Ruxolitinib and Steroid as First Line Therapy for Acute GVHD

Acute GVHD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03701698
• Other study ID #: SHSYXY-Ruxo-GVHD-2018001
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: November 1, 2018
• Est. completion date: October 31, 2021

Study information

• Verified date: October 2018
• Source: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: Liping Wan, M.D.
• Phone: 86-21-37798987
• Email: lipingwan[@]sjtu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• 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.

Related Conditions & MeSH terms

• Acute GVHD

Intervention

Drug:
• Ruxolitinib Oral Tablet
Ruxolitinib Oral Tablet (Jakafi), 5~10mg bid po for at least 28 days.
• Methylprednisolone
Methylprednisolone: 2mg/kg/d , iv or iv gtt, for at least 1 week, then taper accordingly.

Locations

Country	Name	City	State
China	Shanghai General Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

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