MFPhase 3NCT07317700
A Clinical Trial of Flonoltinib Maleate for Intermediate or High-Risk Myelofibrosis
A Phase 3 study testing Flonoltinib 75mg and Ruxolitinib Phosphate in people with MF, run by Chengdu Zenitar Biomedical Technology Co., Ltd at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- MF
- What is being tested?
- Flonoltinib 75mg and Ruxolitinib Phosphate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 2 sitesChina
- Study dates
- 13 Feb 2026to 30 Mar 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- Splenomegaly: Palpation of the splenic margin reaching or exceeding 5cm below the rib ; 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.
Who cannot join
- 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;
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- 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;
- Pregnant or lactating female patients, female/male patients with fertility who refuse to use contraceptive measures during the trial period and within 6 months after the trial ends;
- Patients who have suffered from other malignant tumors within the past 5 years before the first administration (excluding cured carcinoma in situ and basal cell carcinoma of the skin);
- Patients with combined swallowing difficulties;
- Patients who participated in clinical trials of other new drugs or medical devices within the first month of randomization and took the study drug or used the study device;
- Researchers believe that there are other factors that are not suitable for participating in the experiment.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
West China Hospital Sichuan University
Chengdu, Sichuan
Min Hou, +86-28-85422654, huaxilunli@163.com
- Recruiting
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (IHCAMS)
Tianjin, Tianjin Municipality, 300052
Qirou Wang, 86+22-23909095, ec@ihcams.ac.cn
About this study
Official title: 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
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.
- Conditions
- MF
- Being tested
- Flonoltinib 75mg, Ruxolitinib Phosphate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flonoltinib 75mgDrug
Flonoltinib 75mg，qd
Ruxolitinib PhosphateDrug
Ruxolitinib Phosphate ,control group
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Flonoltinib Maleate Tablets 75mg, taken orally, qd Receives: Drug: Flonoltinib 75mg |
| control group | Active comparator | The dosage of Ruxolitinib Phosphate Tablets is based on baseline PLT level according to the label, taken orally, bid Receives: Drug: Ruxolitinib Phosphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects with >=35% reduction in spleen volume from baseline
Measured: Week 24
Secondary outcomes (3)
Spleen response time: The time when the spleen volume is first observed to decrease by >=35% from baseline
Measured: Week 12,week 24
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.
Measured: Week 2,week 4,week 8,week 12,week 24
Overall survival period
The time interval between the first use of medication and death caused by any reason
Measured: Week 2,week 4,week 8,week 12,week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start13 Feb 2026
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MFStudies of the same condition, open and under way.
- More trials run by Chengdu Zenitar Biomedical Technology Co., LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chengdu Zenitar Biomedical Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xiao Zhijian, Doctor, Principal investigator, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (IHCAMS)Niu Ting, Doctor, Principal investigator, West China HospitalMiao Jia, Doctor, Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07317700
- Sponsor's protocol ID
- FMF-03
- Status last verified
- Mar 2026
- First submitted
- 19 Dec 2025
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07317700
- Acronym / sponsor ID
- FMF-03
- Conditions
- MF
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Chengdu Zenitar Biomedical Technology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 13 Feb 2026 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Mar 2028 (estimated)
- First posted
- 5 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Flonoltinib 75mgFlonoltinib Maleate Tablets 75mg, taken orally, qd |
| control group | Active comparator | Drug: Ruxolitinib PhosphateThe dosage of Ruxolitinib Phosphate Tablets is based on baseline PLT level according to the label, taken orally, bid |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
- Splenomegaly: Palpation of the splenic margin reaching or exceeding 5cm below the rib ; 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;
Key exclusion criteria (15 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flonoltinib 75mgFlonoltinib 75mg，qd | Drug | Experimental group |
| Ruxolitinib PhosphateRuxolitinib Phosphate ,control group | Drug | control group |
Primary outcome
Percentage of subjects with >=35% reduction in spleen volume from baseline
Time frame: Week 24
3 secondary outcomes
Spleen response time: The time when the spleen volume is first observed to decrease by >=35% from baseline
Time frame: Week 12,week 24
MPN-SAF TSS Total Symptom Score and Baseline Comparison Decrease
Time frame: Week 2,week 4,week 8,week 12,week 24
Overall survival period
Time frame: Week 2,week 4,week 8,week 12,week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
Related trials for MF
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RecruitingPhase 1
A Phase 1 Study of PRT12396 in Participants With Select Myeloproliferative Neoplasms
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Active, not recruitingPhase 2
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Selinexor and Pacritinib in JAK Inhibitor-naïve MF Patients With Cytopenias
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiao Zhijian, Doctor principal investigator
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (IHCAMS)
Niu Ting, Doctor principal investigator
West China Hospital
Miao Jia, Doctor principal investigator
West China Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Flonoltinib 75mg and Ruxolitinib Phosphate in people with MF, run by Chengdu Zenitar Biomedical Technology Co., Ltd at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wang Fangmei (13808086495, fangmei.wang@zenitar.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of subjects with >=35% reduction in spleen volume from baseline (time frame: Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.