Ruxolitinib and Steroid as First Line Therapy for Acute GVHD

• Status: Unknown status
• Trial end date: 2021-10-31
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
• Treatments: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

Inclusion Criteria:

1. diagnosed with hematological diseases.

2. recipients of allogeneic peripheral blood stem cell transplantation.

3. new onset of grade II~IV acute graft versus host disease within 100 days post-transplantation.

exclusion criteria:

1. recipients of second allogeneic stem cell transplant.

2. acute GVHD induced by donor lymphocyte infusion, interferon.

3. received treatment other than steroid before enrollment.

4. overlap GVHD syndrome.

5. pregnant or breast-feeding women.

6. absolute neutrophil count (ANC) <0.5×10e9/L or platelet count (PLT) < 20×10e9/L

7. non-GVHD related liver dysfunction: glutamic pyruvic transaminase>= 4 times of upper normal limit, direct bilirubin >= 4 times of upper normal limit

8. renal dysfunction: creatinine clearance < 15 mL/min or glomerular filtration rate< 15 mL/min

9. uncontrolled infection

10. human immunodeficiency virus infection

11. active hepatitis b virus, hepatitis C virus infection and need antivirus treatment.

12. relapse of primary malignant hematological diseases, or graft rejection.

13. allergic history to Janus kinase inhibitors.