Ruxolitinib and Steroid as First Line Therapy for Acute GVHD

Shanghai Jiao Tong University

Status and phase: Unknown; Phase 2

Conditions: Acute GVHD

Treatments: Drug: Methylprednisolone; Drug: Ruxolitinib Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT03701698

SHSYXY-Ruxo-GVHD-2018001

Details and patient eligibility

About

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).

Full description

Treatment:

Once patients are diagnosed with grade II~IV acute GVHD, the combination therapy should be initiated as soon as possible.

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. 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:

No response after ruxolitinib treatment for 28 days. Develop life-threatening complication. ANC<0.5×10e9/L or PLT< 20×10e9/L.

Indication for second line acute GVHD treatment:

deterioration of acute GVHD in 3 days no response after 7 days no complete remission after 2 weeks.

Suggestions of second line therapy:

Basiliximab 20mg, d1, d4, d8.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

combination therapy

Experimental group

Description:

There is only 1 arm. Combination therapy arm includes ruxolitinib and methylprednisolone. Methylprednisolone: 2mg/kg/d , iv or iv gtt for at least 1 week, then taper according to the clinical response. Ruxolitinib oral tablet, 5~10mg bid orally, for at least 28 days.

Treatment:

Drug: Ruxolitinib Oral Tablet

Drug: Methylprednisolone