Safety and Effectiveness of Granulocyte Transfusions in Resolving Infection in People With Neutropenia (The RING Study)

Summary

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.

Conditions

• Neutropenia
• Infection

Interventions

DRUG

Standard antimicrobial therapy

Antimicrobial therapy is broadly defined as therapy within the standard of care for a particular infection and should be consistent within a given institution. Participants will undergo the recommended therapy for specific infections for 42 days.

BIOLOGICAL

Granulocyte transfusions

Participants will receive one granulocyte transfusion per day until one of the following occurs: recovery from neutropenia, life-threatening toxicity, resolution or improvement of infection, or Day 42 after treatment. Granulocyte content of each transfusion is targeted to be at least 4 x 10\^10 per collection (or proportionately less for participants less than 30 kg in weight).

DRUG

G-CSF/dexamethasone

Twelve hours before each donation, participants will be injected with G-CSF and will take one dose of dexamethasone by mouth.

DEVICE

Apheresis machine

Participants will undergo a procedure using an apheresis machine for granulocyte collection. The procedure will last 3 to 4 hours and will involve the drawing of blood from each arm, the separation of granulocytes from the red cells and plasma in the machine, and the return of the red cells and plasma to the participants.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• Carelon Research

  lead OTHER

Principal Investigators

• Susan F. Assmann, PhD · Carelon Research

• Jan McFarland, MD · Froedtert Hospital

• Eliot Williams, MD · University of Wisconsin, Madison

• Ellis Neufeld, MD · Children's Hospital Boston/Brigham and Women's Hospital

• James Bussel, MD · Weill Medical College, Cornell University

• Cassandra Josephson, MD · Emory University

• Paul Ness, MD · Johns Hopkins University

• Sherrill Slichter, MD · University of Washington

• Thomas Price, MD · Bloodworks

• Ronald Strauss, MD · University of Iowa

• Jeffrey McCullough, MD · University of Minnesota

• James George, MD · University of Oklahoma

• Bruce Sachais, MD, PHD · University of Pennsylvania

• David Friedman, MD · Children's Hospital of Philadelphia

• Darrell Triulzi, MD · University of Pittsburgh Presbyterian and Shadyside/Children's Hospital Pittsburgh

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-04-30

Primary Completion

2013-04-30

Completion

2013-05-31

Countries

• United States

Study Locations