The purpose of this study is to determine the efficacy and safety of combined Ruxolitinib With Corticosteroids as First Line Therapy for the severe acute GVHD (graft-versus-host disease )
Acute graft-versus-host disease (GVHD) is treated with systemic corticosteroid immunosuppression as first line therapy. Many patients with severe acute GVHD do not respond to primary therapy, high-dose systemic corticosteroids; therefore, survival for those patients remains particularly poor. Here we determine the efficacy and safety of combined Ruxolitinib With Corticosteroids as First Line Therapy for the Treatment of severe acute GVHD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
54
Participants began oral administration of ruxolitinib at 5 mg QD; Methylprednisolone (1mg/kg)
Methylprednisolone 2mg/kg/d , iv or iv gtt for at least 1 week, then taper according to the clinical response.
Department of Hematology, the Fifth Center of Chinese PLA General Hospital
Beijing, China
RECRUITINGOverall response rate (ORR) at Day 28
Defined as the proportion of participants demonstrating a complete response (CR), and partial response (PR).
Time frame: Day 28 after treatment
Six-month duration of response
Defined as the time from first response until graft-versus-host disease (GVHD) progression or death. Six-month duration of response will be assessed when all participants who are still on study complete the Day 180 visit.
Time frame: Six-month after treatment
Ninety-day duration of response
Defined as the time from first response until GVHD progression or death, when all participants who are still on study complete the Day 90 visit.
Time frame: Day 90 after treatment
Nonrelapse mortality (NRM)
NRM was defined as death from any cause without relapse. Cumulative incidence of NRM was analyzed in a competing risk framework using Gray's method.
Time frame: 1 year after treatment
Cumulative incidence of relapse
Defined as the proportion of participants whose underlying malignancy relapsed.Relapse was defined as hematologic recurrence of malignancies after transplantation. Cumulative incidence of relapse was analyzed in a competing risk framework using Gray's method.
Time frame: 1 year after treatment
Disease-free survival (DFS)
Defined as the time from first dose of ruxolitinib to the earliest date that a participant died, had a relapse/progression of the underlying malignancy, required additional therapy for aGVHD, or demonstrated signs or symptoms of chronic graft-versus-host disease (cGVHD).DFS will be evaluated in an intent-to-treat analysis by Kaplan Meier estimate and Log Rank test. Survival will be calculated from the date of randomization.
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Time frame: 1 year after treatment
GVHD-free and relapse-free survival (GRFS)
GRFS was defined as the time onset of grade 3 to 4 aGVHD, moderate to severe cGVHD, or relapse/disease progression/death. GRFS will be evaluated in an intent-to-treat analysis by Kaplan Meier estimate and Log Rank test.
Time frame: 1 year after treatment
recurrence of aGVHD
Defined as the proportion of participants whose aGVHD relapsed.Relapse was defined as recurrence of new GVHD related symptoms after complete remission of aGVHD. Cumulative incidence of recurrence of aGVHD was analyzed in a competing risk framework using Gray's method.
Time frame: 1 year after treatment
Failure-free survival
Failure-free survival (FFS) refers to the time from randomization to disease relapse or progression, non-relapse mortality, or the addition of new therapy for aGVHD.
Time frame: 1 year after treatment