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Granulocyte transfusions · 1 trial · 2 indications
Microbial response was defined as follows: * A negative blood culture test at 42 days after randomization for subjects with fungemia (candidemia or fusariosis) or bacteremia. * Improvement of signs and symptoms of infectious disease (complete or partial response) at 42 days after randomization.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Participants will receive granulocyte transfusions in addition to standard antimicrobial therapy |
| 2 | ACTIVE_COMPARATOR | Participants will receive standard antimicrobial therapy alone |
| 3 | OTHER | Participants will donate granulocytes after receiving a combination of two drugs, G-CSF and dexamethasone |
| Name | Type | Description |
|---|---|---|
| Standard antimicrobial therapy | DRUG | 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. |
| Granulocyte transfusions | BIOLOGICAL | 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). |
| G-CSF/dexamethasone | DRUG | Twelve hours before each donation, participants will be injected with G-CSF and will take one dose of dexamethasone by mouth. |
| Apheresis machine | DEVICE | 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. |
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 inva...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| X4 Pharmaceuticals, Inc. | XFOR | 1 | PHASE3 | Mavorixafor |
Granulocyte transfusions are used to treat infection in people with neutropenia, a condition marked by abnormally low levels of neutrophils, a type of white blood cell. The approach is intended to help resolve infection in patients whose own neutrophil counts are too low to fight it effectively.
Elevance Health, Inc. (ticker ELV) is the developer associated with Granulocyte transfusions. The program is in Phase 3 development in hematology, with neutropenia as the indication studied.
Granulocyte transfusions are in Phase 3 development. The program has one completed Phase 3 trial and no active trials. Because the available record shows only completed clinical development, the therapy is investigational rather than approved.
The RING Study, registered as NCT00627393, evaluated the safety and effectiveness of granulocyte transfusions in resolving infection in people with neutropenia. It was a Phase 3, randomized, active-controlled trial that enrolled 114 participants in the United States and has completed.
NCT00627393 was a Phase 3, randomized, active-controlled trial of granulocyte transfusions in patients with neutropenia and infection. It enrolled 114 participants of all sexes in the United States, was not double-blind, and did not select patients by biomarker. The study has completed.