This trial adopts a multicenter, open label, positive drug parallel controlled clinical trial design, with a planned enrollment of approximately 105 participants in the MF trial. Successful trial participants were selected and assigned to either the experimental group or the control group in a 2:1 stratified manner, with the stratification factor being the Dynamic International Prognostic Scoring System (DIPSS) prognostic grading criteria. Continuously take the test drug/control drug until it meets the withdrawal criteria.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
105
Flonoltinib 75mg,qd
Ruxolitinib Phosphate ,control group
West China Hospital Sichuan University
Chengdu, Sichuan, China
RECRUITINGInstitute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (IHCAMS)
Tianjin, Tianjin Municipality, China
RECRUITINGPercentage of subjects with >=35% reduction in spleen volume from baseline
Time frame: Week 24
Spleen response time: The time when the spleen volume is first observed to decrease by >=35% from baseline
Time frame: Week 12,week 24
MPN-SAF TSS Total Symptom Score and Baseline Comparison Decrease
The MPN-SAF-TSS is used to assess the symptom burden of patients with myeloproliferative neoplasms. The questionnaire also reflects the quality of life of patients to a certain extent. During the diagnosis and treatment process, the MPN-10 questionnaire includes 10 sub symptoms (fatigue, early satiety, abdominal discomfort, poor activity, lack of concentration, night sweats, skin itching, bone pain, fever, and weight loss). Each item is graded from 0 (none) to 10 (heaviest), with a total score of 0-100 points. The higher the total score, the heavier the symptom burden.
Time frame: Week 2,week 4,week 8,week 12,week 24
Overall survival period
The time interval between the first use of medication and death caused by any reason
Time frame: Week 2,week 4,week 8,week 12,week 24
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