Acute GVHD Clinical Trial
Official title:
Ruxolitinib and Methylprednisolone as First Line Therapy for Acute Graft Versus Host Disease Following Allogeneic Stem Cell Transplantation
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).
Status | Not yet recruiting |
Enrollment | 30 |
Est. completion date | October 31, 2021 |
Est. primary completion date | October 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
China | Shanghai General Hospital | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | overall response rate | overall response rate of acute GVHD treatment, including complete response rate and partial response rate after combination therapy. | 28 days after treatment | |
Secondary | time to response | days from beginning to the first day of maximum response | 28 days after treatment | |
Secondary | reactivation rate of cytomegalovirus | reactivation rate of cytomegalovirus infection | 100 days within transplant | |
Secondary | 1 year incidence of chronic GVHD | incidence of chronic GVHD 1 year after transplant | 1 year within transplant |
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