This is an open, single-arm, multi-center clinical study designed to evaluate the efficacy of TQ05105 Tablets in patients with intermediate-risk and high-risk myelofibrosis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
TQ05105 Tablets is a Janus kinase 1 (JAK1) and Janus kinase 2 (JAK2) Inhibitor
Anhui Provincial Hospital
Hefei, Anhui, China
The First Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, China
Union Hospital Tongji College Huazhong University of Science And Technology
Wuhan, Hubei, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Spleen volume reduction (SVR35)≥35% from baseline
The proportion of subjects with spleen volume reduction ≥35%from baseline at the end of treatment at week 24.
Time frame: up to 24 weeks
Optimum effective rate
The proportion of subjects with at least one spleen volume measurement of ≥ 35% reduction against the baseline.
Time frame: up to 120 weeks
Onset time of splenic response
The time interval from the first administration to the date when the spleen volume was reduced by ≥ 35 % from the baseline.
Time frame: up to 120 weeks
Duration of maintenance of spleen response (DoMSR) ≥35% reduction
The time between the date when the spleen volume reduction ≥ 35% from baseline for the first time and the date when the spleen volume reduction \< 35% from baseline.
Time frame: up to 120 weeks
Myeloproliferative neoplasm- Symptom Assessment Form- Total Symptom Score (MPN-SAF TSS) : ≥ 50% Reduction from Baseline
The proportion of subjects whose total symptom score on the Myeloproliferative Neoplasia Symptom Assessment Form-Total Symptom Score (MPN-SAF TSS) scale decreased by at least 50% compared to baseline. MPN-SAF-TSS is an effective tool for evaluating the disease burden in patients with myeloproliferative neoplasms. A higher score indicates more severe symptoms in patients. Each symptom is scored according to its severity, ranging from no symptoms (0 points) to the most severe (10 points), with a total of 10 levels. The sum of the scores for these 10 symptoms constitutes the MPN-SAF-TSS score.
Time frame: up to 24 weeks
The total symptom score of MPN-SAF TSS decreased compared with baseline
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The First Hospital of Jilin University
Changchun, Jilin, China
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, China
The total symptom score of MPN-SAF TSS decreased compared with baseline.
Time frame: up to 120 weeks
Progression-free survival (PFS)
The time interval from the first medication to the date of the occurrence of any of the following events, whichever occurs first: (1) Spleen volume increased by≥25% compared with the screening period ; (2) Death caused by any cause.
Time frame: up to 120 weeks
Leukemia free survival (LFS)
The time interval from the first medication to the occurrence of any of the following events, whichever comes first: ① The date on which the first bone marrow smear displays ≥20% blast cells; ② The first instance where the peripheral blood smear displays ≥20% blasts with an absolute blast count of ≥1×10\^9/L, which persists for at least two weeks; ③ Death caused by any reason.
Time frame: up to 120 weeks
Overall Survival (OS)
OS is defined as the time from the first time the subject received treatment to death due to any cause.
Time frame: up to 120 weeks
Incidence of adverse events (AEs)
All adverse medical events that occur after the subject receives the investigational drug may be manifested as symptoms, signs, disease, or laboratory abnormalities, but are not necessarily causally related to the investigational drug, evaluated according to the Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0).
Time frame: baseline up to 120 weeks
Severity of AEs
All adverse medical events that occur after the subject receives the investigational drug may be manifested as symptoms, signs, disease, or laboratory abnormalities, but are not necessarily causally related to the investigational drug, evaluated according to the CTCAE v5.0.
Time frame: baseline up to 120 weeks