  • University of Minnesota

    Minneapolis, Minnesota 55455 United States

  • Montefiore Medical Center

    Bronx, New York 10461 United States

  • Weill Medical College, Cornell University

    New York, New York 10021 United States

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma 73104 United States

  • Oregon Health & Science University

    Portland, Oregon 97239 United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19104 United States

  • Chlidren's Hospital of Philadelphia

    Philadelphia, Pennsylvania 19104 United States

  • University of Pittsburgh Presbyterian and Shadyside

    Pittsburgh, Pennsylvania 15213 United States

  • University of Washington Medical Center

    Seattle, Washington 98195 United States

  • University of Wisconsin at Madison

    Madison, Wisconsin 53792 United States

  • Froedtert Memorial Lutheran Hospital

    Milwaukee, Wisconsin 53201 United States

  • Children's Hospital of Wisconsin

    Milwaukee, Wisconsin 53233 United States

Conditions related to this trial:

advertisement
V2012.311.925.327
Disclaimer: The list and ratings above are for informational purposes only, and is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. The goal of the information is to provide you with a comprehensive view of all available treatments, but should not be construed to indicate that use of any one treatment is safe, appropriate, or effective for you. Decisions about use of a new treatment, or about a change in your current treatment plan, should be in consultation with your doctor or other healthcare professional.