The purpose of the study is to assess the efficacy and safety of ruxolitinib in Chinese adult and pediatric participants aged 12 years or older with corticosteroid-refractory chronic graft vs. host disease (SR-cGvHD).
Signed informed consent must be obtained prior to participation in the study.
Male or female Chinese participants aged 12 or older at the time of informed consent
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. Recipients of non-myeloablative, myeloablative, and reduced intensity conditioning are eligible.
Absolute neutrophil count (ANC) >1,000/mm3 AND
Participants who have received two or more systemic treatments for cGvHD in addition to corticosteroids ± CNI for cGvHD.
Participants who have received ROCK2 inhibitors for cGvHD.
Participants that transition from active aGvHD to cGvHD without tapering off corticosteroids ± CNI and any systemic treatment
Participants who were treated with prior JAK inhibitors for aGvHD; except when the participant achieved complete or partial response and has been off JAK inhibitor treatment for at least 8 weeks prior to Cycle 1 Day 1.
Single group
Ruxolitinib
DrugRuxolitinib is taken orally daily at 10 mg BID, given as two 5 mg tablets.
Overall Response Rate (ORR)
ORR is defined as the percentage of participants demonstrating a complete response (CR) or partial response (PR) without the requirement of additional systemic therapies for an earlier progression, mixed response or non-response, according to National Institute of Health (NIH) Consensus Criteria.
Failure-free Survival (FFS)
FFS is defined as the time from the date of start of study treatment to the earliest of: i) relapse or recurrence of underlying disease or death due to underlying disease, ii) nonrelapse mortality, or iii) addition or initiation of another systemic therapy for cGvHD.
Best Overall Response (BOR)
Percentage of participants who achieved overall response (CR+PR) at any time point (up Cycle 7 Day 1 or the start of additional systemic therapy for cGvHD).
ORR at end of cycle 3
Percentage of participants who achieved overall response (CR+PR) at Cycle 4 Day 1.
Duration of Response (DOR)
DOR is assessed for responders only and is defined as the time from first response until cGvHD progression, death, or the date of addition of systemic therapies for cGvHD.
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