NCT07317700
Recruiting
Phase 3
A Randomized, Open-label, Positive-controlled, Parallel-grouped, Multicenter Phase III Clinical Trial on the Efficacy and Safety of Flonoltinib Maleate Tablets in Patients With Intermediate- or High-risk Myelofibrosis
Chengdu Zenitar Biomedical Technology Co., Ltd2 sites in 1 country105 target enrollmentStarted: February 13, 2026Last updated:
Overview
- Phase
- Phase 3
- Status
- Recruiting
- Enrollment
- 105
- Locations
- 2
- Primary Endpoint
- Percentage of subjects with >=35% reduction in spleen volume from baseline
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion 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;
- •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;
- •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.
Exclusion Criteria
- •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;
- •Individuals with impaired cardiac function (those with ejection fraction\<45% detected by echocardiography, congenital ventricular arrhythmia, QTcF\>450 ms on electrocardiogram (males), QTcF\>470 ms on electrocardiogram (females), or those with arrhythmia requiring treatment at the time of screening);
- •Patients with congenital or acquired bleeding disorders or unstable thrombotic diseases requiring anticoagulant therapy;
- •Any active infection requiring systemic treatment (oral, intravenous, subcutaneous, intramuscular, etc.) within the first 14 days of randomization;
- •Active infection of hepatitis B virus (HBV) or hepatitis C virus (HCV), except for the following patients: a) HBV infection: patients who are positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and undergo peripheral blood HBV-DNA testing, with the lower limit of HBV-DNA detection value (i.e. the upper limit of normal value in the laboratory of each research center) can be enrolled; If the baseline HBsAg is positive, continuous antiviral treatment is required after enrollment, and HBV-DNA testing should be conducted every 12 weeks and at EOT visits; b) Patients who are positive for HCV serology but negative for HCV-RNA can be included in the study;
- •Patients who are positive for human immunodeficiency virus antibodies (HIV Ab) or anti Treponema pallidum antibodies (TP Ab) (Treponema pallidum antibodies positive);
- •Patients with epilepsy or those taking psychotropic or sedative drugs during screening;
Arms & Interventions
Experimental group
Experimental
Flonoltinib Maleate Tablets 75mg, taken orally, qd， Administer on an empty stomach
Intervention: Flonoltinib 75mg (Drug)
control group
Active Comparator
he dosage of Ruxolitinib Phosphate Tablets should be administered orally according to the instructions, bid， Administer on an empty stomach
Intervention: Ruxolitinib Phosphate (Drug)
Outcomes
Primary Outcomes
Percentage of subjects with >=35% reduction in spleen volume from baseline
Time Frame: Week 24
Secondary Outcomes
- Spleen response time: The time when the spleen volume is first observed to decrease by >=35% from baseline(Week 12,week 24)
- Overall survival period(Week 2,week 4,week 8,week 12,week 24)
- MPN-SAF TSS Total Symptom Score and Baseline Comparison Decrease(Week 2,week 4,week 8,week 12,week 24)
Investigators
Study Sites (2)
Loading locations...
Similar Trials
Not yet recruiting
Not Applicable
A Study on the Bioavailability of SHR-1819 Injection Administered Subcutaneously Using Different Injection Devices in Healthy SubjectsNCT07264335Guangdong Hengrui Pharmaceutical Co., Ltd160
Completed
Not Applicable
Efficacy and Safety of THDB0206 Compared to Insulin Lispro Injection in Participants With Type 1 DiabetesNCT07282054Tonghua Dongbao Pharmaceutical Co.,Ltd550
Recruiting
Not Applicable
A Study Comparing the Efficacy and Safety of HRS9531 Injection With Semaglutide Injection in Subjects With ObesityNCT07285902Fujian Shengdi Pharmaceutical Co., Ltd.750
Recruiting
Phase 1
A Trial of LBL-024 Monotherapy or Combination Drug in Patients With Triple Negative Breast CancerNCT07281976Nanjing Leads Biolabs Co.,Ltd220
Recruiting
Phase 3
A Phase III Study Comparing HRS-4357 With Novel Androgen Receptor Pathway Inhibitors in Patients With Progressive, PSMA-Positive Metastatic Castration-Resistant Prostate CancerNCT07311694Jiangsu HengRui Medicine Co., Ltd.370