CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 198 enrolled
Drug / intervention
Ruxolitinib +1 moredrug
Likely dose
Ruxolitinib 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04061876
NCT04061876Phase 2Completed

Ruxolitinib in Combination With Corticosteroid as First Line Therapy for the Treatment of High Risk Acute Graft-Versus-Host Disease

Chinese PLA General Hospital·interventional·Posted Aug 20, 2019·Updated Nov 29, 2023

In Brief

A Phase 2 clinical trial evaluating Ruxolitinib and Corticosteroid for aGVHD and Stem Cell Transplant Complications. Completed, enrolled 198 participants across 1 site.

Detailed Summary

The purpose of this study is to determine the efficacy and safety of combined Ruxolitinib With Corticosteroids as First Line Therapy for the Treatment of High risk aGVHD(acute graft-versus-host disease )

Study Details

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedAug 20, 2019
Enrollment StartAug 25, 2019
Primary CompletionAug 1, 2022
Study CompletionJun 30, 2023
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 6.9 years ago

Interventions

Ruxolitinibdrug

Participants began oral administration of ruxolitinib at 5 mg QD;Methylprednisolone: 1mg/kg/d , iv or iv gtt for at least 5 days, then taper according to the clinical response.

Corticosteroiddrug

Methylprednisolone: 2mg/kg/d , iv or iv gtt for at least 3 days, then taper according to the clinical response. 1mg/kg/d , iv or iv gtt for at least 5 days, then taper according to the clinical response.