A Clinical Trial of Flonoltinib Maleate Tablets in the Treatment of JAK Inhibitor Refractory/Relapsed/Intolerant Patients With Medium to High Risk Myelofibrosis

ConditionMF
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorChengdu Zenitar Biomedical Technology Co., Ltd

About this trial

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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

The toxic reactions of previous anti-cancer treatments have not recovered to grade 1 or below (excluding hair loss), or have not fully recovered from previous surgeries(such as undergoing major surgery within 4 weeks);

Allergy to experimental drugs and their excipients;

For any significant clinical and laboratory abnormalities, the researchers believe that they affect the safety evaluators, such as: a. uncontrollable diabetes - fasting blood glucose>250 mg/dL (13.9 mmol/L), b. hypertension and cannot be reduced to the following range after treatment with two or more antihypertensive drugs (systolic blood pressure<160 mmHg, diastolic blood pressure<100 mmHg), c. peripheral neuropathy;

Patients with a history of congestive heart failure (NYHA grade III or above), unstable angina or myocardial infarction, cerebrovascular accidents or thromboembolism within the first 6 months of screening;

Trial design

Treatments tested in this trial

  • Flonoltinib Maleate

Treatment groups

64 Participants
are divided into 1 treatment group