This is an open, multi-center clinical study designed to evaluate the efficacy and safety of TQ05105 Tablets in patients with chronic graft-versus-host disease
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
65
Rovadicitinib (TQ05105) is a novel, oral dual JAK 1/2 and Rho-associated kinases (ROCK) 1/2 inhibitor targeting inflammatory and fibrotic components of cGVHD.
Anhui Provincial Hospital
Hefei, Anhui, China
NOT_YET_RECRUITINGThe 940th hospital of joint logistics support force of Chinese people's liberation army
Lanzhou, Gansu, China
Objective response rate (ORR) at 24 weeks
Percentage of subjects with an overall response of all evaluable organs as complete response (CR) or partial response (PR).
Time frame: Up to 24 weeks
Best objective response rate (BOR)
Proportion of subjects achieving CR+PR and at any time point prior to initiation of other systemic therapies for cGVHD
Time frame: Up to 96 weeks
Duration of response (DOR)
Time to first response to cGVHD disease progression, death, or initiation of any new systemic therapy for cGVHD
Time frame: Up to 96 weeks
Failure-free survival (FFS)
The time from the first dose to the time of recurrence, death, or death or increase in non-original disease or initiation of a new cGVHD systemic
Time frame: Up to 96 weeks
Incidence rate of malignancy relapse or recurrence
Proportion of subjects with recurrence date of blood system disease from the first dose
Time frame: Up to 96 weeks
Non relapse mortality
From first dose to the date of death, with no recurrence of the original disease
Time frame: At least 96 weeks
Overall Survival (OS)
Time from first dose to death caused by various reasons
Time frame: At least 96 weeks
Adverse event rate
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Guangzhou First People's Hospital
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
NOT_YET_RECRUITINGThe Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
NOT_YET_RECRUITINGXiangyang Central Hospital
Xiangyang, Hubei, China
NOT_YET_RECRUITINGTai'an Central Hospital
Taian, Shangdong, China
NOT_YET_RECRUITINGRuijin Hospital affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
NOT_YET_RECRUITINGThe Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shannxi, China
NOT_YET_RECRUITINGHematology Hospital of the Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China
NOT_YET_RECRUITING...and 2 more locations
The occurrence of all adverse events (AEs), serious adverse events (SAEs) , evaluated according to the Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0)
Time frame: Up to 96 weeks
Severity of adverse events (AEs)
Severity of all adverse medical events that occur after the subject receives the investigational drug, evaluated according to the Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0)
Time frame: Up to 48 weeks