Phase 3
N=114
Safety and Effectiveness of Granulocyte Transfusions in Resolving Infection in People With Neutropenia (The RING Study)
Neutropenia · Infection
Bottom Line
View on ClinicalTrials.gov: NCT00627393 ↗Enrolled (actual)
114
Serious AEs
44.7%
Results posted
Dec 2014
Primary outcome: Primary: Percentage of Participants Who Are Alive at 42 Days After Treatment and Have Had Microbial Response — 42.9; 41.7 percentage of participants — p=0.73
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Standard antimicrobial therapy (Drug); Granulocyte transfusions (Biological); G-CSF/dexamethasone (Drug); Apheresis machine (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Carelon Research
- Primary completion
- Apr 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Are Alive at 42 Days After Treatment and Have Had Microbial Response |
42.9; 41.7 | 0.73 |
| SECONDARY Alloimmunization, Defined as the Appearance of Anti-human Leukocyte Antigen (HLA) or Antineutrophil Antibodies |
— | — |
| SECONDARY Serious Granulocyte Transfusion Reactions, Including Febrile, Allergic, and Pulmonary Reactions (Transfusion Arm Only) |
5; 19; 0; 7; 1; 14 | — |
| SECONDARY Graft Versus Host Disease Among Recipients of Allogeneic Stem Cell Transplantation |
0.67; 0.40 | 0.43 |
| SECONDARY Overall Incidence of Adverse Effects |
33; 30; 21; 20; 2; 5 | — |
| SECONDARY Fever Resolution |
0.89; 0.94 | — |
| SECONDARY Time to Negative Test for Fungal Antigenemia (e.g., Galactomannan Antigenemia Among Participants With Invasive Aspergillosis) |
— | — |
| SECONDARY Time to Negative Blood Culture for Participants With Positive Blood Culture at Baseline |
— | — |
| SECONDARY Long-term Survival |
30; 20 | 0.35 |
| SECONDARY Serious Adverse Events in Granulocyte Donors |
1; 1 | — |
| SECONDARY Donor Availability (Proportion of Scheduled Granulocyte Transfusion Days on Which Granulocytes Were Available) |
62.62 | — |
| SECONDARY Evaluation of Granulocyte Yield |
174.75 | — |
| SECONDARY Discontinuation of Granulocyte Transfusions Due to Toxicity or Intolerance |
— | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00627393). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.