Acute GVHD
Conditions
Brief 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.
Interventions
Ruxolitinib Oral Tablet （Jakafi）, 5\ 10mg bid po for at least 28 days.
DRUGMethylprednisolone
Methylprednisolone: 2mg/kg/d , iv or iv gtt, for at least 1 week, then taper accordingly.
Sponsors
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| overall response rate | 28 days after treatment | overall response rate of acute GVHD treatment, including complete response rate and partial response rate after combination therapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| time to response | 28 days after treatment | days from beginning to the first day of maximum response |
| reactivation rate of cytomegalovirus | 100 days within transplant | reactivation rate of cytomegalovirus infection |
| 1 year incidence of chronic GVHD | 1 year within transplant | incidence of chronic GVHD 1 year after transplant |
Countries
China
Outcome results
None listed