Flonoltinib Maleate for the Treatment of Patients With Intermediate- or High-risk Myelofibrosis Who Are Refractory, Relapsed, or Intolerant to JAK Inhibitors a Single-arm, Open-label, Multicenter Phase IIb Clinical Trial Evaluating Efficacy and Safety
This trial adopts a single arm, open label, multi center clinical trial design, with a planned enrollment of approximately 64 participants in the moderate to high risk MF trial who are refractory, relapsed, or intolerant to JAK inhibitor . Select successful trial participants and allocate flonoltinib maleate tablets based on platelet count levels during the screening period, qd,Oral administration on an empty stomach until the participants meet the withdrawal criteria.
• Age range of 18-80 years old (including threshold), gender not limited;
• Patients diagnosed with primary myelofibrosis (PMF) according to WHO criteria (2016 edition) or patients diagnosed with post polycythemia vera myelofibrosis (PPV-MF) or post thrombocytopenia myelofibrosis (PET-MF) according to IWG-MRT criteria;
• Patients with myelofibrosis assessed as intermediate-2 or high-risk according to the dynamic international prognostic scoring system (DIPSS) prognostic classification criteria;or patients with intermediate-1 myelofibrosis who exhibit hepatosplenomegaly and require treatment;
• MF patients who have received JAK inhibitor treatment in the past and meet the criteria of refractory/recurrent/intolerant;
• Expected survival period greater than 24 weeks;
• ECOG score 0-2 points;
• Splenomegaly: Palpation of the splenic margin reaching or exceeding 5cm below the rib (distance from the intersection of the left clavicle midline and left rib margin to the farthest point of the spleen); Or due to physical reasons (such as obesity), it may not be palpable, but MRI/CT spleen evaluation during screening confirms a volume of \>= 450 cm\^3;
• Peripheral blood and bone marrow blasts \<=10%;
• Within 7 days prior to randomization, ANC \>=1.0 × 10\^9/L, platelet count \>=100 × 10\^9/L, HGB\>60 g/L ;
⁃ Within 7 days prior to randomization, the main organ functions were generally normal, meeting the following criteria: ALT and AST \<= 2.5 × ULN; TBIL\<=2.0×ULN; Serum creatinine \<=1.5 × ULN or serum creatinine clearance rate (Ccr)\>50 mL/min; INR, PT, and APTT \<= 1.5 × ULN;
⁃ Can understand and voluntarily sign an informed consent form..