The purpose of this study is to determine the efficacy and safety of combined Ruxolitinib With Corticosteroids as First Line Therapy for grade II 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 grade II 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 grade II acute GVHD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
168
Participants began oral administration of ruxolitinib at 5 mg QD;Methylprednisolone: 0.5mg/kg/d , iv or iv gtt for at least 5 days, then taper according to the clinical response.
Methylprednisolone: 2mg/kg/d , iv or iv gtt for at least 1 week, then taper according to the clinical response.
Department of Hematology, Senior Department of Hematology, The Fifth Medical Center of PLA General Hospital
Beijing, Beijing Municipality, China
RECRUITINGOverall response rate (ORR) at Day 28
Defined as the proportion of participants demonstrating a complete response (CR), or 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
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 (CIR)
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 day +1 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.
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Time frame: 1 year after treatment
Overall survival (OS)
Defined as survival from day +1 until death or last follow-up. OS 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.
Time frame: 1 year after treatment
GVHD-free and relapse-free survival (GRFS)
Defined as a composite endpoint of death from any cause, disease relapse, grade Ⅲ-Ⅳ acute GVHD, or chronic GVHD requiring systemic immunosuppression therapy.
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 day +1 to disease relapse or progression, non-relapse mortality, or the addition of new therapy for aGVHD.
Time frame: 1 year after treatment