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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Flonoltinib Maleate Tablets 75mg, taken orally, qd, Administer on an empty stomach |
|
| control group | Active Comparator | he dosage of Ruxolitinib Phosphate Tablets should be administered orally according to the instructions, bid, Administer on an empty stomach |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flonoltinib 75mg | Drug | Flonoltinib 75mg,qd |
| |
| Ruxolitinib Phosphate |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects with >=35% reduction in spleen volume from baseline | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Spleen response time: The time when the spleen volume is first observed to decrease by >=35% from baseline | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wang Fangmei | Contact | 13808086495 | fangmei.wang@zenitar.cn | |
| Sun Liangkun | Contact | 15885742617 | liangkunsun@zenitar.cn |
| Name | Affiliation | Role |
|---|---|---|
| Xiao Zhijian, Doctor | Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (IHCAMS) | Principal Investigator |
| Niu Ting, Doctor | West China Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital Sichuan University | Recruiting | Chengdu | Sichuan | China |
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| ID | Term |
|---|---|
| C540383 | ruxolitinib |
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| Drug |
Ruxolitinib Phosphate ,control group |
|
| 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 | Week 2,week 4,week 8,week 12,week 24 |
| Miao Jia, Doctor | West China Hospital | Principal Investigator |
| Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (IHCAMS) | Recruiting | Tianjin | Tianjin Municipality | 300052 | China |
|