jaktinib versus hydroxycarbamide in subjects with intermediate-2 or high-risk myelofibrosis

Conditions: Myelofibrosis

Summary: this study is to determine the efficacy of jaktinib versus hydroxycarbamid in participants with intermediate-2 or high-risk myelofibrosis


Eligibility criteria:
inclusion criteria: * age ≥ 18 years old,either male or female; * subjects diagnosed with a pmf according to world health organiztion criteria (2016 edition), or patients diagnosed with a post-pv-mf or post-ef-mf according to international working group for myeloproliferative neoplasms research and treatment criteria; * high risk or intermediate-2 risk as defined by the dynamic international prognostic scoring system (dipss) for primary myelofibrosis; * subjects have no plan for stem cell transplantation in the near future; * life expectancy of \> 24 weeks; * ecog performance status of 0-1; * palpable splenomegaly at least 5 cm below left costal margin; * peripheral blood blast count ≤ 10%; * subjects who have not yet received treatment with a jak inhibitor, or subjects who have been treated with jak inhibitors for ≤10 days; * subjects have not received growth factor, thrombopoietin mimetics or platelet transfusion(s) within 2 weeks before the randomization; anc≥ 1.0×10\^9/l, platelet count ≥ 100×10\^9/l within 2 days before the randomization; * normal functions in major organs within 7 days before the randomization, fulfilling the following criteria: alt and ast ≤ 2.5×uln; dbil and tbil ≤ 2.0×uln; serum creatinine ≤ 1.5×uln; * if the subject is receiving any anti-myelofibrosis treatment (except for jak inhibitors and hydroxyurea) at screening, the dosing regimen must remain unchanged for at least 2 weeks before screening. if the investigator judges that there is no need to continue to use, stop the use of thalidomide, androgens and prednisone\> 10 mg during screening. the drugs used to improve anemia should be stopped for at least 6 half-lives or 2 weeks before randomization(whichever is the longer); * if the subject is receiving hydroxycarbamide treatment at screening, the drug must be discontinued ≥ 2 weeks before the randomization; * meet the requirements of the ethics committee and willing to sign the informed consent form; * ability to comply with trial and follow-up procedures. exclusion criteria: * subjects with any significant clinical and laboratory abnormalities which may affect the safety evaluation, such as uncontrolled diabetes, uncontrolled hypertension after taking two or more hypotensive drugs, peripheral neuropathy; * subjects with congestive heart failure, uncontrolled or unstable angina or myocardial infarction, cerebrovascular accident, or pulmonary embolism within 24 weeks prior to screening; * subjects who have not fully recovered from surgical operation within 4 weeks prior to screening; * subjects suffering from arrhythmia and requiring treatment at screening; * subjects with clinical symptoms of active bacterial, viral, parasitic or fungal infections requiring treatment at screening; * chest x-rays suggest an active lung infection at screening; * subjects who had active tuberculosis infection within 48 weeks before screening;γ-interferon release test suggests latent tuberculosis infection at screening; * subjects who had undergone splenectomy, or received radiotherapy to the spleen within 48 weeks before screening; * subjects with known human immunodeficiency virus (hiv), known active infectious hepatitis b (hepb), and/or known active infectious hepatitis c (hepc); * subjects with epilepsy or patients who have received psychotropic drug or sedatives during screening; * female subjects who are pregnant, currently breastfeeding, planning to become pregnant;subjects who are unable to adopt effective contraceptive methods during the study; male subjects who did not use condoms during the dosing period and within 2 days after the last dose * subjects who had experienced malignant tumors within the past 5 years (except for adequately treated local basal cell carcinoma of the skin and cervical carcinoma in situ that have been cured); * subjects who are unsuitable to the trial in combination with other serious diseases, as identified by the investigator; * subjects with suspected allergies to jaktinib or its excipient; * subjects who have participated in another clinical trial of a new drug or medical instrument within 12 weeks before screening.