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A Clinical Trial of Flonoltinib Maleate for Intermediate or High-Risk Myelofibrosis

ConditionMF
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorChengdu Zenitar Biomedical Technology Co., Ltd

About this trial

This trial adopts a multicenter, open label, positive drug parallel controlled clinical trial design, with a planned enrollment of approximately 105 participants in the MF trial. Successful trial participants were selected and assigned to either the experimental group or the control group in a 2:1 stratified manner, with the stratification factor being the Dynamic International Prognostic Scoring System (DIPSS) prognostic grading criteria. Continuously take the test drug/control drug until it meets the withdrawal criteria.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age range of 18-80 years old , 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;

Expected survival period greater than 24 weeks;

ECOG score 0-2 points;

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;

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

Design model

Parallel

Treatments tested in this trial

  • Flonoltinib 75mg

    Drug

    Flonoltinib 75mg，qd

  • Ruxolitinib Phosphate

    Drug

    Ruxolitinib Phosphate ,control group

Treatment groups

105 Participants
are divided into 2 treatment groups
Group A: Experimental groupExperimental treatment 1 intervention
Group B: control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percentage of subjects with >=35% reduction in spleen volume from baseline

Time frame
Week 24

Secondary outcomes

1

Spleen response time: The time when the spleen volume is first observed to decrease by >=35% from baseline

Time frame
Week 12,week 24
2

MPN-SAF TSS Total Symptom Score and Baseline Comparison Decrease

The MPN-SAF-TSS is used to assess the symptom burden of patients with myeloproliferative neoplasms. The questionnaire also reflects the quality of life of patients to a certain extent. During the diagnosis and treatment process, the MPN-10 questionnaire includes 10 sub symptoms (fatigue, early satiety, abdominal discomfort, poor activity, lack of concentration, night sweats, skin itching, bone pain, fever, and weight loss). Each item is graded from 0 (none) to 10 (heaviest), with a total score of 0-100 points. The higher the total score, the heavier the symptom burden.

Time frame
Week 2,week 4,week 8,week 12,week 24
3

Overall survival period

The time interval between the first use of medication and death caused by any reason

Time frame
Week 2,week 4,week 8,week 12,week 24

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chengdu Zenitar Biomedical Technology Co., Ltd

Lead sponsor

Source ClinicalTrials.gov
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