NCT04146207

SHR0302 and Steroid As First Line Therapy for Chronic GVHD

SHR0302 and Prednisone As First Line Therapy for Chronic Graft Versus Host Disease Following Allogeneic Stem Cell Transplantation

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 28 (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 SHR0302 in combination with Prednisone as first line therapy in patients with moderate to severe chronic graft-versus-host disease (GVHD).

Detailed description

Treatment: Once patients are diagnosed with chronic GVHD, the combination therapy should be initiated as soon as possible. 1. Prednisone: 1mg/kg/d po. Taper steroid every two weeks according to patient's response. 2. SHR0302 QD po. for at least 28 days. Indication for stopping SHR0302 treatment: 1. No response after SHR0302 treatment for 12 weeks. 2. Develop life-threatening complication. 3. ANC\<0.5×10e9/L or PLT\< 30×10e9/L.

Conditions

• Chronic GVHD

Interventions

Type	Name	Description
DRUG	SHR0302	SHR0302 po QD
DRUG	Prednisone	Prednisone 1mg/kg/d po

Timeline

• Start date: 2020-04-02
• Primary completion: 2024-09-30
• Completion: 2024-10-31
• First posted: 2019-10-31
• Last updated: 2024-11-13

Locations

2 sites across 1 country: China