Primary Myelofibrosis (PMF) or Post-polycythemia Vera or Post- essential Thrombocythemia Myelofibrosis (Post-PV/ET MF)
Conditions
Interventions
1:Jaktinib hydrochloride tablets,100mg bid
2:Hydroxycarbamide tablets 0.5g bid
Sponsors
The First Affiliated Hospital of Medical School of Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >=18 years old male or female; 2. Subjects diagnosed with a PMF according to World Health Organization 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; 3. High risk or intermediate-2 risk as defined by the Dynamic International Prognostic Scoring System (DIPSS) for Primary Myelofibrosis; 4. Subjects have no plan for stem cell transplantation in the near future; 5. Life expectancy of > 24 weeks; 6. ECOG performance status of 0-1; 7. Palpable splenomegaly at least 5 cm below left costal margin; 8. Peripheral blood blast count =1.0x10^9/L, platelet count >=100x10^9/L within 2 days before the randomization; 11. Normal functions in major organs within 7 days before the randomization, fulfilling the following criteria: ALT and AST 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); 13. If the subject is receiving Hydroxycarbamide treatment at screening, the drug must be discontinued = 2 weeks before the randomization; 14. Meet the requirements of the ethics committee and willing to sign the informed consent form; 15. Ability to comply with trial and follow-up procedures.
Exclusion criteria
Exclusion criteria: 1. 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; 2. Subjects with congestive heart failure, uncontrolled or unstable angina or myocardial infarction, cerebrovascular accident, or pulmonary embolism within 24 weeks prior to screening; 3. Subjects who have not fully recovered from surgical operation within 4 weeks prior to screening; 4. Subjects suffering from arrhythmia and requiring treatment at screening; 5. Subjects with clinical symptoms of active bacterial, viral, parasitic or fungal infections requiring treatment at screening; 6. Chest X-rays suggest an active lung infection at screening; 7. Subjects who had active tuberculosis infection within 48 weeks before screening;?-Interferon release test suggests latent tuberculosis infection at screening; 8. Subjects who had undergone splenectomy, or received radiotherapy to the spleen within 48 weeks before screening; 9. Subjects with known human immunodeficiency virus (HIV), known active infectious Hepatitis B (HepB), and/or known active infectious Hepatitis C (HepC); 10. Subjects with epilepsy or patients who have received psychotropic drug or sedatives during screening; 11. 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; 12. 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); 13. Subjects who are unsuitable to the trial in combination with other serious diseases, as identified by the investigator; 14. Subjects with suspected allergies to Jaktinib or its excipient; 15. Subjects who have participated in another clinical trial of a new drug or medical instrument within 12 weeks before screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Spleen Volume Response rate at Week 24; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate (complete remission + partial remission);Spleen Response;Anemia Response;Response rate of MF-related symptoms; | — |
Countries
China
Contacts
Public ContactHewen Yin
Suzhou Zelgen Biopharmaceuticals Co., Ltd.
Outcome results
None listed