MedTrace Logo

First Line Therapy for High Risk Acute GVHD

NCT04061876 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 198

Last updated 2023-11-29

No results posted yet for this study

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 )

Conditions

  • aGVHD
  • Stem Cell Transplant Complications

Interventions

DRUG

Ruxolitinib

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.

DRUG

Corticosteroid

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.

Sponsors & Collaborators

  • LU DAOPEI MEDICAL

    collaborator UNKNOWN

  • 960th Hospital of PLA

    collaborator UNKNOWN

  • The Second Hospital of Hebei Medical University

    collaborator OTHER

  • The Second Affiliated Hospital of Dalian Medical University

    collaborator OTHER

  • Air Force Military Medical University, China

    collaborator OTHER

  • Chinese PLA General Hospital

    lead OTHER

Principal Investigators

  • Daihong Liu · Chines PLA General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-25
Primary Completion
2022-08-01
Completion
2023-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04061876 on ClinicalTrials.gov