PMF?Post-PV-MF?Post-ET-MF
Conditions
Interventions
1:Jakotinib hydrochloride tablets, 100mg/bid
2:Jakotinib hydrochloride tablets, 200mg/qd
Sponsors
The First Affiliated Hospital, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or older, male or female; 2. Patients diagnosed with PMF according to WHO standard (2016 edition), or patients diagnosed with post-pv-mf or post-et-mf according to iwg-mrt standard;JAK2 mutation or not can be enrolled in the group; 3. Patients with medium-risk -2 or high-risk myelofibrosis were evaluated according to dipss-plus risk grouping criteria;Patients with grade 1 medium-risk myelofibrosis with hepatosplenomegaly and no response to existing treatment and requiring treatment can also be enrolled. 4. The subjects did not have a stem cell transplantation plan in the near future; 5. The expected survival time is more than 24 weeks; 6. ECOG score 0-2; 7. Splenomegaly: palpation of the splenic margin reaching or exceeding at least 5cm below the rib; 8. Peripheral blood protocells 10%; 9. Patients who have not received JAK inhibitor treatment before; 10. ANC 1000/ L, platelet count 100×10^9/L without growth factor, platelet production factor or platelet infusion.Subjects did not receive growth factor infusion within 2 weeks before randomization; 11. 7 days before randomization, the main organs functioned normally, which met the following criteria: ALT and AST 2.5× ULN;DBIL and TBIL 2.0×ULN;Serum creatinine 1.5×ULN, CrCI 50mL/min; 12. Voluntarily sign the informed consent in accordance with the requirements of the ethics committee; 13. Ability to follow study and follow-up procedures.
Exclusion criteria
Exclusion criteria: 1. Any significant clinical or laboratory abnormalities that the investigator considers to affect the safety assessment, such as:a. uncontrolled diabetes (> 250 mg/dL, or 13.9 tendency > / L), b. had high blood pressure and antihypertensive drug treatment under two or unable to descend to the ranges (systolic blood pressure NCI - CTC AE v4.03 standard grade 2 or above); 2. The patients had a history of congestive heart failure, uncontrollable or unstable angina or myocardial infarction, cerebrovascular accident or pulmonary embolism in the first 6 months; 3. Screening of patients who have not fully recovered from surgery within the first 4 weeks; 4. Patients with arrhythmia disease requiring treatment or QTc interval (QTcB) >480ms were screened 5. Screening for bacterial, viral, parasitic or fungal infections requiring treatment with any clinical symptoms; 6. Patients with a history of congenital or acquired hemorrhagic diseases; 7. Patients who had previously undergone splenectomy or who had received radiotherapy of the splenic region in the previous 12 months were screened 8. HIV positive, active hepatitis b virus positive (HBsAg positive, hbv-dna positive or 1000 copies /ml), anti-hcv antibody or hcv-rna positive in screening; 9. Patients suffering from epilepsy or using psychotropic or sedative drugs at the time of screening; 10. Women who are planning to become pregnant or who are pregnant or lactating, and those who were unable to use effective contraceptives throughout the trial;Male patients who do not use condoms during administration and within 2 days (about 5 half-lives) after the last administration; 11. Patients who have had malignant tumors in the past 5 years (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix); 12. Patients with other serious diseases that the researchers believe may affect patient safety or compliance; 13. Suspected allergic to jakatinib hydrochloride or similar drugs; 14. Select those who have participated in the clinical trials of other new drugs or medical devices within the first 3 months; 15. Patients who were treated with any MF drug (e.g., hydroxyl urea), any immunomultigator (e.g., thalidomide), any immunosuppressant, prednisone 10mg/ day or equivalent bioactive glucocorticoid, growth factor (e.g., EPO), or within 6 half-life of the drug within 2 weeks prior to randomization.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effectiveness;safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| DoMSR;PFS;LFS;OS; | — |
Countries
China
Contacts
Public ContactZhu Huanlin
West China Hospital of Sichuan University
Outcome results
None listed