Ruxolitinib and Steroid as First Line Therapy for Acute GVHD

Shanghai Jiao Tong University logo

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

  • 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.

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

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

Trial contacts and locations

0

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Central trial contact

Liping Wan, M.D.; Jieling Jiang, M.D.

Data sourced from clinicaltrials.gov

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