This study aims to investigate the efficacy and safety of Golidocitinib(GO) monotherapy in the treatment of hemophagocytic lymphohistiocytosis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Administer the GO regimen to HLH patients who meet the inclusion criteria, specifically Golicitinib 150 mg once daily.
beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGEvaluation of treatment response
A complete response was defined as normalization of all of the quantifiable symptoms and laboratory markers of HLH, including levels of sCD25, ferritin, triglyceride, blood cell count, hemophagocytosis, and level of consciousness (if CNS HLH is present). A partial response was defined as at least a 25% improvement in 2 or more quantifiable symptoms and laboratory markers as follows: sCD25 response was\>1.5-fold decreased; ferritin and triglyceride decreased at least 25%; without blood transfusion: Neutrophils \<500/ml must increase by 100% and be \>500/ml; neutrophils 500-2000/ml must increase by 100% and return to normal.; and for patients with ALT \>400 U/L, response was defined as an ALT decrease of at least 50%. No response is defined as not meeting the criteria for partial response.
Time frame: Weeks 2, 4, 6, and 8 after the start of treatment
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
An adverse event is defined as an adverse medical condition (including worsening of a pre-existing condition) that occurs in a subject or clinical trial subject after receiving medication, regardless of whether it is causally related to the investigational drug. Serious adverse events are defined as AEs that meet one or more of the following criteria during any study period: death; immediate threat to life; and hospitalization or prolongation of hospitalization.
Time frame: 30 days after the last dose is administered.
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