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Chronic graft anti-host disease (cGVHD) is an important cause of non-recurrence mortality and functional disorders in patients with hematopoietic stem cell transplantation (HCT).
current standard system therapy for moderate to severe cGVHD is glucosal hormone-combined or non-combined neurocalculum protein inhibitors.
, however, about half of patients end up with hormone insensitiveness.
cGVHD is still an important challenge in clinical work.
hardened skin is particularly difficult to treat.
Curtis, etc., conducted a random phase 2 clinical trial to determine the safety, effectiveness, and preferred dose of Pomalidomide in patients with moderate-severe cGVHD who are insensitive to glucosticoids and/or follow-up treatments.
(study process) 34 subjects were randomly assigned to the 0.5 mg group (Pomadamine 0.5 mg/day, oral, n=17) or 2 mg group (starting at 0.5 mg/day, gradually added to 2 mg/day for 6 consecutive weeks, n=17).
end point is the total mitigation rate (ORR) at 6 months.
(remission) 32 patients had severely hardened skin and had received a medium 5 systematic treatment (range 2-10).
in intent therapy analysis, the ORR was 47% (95% CI, 30-65%).
all patients were partially relieved and there was no difference in ORR between the queues.
six months, the ORR of the 24 assessable subjects was 67% (45-84%).
NIH joint/fascia scores improved in 9 of these positions (p-0.018).
area of cGvHD of the affected skin decreased by 7.5% compared to the median of the baseline (-10 to -35; p=0.002).
adverse events (AEs) in lymphocytes (adverse reactions level 2 and above) are lymphocyte reduction, infection and fatigue.
8 subjects in the 2 mg group were treated with dose reduction due to adverse reactions.
one person in the 0.5 mg group died of bacterial pneumonia.
, the study suggests that the antifibrosis effects of pomadamine may be associated with elevated concentrations of regulated T cells and IL-2 in the blood.
, 0.5 mg/day, is a safe and effective method for treating the incurable cGVHD of late-stage glucoticoids.
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