Actively Recruiting
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).
Led by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Updated on 2025-02-11
52
Participants Needed
12
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial is investigating the use of TQ05105 Tablets in adults aged 18 to 70 with moderate to severe chronic graft-versus-host disease (cGVHD) following allogeneic hematopoietic stem cell transplantation. The study aims to evaluate the efficacy and safety of this oral medication, which targets inflammatory and fibrotic processes involved in cGVHD. The trial is open-label and multicenter, sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd., and conducted as a Phase II clinical study. Participants receive TQ05105 Tablets twice daily in 28-day treatment cycles. The study measures responses up to 48 weeks, including treatment effectiveness and safety outcomes. The primary outcome is the objective response rate at 24 weeks. Secondary outcomes include duration of response, survival rates, incidence of relapse, and adverse events. The study does not involve placebo or blinding. During their participation, patients will be monitored regularly with assessments to track their response to treatment, side effects, and overall health status. Evaluations include laboratory tests and clinical examinations related to cGVHD severity and treatment impact. The total participation period extends up to 48 weeks or more, with ongoing observation for safety and survival measures. Participants will follow a stable medication regimen and adhere to contraceptive measures if applicable.
CONDITIONS
Brief Title
A Clinical Trial of TQ05105 Tablets in the Treatment of Chronic Graft-versus-host Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary and signed informed consent with good compliance
- Age between 18 and 70 years old
- Karnofsky Performance Scale (KPS) score of 60 points or higher
- Life expectancy of 6 months or more
- Received allogeneic hematopoietic stem cell transplantation
- Diagnosed with moderate-to-severe chronic graft-versus-host disease (cGVHD)
- Previously received systemic therapies for cGVHD
- Stable dose of glucocorticoids or other immunosuppressants within 2 weeks before screening
- Absolute Neutrophil Count (ANC) of at least 1.0 x 10^9/L
- Platelet count of at least 30 x 10^9 /L
- Hemoglobin level of at least 80 g/L
- No significant liver, kidney, or coagulation abnormalities
- Men and women of childbearing age agree to use contraception during the study and for 6 months after
You will not qualify if you...
- Presence of current or past other malignancies within 3 years before first dose
- Known or suspected active acute graft-versus-host disease (aGVHD)
- Infection requiring treatment within 7 days before randomization
- Failure of allogeneic hematopoietic stem cell transplantation within 6 months or having had 2 prior transplants
- Use of JAK inhibitors, BTK inhibitors, or chemotherapeutic agents within 2 weeks before randomization
- Conditions affecting oral medication intake, such as inability to swallow or intestinal obstruction
- History of psychotropic drug abuse or unmanaged mental disorders
- Severe or uncontrolled illnesses including hypertension, heart disease, hepatitis, or epilepsy requiring treatment
- Allergy to the study drug or its components
- Participation in other clinical trials or major surgery within 4 weeks before first dose
- Investigator judgment of unsuitability for enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 24 weeks
Participants receive TQ05105 tablets twice daily in 28-day treatment cycles to manage chronic graft-versus-host disease.
Multiple visits during treatment cycles
Trial Site Locations
Total: 12 locations
1
Anhui Provincial Hospital
Hefei, Anhui, China, 230001
Not Yet Recruiting
2
The 940th hospital of joint logistics support force of Chinese people's liberation army
Lanzhou, Gansu, China, 730050
Not Yet Recruiting
3
Guangzhou First People's Hospital
Guangzhou, Guangdong, China, 510180
Not Yet Recruiting
4
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China, 530021
Not Yet Recruiting
5
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050000
Not Yet Recruiting
6
Xiangyang Central Hospital
Xiangyang, Hubei, China, 441021
Not Yet Recruiting
7
Tai'an Central Hospital
Taian, Shangdong, China
Not Yet Recruiting
8
Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025
Not Yet Recruiting
9
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shannxi, China, 710299
Not Yet Recruiting
10
Hematology Hospital of the Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China, 300020
Not Yet Recruiting
11
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
12
The Affiliated People's Hospital of Ningbo University
Ningbo, Zhejiang, China, 315040
Not Yet Recruiting
Research Team
H
He Huang, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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