Ruxolitinib and Steroid As First Line Therapy for Acute GVHD

Sponsor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Study ID
NCT03701698
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Ruxolitinib Oral Tablet — DRUG
    Ruxolitinib Oral Tablet （Jakafi）, 5\~10mg bid po for at least 28 days.
  • Methylprednisolone — DRUG
    Methylprednisolone: 2mg/kg/d , iv or iv gtt, for at least 1 week, then taper accordingly.

Study Details

The purpose of this study is to evaluate the efficacy of ruxolitinib in combination with methylprednisolone as first line therapy in patients with Grades II to IV acute graft-versus-host disease (GVHD).

Key Dates

Start date
Nov 1, 2018
Status verified
Sep 2024
Primary completion
Sep 20, 2024
Completion
Sep 20, 2024

Study Design

Enrollment
1 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: combination therapy
    There is only 1 arm. Combination therapy arm includes ruxolitinib and methylprednisolone. 1. Methylprednisolone: 2mg/kg/d , iv or iv gtt for at least 1 week, then taper according to the clinical response. 2. Ruxolitinib oral tablet, 5\~10mg bid orally, for at least 28 days.

Primary Outcome Measure

overall response rate [ Time Frame: 28 days after treatment ]

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