Ruxolitinib and Steroid As First Line Therapy for Acute GVHD
NCT03701698 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1
Last updated 2024-10-01
Summary
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).
Conditions
- Acute GVHD
Interventions
- DRUG
-
Ruxolitinib Oral Tablet
Ruxolitinib Oral Tablet (Jakafi), 5\~10mg bid po for at least 28 days.
- DRUG
-
Methylprednisolone
Methylprednisolone: 2mg/kg/d , iv or iv gtt, for at least 1 week, then taper accordingly.
Sponsors & Collaborators
-
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
lead OTHER
Principal Investigators
-
Xianmin Song, M.D. · Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Study Design
- Allocation
- NA
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-11-01
- Primary Completion
- 2024-09-20
- Completion
- 2024-09-20
- FDA Drug
- Yes
Countries
- China
Study Locations
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