Low Dose Ruxolitinib in Combination With Methylprednisolone

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

38

Participants

Timeline

Start Date

January 1, 2019

Primary Completion Date

July 1, 2020

Study Completion Date

December 31, 2020

Conditions
aGVHDStem Cell Transplant Complications
Interventions
DRUG

Ruxolitinib 10 mg twice a day combined with Corticosteroids

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.

DRUG

Ruxolitinib 5 mg twice a day combined with Corticosteroids

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.

DRUG

Ruxolitinib 5 mg once a day combined with Corticosteroids

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.

DRUG

Ruxolitinib 2.5 mg once a day combined with Corticosteroids

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.

Trial Locations (1)

100853

Chinese PLA General Hospital, Beijing

All Listed Sponsors
lead

Chinese PLA General Hospital

OTHER

NCT04397367 - Low Dose Ruxolitinib in Combination With Methylprednisolone | Biotech Hunter | Biotech Hunter