Clinical trial NCT06300320: A Clinical Trial of TQ05105 Tablets in the Treatment of Chronic Graft-versus-host Disease
Official title: 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).
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Chronic Graft Versus Host Disease
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-03-08
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Currently present or occured other malignancies within 3 years prior to first administration;
* Known or suspected active acute graft versus host disease (aGVHD);
* Presence of infection requiring treatment within 7 days prior to randomization;
* Failed allogeneic hematopoietic stem cell transplantation within 6 months or 2 prior allogeneic hematopoietic stem cell transplants;
* Use of Janus-activated kinase (JAK) inhibitors, Bruton's tyrosine kinase (BTK) inhibitors, or other, chemotherapeutic agents within 2 weeks prior to randomization;
* Has a variety of factors that affect oral medications (e.g., inability to swallow, , intestinal obstruction, etc;
* Those who have a history of psychotropic drug abuse and cannot be abstained from or have a mental disorder;
* Have any severe or uncontrolled serious illness, including but not limited to uncontrolled hypertension, heart disease, hepatitis and epilepsy that require treatment;
* Have any severe or uncontrolled serious illness, including but not limited to，uncontrolled hypertension heart disease, hepatitis and epilepsy that require treatment;
* Those who are allergic to the study drug or its components;
* Participation in other clinical trials or major surgery within 4 weeks prior to the first dose;
* Subjects judged by the investigator to be unsuitable for enrollment;

Primary outcomes:
measure: Objective response rate (ORR) at 24 weeks
timeFrame: Up to 24 weeks
Secondary outcomes:
measure: Best objective response rate (BOR)
timeFrame: Up to 48 weeks
measure: Duration of response (DOR)
timeFrame: Up to 48 weeks
measure: Failure-free survival (FFS)
timeFrame: Up to 48 weeks
measure: Incidence rate of malignancy relapse or recurrence
timeFrame: Up to 48 weeks
measure: Non relapse mortality
timeFrame: At least 48 weeks
measure: Overall Survival (OS)
timeFrame: At least 48 weeks
measure: Adverse event rate
timeFrame: Up to 48 weeks
measure: Severity of adverse events (AEs)
timeFrame: Up to 48 weeks
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Provincial Hospital
state: Anhui
city: Lanzhou
country: China
facility: The 940th hospital of joint logistics support force of Chinese people's liberation army
state: Gansu
city: Guangzhou
country: China
facility: Guangzhou First People's Hospital
state: Guangdong
city: Nanning
country: China
facility: The First Affiliated Hospital of Guangxi Medical University
state: Guangxi
city: Shijiazhuang
country: China
facility: The Second Hospital of Hebei Medical University
state: Hebei
city: Xiangyang
country: China
facility: Xiangyang Central Hospital
state: Hubei
city: Taian
country: China
facility: Tai'an Central Hospital
state: Shangdong
city: Shanghai
country: China
facility: Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine
state: Shanghai
city: Xian
country: China
facility: The Second Affiliated Hospital of Xi'an Jiaotong University
state: Shannxi
city: Tianjin
country: China
facility: Hematology Hospital of the Chinese Academy of Medical Sciences
state: Tianjin
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University School of Medicine
state: Zhejiang
city: Ningbo
country: China
facility: The Affiliated People's Hospital of Ningbo University
state: Zhejiang
Study officials:
References: