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Age greater than or equal to 18 years old ,male or female |
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Patients diagnosed with Primary Myelofibrosis according to WHO standard (2016 version), or patients diagnosed with Post-Polycythemia Vera Myelofibrosis or Post-Essential Thrombocythemia Myelofibrosis according to International Working Group Myeloproliferative Neoplasms Research and Treatment(IWG-MRT) standard. Both Janus Kinase 2(JAK2)mutation and JAK2 wild can be enrolled |
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According to Dynamic International Prognostic Scoring System plus(DIPSS-plus) risk grouping criteria, patients with medium-risk-2 or high-risk myelofibrosis were assessed,Patients with grade 1 medium-risk myelofibrosis with hepatosplenomegaly and no response to existing treatment and requiring treatment can also be enrolled |
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Patients who have received or are receiving Ruxolitinib,andRuxolitinib treatment time is not less than 28 days;Red blood cell transfusion is still needed during treatment with Ruxolitinibor Ruxolitinib dose (including starting dose and adjusted dose)20mg bidAnd must meet at least one of the followingLevel 3 or higher platelet count reduction or Level 3 or higher anemia or Level 3 or higher hematoma/bleeding |
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a life expectancy > 24 weeks |
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Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 |
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Splenomegaly: palpation of the splenic margin to or above the subcostal at least 5cm |
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Within 14 days before enrollmentThe Laboratory indicators meet the following criteria |
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Absolute neutrophil countANC > 0.75 x 10^9/Lblood platelet count> 30 x 10^9/L,And no colony stimulating factor was used within 7 days before screening |
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Peripheral blood blast < 10% |
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ASTALT3xULNPatients with severe extramedullary hematopoiesis or who have received iron therapy within 60 days prior to screening and thus have liver function damage,ASTALT5xULN |
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Direct bilirubin2.0ULN |
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Creatinine clearance45mL/min |
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Meet the requirements of the Ethics Committee, voluntarily sign an informed consent form |
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Ability to follow research and follow-up procedures |
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Any significant clinical or laboratory abnormalities that the investigator considers to affect safety assessment, such as: a. uncontrolled diabetes (> 250 mg/dL, or 13.9>mmol/L), b. had high blood pressure and antihypertensive drug treatment under two or unable to descend to the ranges (systolic blood pressure < 160 mmHg, diastolic pressure < 100 mmHg), c. peripheral neuropathy (NCI - CTC AE v5.0 standard grade 2 or above), etc
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The patients who had a history of congestive heart failure(NCI - CTC AE v5.0 standard grade 3or above), uncontrollable or unstable angina or myocardial infarction, cerebrovascular accident or pulmonary embolism in the first 6 months
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Screening of patients who have surgery within the first 4 weeks
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Screening for patients with arrhythmia requiring treatment or QTc interval (QTcB) >480ms
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Screening for bacterial, viral, parasitic or fungal infections that require treatment
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Patients which have with a history of congenital or acquired hemorrhagic diseases;(Note:With the exception of hematoma which caused by Ruxolitinib)
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Splenectomy patients or in the group carried out within three months before the spleen radiation treatment (including internal radiation and external radiation)
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Screening HIV, HBV DNA positive or higher than the normal reference range, or HCV RNA positive for HCV antibody
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Women who are planning to become pregnant or who are pregnant or breast- feeding, as well as those who were unable to use effective contraceptives throughout the trial;Male patients who do not use condoms during the administration and within 2 days (approximately 5 half-lives) after the last administration
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Patients who have suffered from malignant tumors (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix) in the past 5 years; Combined with other serious diseases, the researchers believe that patients' safety or compliance may be affected
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With other serious diseases, the researchers think that may affect patient safety or compliance
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The patients who had used the Jakatinib hydrochloride
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Patients who have participated in the clinical trials of other new drugs or medical devices within the first 1 months
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The patients who used the Hematopoietic growth factors within 14 days before Into the group (granulocyte growth factors, or platelet hormone)
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Patients who cannot cooperate with or cannot perform MRI or CT scans
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Patients with refractory or recurrent myelofibrosis
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refractory of myelofibrosis:After at least 28 days of adequate administration
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of JAK inhibitors, the spleen palpation was less than 15% smaller than before
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administration.Or at least 3 months later, the spleen volume on MRI/CT
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decreased by <10% compared with that before the administration
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Recurrence of myelofibrosis: after at least 3 months of taking adequate amount
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of JAK inhibitor, the spleen was enlarged again after shrinking compared with
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that before taking the drug, and compared with the minimum value during taking
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the drug, the spleen volume increased 10% on MRI/CT examination or 30% on
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spleen palpation
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\. Any treatment MF medication (eg hydroxyurea,except ruxolitinib ), any
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immunomodulation used within 2 weeks prior to enrollment Agent (such as
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thalidomide), any immunosuppressant, glucocorticoids 10 mg/day of prednisone
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or equivalent biological strength, or patients within 6 half-life of the drug
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over time Prevail;Patients who had received rucotinib within 1 week prior to
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enrolling
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