The purpose of this study is to assess the efficacy and safety of ruxolitinib therapy in Chinese adults and adolescents (≥ 12 years old) with Grade II-IV steroid-refractory acute graft versus host disease (SR-aGvHD).
Male or female Chinese participants aged 12 or older at the time of informed consent. Written informed consent from participant, parent or legal guardian.
Able to swallow tablets.
Have undergone alloSCT from any donor source (matched unrelated donor, sibling, haplo-identical) using bone marrow, peripheral blood stem cells, or cord blood.
Clinically diagnosed Grades II to IV acute GvHD as per standard criteria occurring after alloSCT requiring systemic immune suppressive therapy.
Has received more than one systemic treatment for steroid refractory aGvHD. Participants who received JAK inhibitor therapy for any indication after initiation of current alloSCT conditioning.
Clinical presentation resembling de novo chronic GvHD or GvHD overlap syndrome with both acute and chronic GvHD features.
Failed prior alloSCT within the past 6 months. Presence of relapsed primary malignancy after the alloSCT was performed.
Presence of an active uncontrolled infection including significant bacterial, fungal, viral or parasitic infection requiring treatment.
Single group
Ruxolitinib
DrugRuxolitinib is taken orally daily at 10 mg BID, given as two 5-mg tablets.
Overall Response Rate (ORR) at Day 28 per Investigators
The ORR at Day 28 defined as the percentage of participants demonstrating a complete response (CR) or partial response (PR) without requirement for additional systemic therapies for an earlier progression, mixed response or nonresponse, according to standard criteria and assessed by investigators.
Durable Overall response rate (ORR) at Day 56
Durable ORR at Day 56 is defined as the percentage of participants who achieve a complete response (CR) or partial response (PR) at Day 28 and maintain a CR or PR at Day 56.
Duration of Response (DOR)
DOR is defined as the time from first response until aGvHD progression or the date of additional systemic therapies for aGvHD.
Best overall response (BOR)
Percentage of participants who achieved overall response (complete response (CR) + Partial response (PR) at any time point up to and including Day 28 and before the start of additional systemic therapy for aGvHD.
Overall survival (OS)
Overall survival (OS) is defined as the time from the date of start of study treatment to date of death due to any cause.
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