NCT03701698

Ruxolitinib and Steroid As First Line Therapy for Acute GVHD

Ruxolitinib and Methylprednisolone As First Line Therapy for Acute Graft Versus Host Disease Following Allogeneic Stem Cell Transplantation

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Acute GVHD

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-11-01
• Primary completion: 2024-09-20
• Completion: 2024-09-20
• First posted: 2018-10-10
• Last updated: 2024-10-01

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study