A Randomized, Open-label, Multicenter Phase II Clinical Trial of Rovadicitinib in the Treatment of Third-line and Subsequent Moderate to Severe Chronic Graft-versus-host Disease (cGVHD).
Status: Recruiting
Location: See all (12) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
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
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• Voluntary and signed informed consent, good compliance;
• Age 18-70 years old; Karnofsky Performance Scale (KPS) ≥60 points; Life expectancy ≥ 6months.
• Received allogeneic hematopoietic stem cell transplantation;
• Diagnosis of moderate-to-severe chronic graft-versus-host disease (cGVHD)
• Received systemic therapies for cGVHD;
• Stable dose of glucocorticoids, other immunosuppressant therapy received within 2 weeks prior to screening;
• Absolute Neutrophil Count (ANC) ≥ 1.0×10 9/L ；platelet count (PLT) ≥30×10 9 /L; Hemoglobin ≥80g/L; There were no obvious abnormalities in liver and kidney function and coagulation function;
• Men and women of childbearing age agree to use contraceptive measures during the study period and within 6 months after the end of the study
Locations
Other Locations
China
Guangzhou First People's Hospital
NOT_YET_RECRUITING
Guangzhou
The First Affiliated Hospital, Zhejiang University School of Medicine
RECRUITING
Hangzhou
Anhui Provincial Hospital
NOT_YET_RECRUITING
Hefei
The 940th hospital of joint logistics support force of Chinese people's liberation army
NOT_YET_RECRUITING
Lanzhou
The First Affiliated Hospital of Guangxi Medical University
NOT_YET_RECRUITING
Nanning
The Affiliated People's Hospital of Ningbo University
NOT_YET_RECRUITING
Ningbo
Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine
NOT_YET_RECRUITING
Shanghai
The Second Hospital of Hebei Medical University
NOT_YET_RECRUITING
Shijiazhuang
Tai'an Central Hospital
NOT_YET_RECRUITING
Taian
Hematology Hospital of the Chinese Academy of Medical Sciences
NOT_YET_RECRUITING
Tianjin
The Second Affiliated Hospital of Xi'an Jiaotong University
NOT_YET_RECRUITING
Xi'an
Xiangyang Central Hospital
NOT_YET_RECRUITING
Xiangyang
Contact Information
Primary
He Huang, PhD
hehuangyu@126.com
13605714822
Time Frame
Start Date:2024-05-07
Estimated Completion Date:2026-04
Participants
Target number of participants:52
Treatments
Experimental: TQ05105 Tablets
TQ05105 Tablets administered twice-daily. 28 days as a treatment cycle.