Ruxolitinib and Steroid as First Line Therapy for Acute GVHD

Acute GVHD Clinical Trial

Official title: Ruxolitinib and Methylprednisolone as First Line Therapy for Acute Graft Versus Host Disease Following Allogeneic Stem Cell Transplantation

Status Not yet recruiting

Clinical Trial 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).

Clinical Trial Description

Treatment:

Once patients are diagnosed with grade II~IV acute GVHD, the combination therapy should be initiated as soon as possible.

1. Methylprednisolone: 2mg/kg/d, iv or iv gtt, in two or three divided doses. Taper steroid every one or two weeks according to patient's response.

2. Ruxolitinib 5~10mg bid po for at least 28 days. If patient's ANC<0.5×10e9/L or PLT< 20×10e9/L, cease ruxolitinib until recovery of ANC higher than 0.5×10e9/L or PLT higher than 20×10e9/L.

Indication for stopping Ruxolitinib treatment:

1. No response after ruxolitinib treatment for 28 days.

2. Develop life-threatening complication.

3. ANC<0.5×10e9/L or PLT< 20×10e9/L.

Indication for second line acute GVHD treatment:

1. deterioration of acute GVHD in 3 days

2. no response after 7 days

3. no complete remission after 2 weeks.

Suggestions of second line therapy:

Basiliximab 20mg, d1, d4, d8. ;

Related Conditions & MeSH terms

• Acute GVHD

• NCT number: NCT03701698
• Study type: Interventional
• Source: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: Liping Wan, M.D.
• Phone: 86-21-37798987
• Email: lipingwan@sjtu.edu.cn
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: November 1, 2018
• Completion date: October 31, 2021