Low Dose Ruxolitinib in Combination With Methylprednisolone
Condition: aGVHD; Stem Cell Transplant Complications
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study is to determine the efficacy and safety of combined Low dose Ruxolitinib With
      Methylprednisone as Initial Therapy for the aGVHD(acute graft-versus-host disease )
    

Detailed description: 
      Corticosteroid is used as a first-line treatment for acute GVHD. However, it is effective in
      only about half of patients. In this prospective study, the investigators prospectively
      combined low dose ruxolitinib and 1mg/kg methylprednisolone in the initial treatment of acute
      GVHD. In order to effectively control GVHD without exposing acute GVHD patients to more
      intense and prolonged immunosuppression, we used ruxolitinib (20mg/day, 10mg/day, 5mg/day,
      2.5mg/day) combined with 1mg/kg methylprednisolone. To ally steroid-related complications, we
      decreased steroid exposure time (39 days) and cumulative methylprednisolone doses (15.4
      mg/kg) to spare the associated toxicity of glucocorticoid therapy.
    

Intervention name(s): Ruxolitinib 10 mg twice a day combined with Corticosteroids; Ruxolitinib 5 mg twice a day combined with Corticosteroids; Ruxolitinib 5 mg once a day combined with Corticosteroids; Ruxolitinib 2.5 mg once a day combined with Corticosteroids
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Newly diagnosed acute GVHD patients started therapy with methylprednisolone of 1 mg/kg/day after diagnosis. Ruxolitinib was administered at a median of 2 days after the use of methylprednisolone. Participants began oral administration of ruxolitinib at 10 mg twice a day. Ruxolitinib was subsequently tapered due to the resolution of acute GVHD after three months of therapy. A dose-tapering schedule that would discontinue ruxolitinib in three months was recommended.; Newly diagnosed acute GVHD patients started therapy with methylprednisolone of 1 mg/kg/day after diagnosis. Ruxolitinib was administered at a median of 2 days after the use of methylprednisolone. Participants began oral administration of ruxolitinib at 5 mg twice a day. Ruxolitinib was subsequently tapered due to the resolution of acute GVHD after three months of therapy. A dose-tapering schedule that would discontinue ruxolitinib in three months was recommended.; Newly diagnosed acute GVHD patients started therapy with methylprednisolone of 1 mg/kg/day after diagnosis. Ruxolitinib was administered at a median of 2 days after the use of methylprednisolone. Participants began oral administration of ruxolitinib at 5 mg once a day. Ruxolitinib was subsequently tapered due to the resolution of acute GVHD after three months of therapy. A dose-tapering schedule that would discontinue ruxolitinib in three months was recommended.; Newly diagnosed acute GVHD patients started therapy with methylprednisolone of 1 mg/kg/day after diagnosis. Ruxolitinib was administered at a median of 2 days after the use of methylprednisolone. Participants began oral administration of ruxolitinib at 2.5 mg once a day. Ruxolitinib was subsequently tapered due to the resolution of acute GVHD after three months of therapy. A dose-tapering schedule that would discontinue ruxolitinib in three months was recommended.
Other intervention name(s): ruxolitinib 10 mg twice a day; ruxolitinib 5 mg twice a day; Ruxolitinib 5 mg once a day; Ruxolitinib 2.5 mg once a day
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment