First Line Therapy for High Risk Acute GVHD

Sponsor
Chinese PLA General Hospital
Study ID
NCT04061876
Phase
PHASE2
Status
Completed

Conditions

  • Stem Cell Transplant Complications
  • aGVHD

Eligibility Criteria

Sex
ALL
Age
14 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Ruxolitinib — DRUG
    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.
  • Corticosteroid — DRUG
    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.

Study Details

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 )

Key Dates

Start date
Aug 25, 2019
Status verified
Nov 2023
Primary completion
Aug 1, 2022
Completion
Jun 30, 2023

Study Design

Enrollment
198 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ruxolitinib combined with Corticosteroids
    Participants began oral administration of ruxolitinib at 5 mg QD; Methylprednisolone: 1mg/kg/d , iv or iv gtt for at leas 5 days, then taper according to the clinical response.
  • Active Comparator: Corticosteroids
    Methylprednisolone: 2mg/kg/d , iv or iv gtt for at least 1 week, then taper according to the clinical response.

Primary Outcome Measure

Overall response rate (ORR) at Day 28 [ Time Frame: Day 28 after treatment ]

Related Studies