drugset
drugset / Trial / NCT04269850

Fecal Microbiota Transplantation With Ruxolitinib and Steroids as an Upfront Treatment of Severe Acute Intestinal GVHD

NCT04269850 ↗

Phase 1/2 Terminated 2 enrolled St. Petersburg State Pavlov Medical University
NaSingle-groupOpen-labelTreatment

Summary

Therapy of severe intestinal graft-versus-host disease (GVHD) despite the introduction of novel target agents is associated with worse outcome compared to the other forms. Response to steroids is observed only in about 10% of patients. The most promising approaches are JAK inhibition and fecal microbiota transplantation. In this pilot study we evaluate this combination treatment in the first line.

Timeline

Start
2019-09-01
Primary completion
2024-11-27
Completion
2024-11-27

Drugs

EvaluationDrugModalityDoseRoute
Subject Methylprednisone Unknown 0.5 mg/kg Intravenous
Subject Ruxolitinib Small molecule 10 mg —
Subject allogeneic fecal microbiota Other / unclassified 2 unknown —

Indications

acute graft versus host disease