Ruxolitinib and Steroid As First Line Therapy for Acute GVHD

NCT ID: NCT03701698

Last Updated: 2024-10-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-01
• Study Completion Date: 2024-09-20

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.

Conditions

Acute GVHD

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

combination therapy

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.

Group Type: EXPERIMENTAL

Ruxolitinib Oral Tablet

Intervention Type: DRUG

Ruxolitinib Oral Tablet （Jakafi）, 5\~10mg bid po for at least 28 days.

Methylprednisolone

Intervention Type: DRUG

Methylprednisolone: 2mg/kg/d , iv or iv gtt, for at least 1 week, then taper accordingly.

Interventions

Ruxolitinib Oral Tablet

Ruxolitinib Oral Tablet （Jakafi）, 5\~10mg bid po for at least 28 days.

Intervention Type: DRUG

Methylprednisolone

Methylprednisolone: 2mg/kg/d , iv or iv gtt, for at least 1 week, then taper accordingly.

Intervention Type: DRUG

Other Intervention Names

Jakafi; steroid

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Xianmin Song, MD

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xianmin Song, M.D.

Role: PRINCIPAL_INVESTIGATOR

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Locations

Shanghai General Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

SHSYXY-Ruxo-GVHD-2018001

Identifier Type: -

Identifier Source: org_study_id