This is an open, single-arm, multi-center clinical study designed to evaluate the efficacy and safety of TQ05105 tablets combined with TQB3909 tablets in patients with moderate- and high-risk Myelofibrosis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
21
TQ05105 is a Janus kinase 1 (JAK1) and Janus kinase 2 (JAK2) Inhibitor
TQB3909 is an inhibitor targeting B-cell lymphoma-2 (BCL-2) protein.
The Second People's Hospital of Hefei
Hefei, Anhui, China
Hennan Cancer Hospital
Zhengzhou, Henan, China
Xijing Hospital of the Fourth Military Medical University
Xi'an, Shaanxi, China
People's Hospital of Tianjin
Tianjin, Tianjin Municipality, China
Maximal tolerance dose (MTD)
If dose limiting toxicity (DLT) occurs in 2 or more subjects in a given dose group, the dose level in the previous dose group is considered as MTD.
Time frame: Up to 2 years.
Recommended phase II dose (RP2D)
The RP2D is defined as the lower dose level to MTD based on the safety profile
Time frame: Up to 2 years
35% reduction in spleen volume (SVR35) at week 24
The proportion of subjects with a ≥35% reduction in spleen volume 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 once spleen volume reduction ≥ 35% from 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 baseline
Time frame: Up to 120 weeks
Duration of maintenance of at least 35% Reduction in Spleen Volume (DoMSR)
The time between the date when the spleen volume reduction ≥ 35% from baseline occurs for the first time and the date when the spleen volume reduction is \< 35% from baseline.
Time frame: Up to 120 weeks
Percentage change in spleen volume from baseline
Percentage change in spleen volume of subjects from baseline after treatment.
Time frame: Up to 60 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The First Affiliated Hospital Zhejiang University School Of Medicine
Hangzhou, Zhejiang, China
SVR35 at week 60
The proportion of subjects with a ≥35% reduction in spleen volume compared to baseline after treatment at week 60.
Time frame: Up to 60 weeks
Myeloproliferative neoplasm - Symptom Assessment Form - Total Symptom Score (MPN-SAF-TSS)
The proportion of subjects whose total symptom score of MPN-SAF TSS decreased by more than 50% from baseline. MPN-SAF-TSS is a tool for evaluating the disease burden of patients with myeloproliferative neoplasms. Each symptom is scored according to the severity, from asymptomatic (0 points) to the most serious (10 points), a total of 10 levels, the sum of 10 symptom scores is MPN-SAF-TSS score. The higher the score, the more severe the symptoms are.
Time frame: Up to 60 weeks
MPN-SAF-TSS decrease
The time and duration when the MPN-SAF-TSS decreased by ≥50% compared to baseline for the first time.
Time frame: Up to 60 weeks
Progression-free survival (PFS)
The time interval from the first dose 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 date of the first dose to the date of any of the following events, whichever occurs first: (1) the date of the first bone marrow smear showing the original cell ≥20% ;(2) The first peripheral blood smear showed that the original cells ≥ 20% and the absolute value of the original cells ≥1×10\^9/L and lasted for at least 2 weeks; (3) Death caused by any reason.
Time frame: Up to 120 weeks
Overall Survival (OS)
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)
Incidence rate 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: Baseline up to 120 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: Baseline up to 120 weeks