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

Status: Recruiting
Phase: Phase 3
Diagnosis: Pediatric Hematology/Blood Related
NCT ID: NCT00627393 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 09-106

 

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.

 

Conducting Institutions:
Children's Hospital Boston, Dana-Farber Cancer Institute, Brigham and Women's Hospital

Overall PI:
Steven Sloan, MD, Children's Hospital Boston

Site-responsible Investigators:

Contacts:
Dana-Farber Cancer Institute: Childrens Hospital Pediatric Clinical Translation Investigation Program CTIP, ctip@partners.org

Eligibility Criteria

Inclusion Criteria: - Undergone dose-intensive chemotherapy or HSC transplantation within 60 days before study entry - Diagnosis of neutropenia (absolute neutrophil count less than 500 cells/mm3) and is expected to remain neutropenic for at least 5 days after study entry - Must have one of the following: fungemia, bacteremia, invasive tissue bacterial infection, proven invasive tissue fungal infection, or probable invasive tissue fungal infection (Note: patients with criteria meeting only the definition for a possible invasive fungal infection are not eligible to participate) Exclusion Criteria: - Unlikely to survive 5 days - Previously enrolled in this study
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