Ruxolitinib and Steroid As First Line Therapy for Acute GVHD
- Conditions
- Acute GVHD
- Interventions
- Registration Number
- NCT03701698
- Lead Sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1
- diagnosed with hematological diseases.
- recipients of allogeneic peripheral blood stem cell transplantation.
- new onset of grade II~IV acute graft versus host disease within 100 days post-transplantation.
exclusion criteria:
- recipients of second allogeneic stem cell transplant.
- acute GVHD induced by donor lymphocyte infusion, interferon.
- received treatment other than steroid before enrollment.
- overlap GVHD syndrome.
- pregnant or breast-feeding women.
- absolute neutrophil count (ANC) <0.5×10e9/L or platelet count (PLT) < 20×10e9/L
- non-GVHD related liver dysfunction: glutamic pyruvic transaminase>= 4 times of upper normal limit, direct bilirubin >= 4 times of upper normal limit
- renal dysfunction: creatinine clearance < 15 mL/min or glomerular filtration rate< 15 mL/min
- uncontrolled infection
- human immunodeficiency virus infection
- active hepatitis b virus, hepatitis C virus infection and need antivirus treatment.
- relapse of primary malignant hematological diseases, or graft rejection.
- allergic history to Janus kinase inhibitors.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description combination therapy Ruxolitinib Oral Tablet There is only 1 arm. Combination therapy arm includes ruxolitinib and methylprednisolone. 1. Methylprednisolone: 2mg/kg/d , iv or iv gtt for at least 1 week, then taper according to the clinical response. 2. Ruxolitinib oral tablet, 5\~10mg bid orally, for at least 28 days. combination therapy Methylprednisolone There is only 1 arm. Combination therapy arm includes ruxolitinib and methylprednisolone. 1. Methylprednisolone: 2mg/kg/d , iv or iv gtt for at least 1 week, then taper according to the clinical response. 2. Ruxolitinib oral tablet, 5\~10mg bid orally, for at least 28 days.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 1 year incidence of chronic GVHD 1 year within transplant incidence of chronic GVHD 1 year after transplant
reactivation rate of cytomegalovirus 100 days within transplant reactivation rate of cytomegalovirus infection
time to response 28 days after treatment days from beginning to the first day of maximum response
Trial Locations
- Locations (1)
Shanghai General Hospital
🇨🇳Shanghai, Shanghai, China