About this trial
This trial adopts an open, randomized, parallel controlled, multicenter clinical trial design planning to enroll patients with polycythemia vera who are resistant/intolerant to hydroxyurea or interferon。The study divided into two stages: dose exploration stage: three dose groups are tentatively set, with three subjects in each group, totaling nine subjects in each group; Dose extension stage: Based on the safety, efficacy, and pharmacokinetic results of the comprehensive dose exploration stage, 2-3 dose groups are planned to be selected for dose extension trials.
Eligibility criteria
Qualifiers
Age >= 18 years old and gender not limited when signing the informed consent form;
Diagnosed as PV according to WHO standards (2016 edition), and resistant/intolerant to hydroxyurea or interferon treatment (refer to attachments 1 and 2);
When screening, the peripheral blood primitive cells are 0%;
Disqualifiers
Individuals with allergies or suspected allergies to the test drug and its excipients;
The toxic reactions of previous anti-cancer treatments have not recovered to grade 1 or below (excluding hair loss, blood routine and blood biochemical indicators refer to inclusion criteria 4 and 5), or have not fully recovered from previous surgeries (having undergone major surgery within 4 weeks);
In addition to PV, any other myeloproliferative neoplasms (MPN), including post polycythemia vera myelofibrosis (PPV-MF), may also be present;
Any active infections that require systemic treatment (oral, intravenous, subcutaneous, intramuscular, etc.) during screening;
Trial design
Treatments tested in this trial
- Flonoltinib 75mg
- Flonoltinib 100mg
- Flonoltinib 125mg
- Extended Phase Dose Group