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MF,PMF,PPV-MF,PET-MFPhase 2NCT06457425

A Phase II Clinical Trial of Flonoltinib Maleate Tablet in Intermediate-High Risk Myelofibrosis

A Phase 2 study testing Flonoltinib 50mg, Flonoltinib 100mg and Ruxolitinib in people with MF,PMF,PPV-MF,PET-MF, run by Chengdu Zenitar Biomedical Technology Co., Ltd at 2 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This trial adopts a multicenter, open-label, positive drug parallel control clinical trial design, planning to enroll approximately 75 MF participants. Eligible participants will be stratified and assigned in a 1:1:1 ratio to the low-dose flonoltinib maleate tablet group, high-dose flonoltinib maleate tablet group, or… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
MF,PMF,PPV-MF,PET-MF
What is being tested?
Flonoltinib 50mg, Flonoltinib 100mg and Ruxolitinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
2 sitesChina
Study dates
6 May 2024to 12 May 2027
Phase
Phase 2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years, no gender restrictions;
  • Diagnosed with primary myelofibrosis (PMF) according to WHO criteria (2016 edition) or post-polycythemia vera myelofibrosis (PPV-MF) or post-essential thrombocythemia myelofibrosis (PET-MF) according to IWG-MRT criteria;
  • Evaluated as intermediate-2 or high-risk myelofibrosis according to the Dynamic International Prognostic Scoring System (DIPSS) risk classification;
  • Expected survival ≥ 24 weeks;
  • ECOG score of 0-2;
  • Splenomegaly: palpable spleen edge reaching or exceeding 5 cm below the costal margin (distance from the intersection of the left midclavicular line and the left costal margin to the farthest point of the spleen); or not palpable due to body habitus (obesity) but confirmed by magnetic resonance imaging (MRI ) (or CT scan if necessary) at screening with spleen volume ≥ 450 cm³;
  • Blasts in peripheral blood and bone marrow ≤ 10%; 8) Within 7 days before the first dose, absolute absolute neutrophil count (ANC )≥ 1.0×10^9/L, platelet count ≥ 50×10^9/L, hemoglobin (HGB )> 60 g/L (participants should not have received growth factors, colony-stimulating factors, thrombopoietic agents, or platelet transfusions within 2 weeks before the baseline assessment prior to the first dose); 9) Major organ function basically normal within 7 days before the first dose; 10) Able to understand and voluntarily sign the informed consent form.

Who cannot join

  • Previous anticancer treatment-related toxic reactions have not recovered to grade 1 or below (excluding alopecia and conditions specified in inclusion criteria 8 and 9), or have not fully recovered from previous surgery (major surgery within 4 weeks);
  • Hypersensitivity, allergic to the investigational drug or its excipients;
  • Previous intolerance or resistance to ruxolitinib;
  • Use of JAK inhibitors within 4 weeks before the first dose;
  • Any significant clinical and laboratory abnormalities that, in the investigator's opinion, affect safety evaluation;
  • History of congestive heart failure, unstable angina, myocardial infarction, cerebrovascular accident (excluding lacunar infarction), or pulmonary embolism within 6 months prior to screening;
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  • Impaired cardiac function or arrhythmic disease requiring treatment at screening;
  • Any active infection requiring intravenous antibiotic treatment at screening;
  • Active tuberculosis infection within 48 weeks prior to screening or latent tuberculosis infection indicated by tuberculosis-related tests during the screening period;
  • Patients who have undergone splenectomy or received radiation therapy to the spleen area within 12 months before the first dose;
  • Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, except for: a) HBV infection: Patients with positive hepatitis B surface antigen (HbsAg) or hepatitis B core antibody (HbcAb) with undetectable peripheral blood HBV-DNA (below the detection limit of the testing laboratory) can be enrolled; they must continue antiviral therapy and have HBV-DNA testing every 12 weeks and at the end of treatment (EOT); b) HCV seropositive patients with negative HCV RNA can be enrolled.
  • Positive for human immunodeficiency virus antibody (HIV-Ab) or Treponema pallidum antibody (TP-Ab) (patients with positive Treponema pallidum antibody can have a titer test, and the investigator will determine eligibility based on comprehensive judgment);
  • Patients with epilepsy or those using psychiatric drugs or sedatives at screening (excluding those used for sleep purposes);
  • Pregnant or breastfeeding women, and patients with reproductive potential (male and female) who refuse to use contraceptive measures during the trial and for 6 months after the trial;
  • Patients who have had another malignancy within 5 years before the first dose (excluding cured in-situ carcinoma and basal cell carcinoma of the skin);
  • Patients with other severe diseases that, in the investigator's opinion, may affect safety or compliance;
  • Patients who participated in other clinical trials of investigational drugs or medical devices within 1 month before the first dose and used the investigational drug or device;
  • Use of any treatment for MF (other than JAK inhibitors) within 2 weeks or 5 half-lives (whichever is longer) before the first dose, any immunomodulatory agents (e.g., thalidomide), any immunosuppressants, ≥10 mg/day prednisone or equivalent biological potency corticosteroids, or growth factors (e.g., erythropoietin (EPO)) (Traditional Chinese medicine should be stopped 1 day before the first dose);
  • Patients with a history of congenital or acquired bleeding disorders;
  • Other factors that the investigator deems unsuitable for participation in the trial.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • West China Hospital Sichuan University

    Chengdu, Sichuan, 610000

  • Hematology Hospital, Chinese Academy of Medical Sciences

    Tianjin, Tianjin Municipality, 300052

Other trials in China

About this study

Official title: An Open-Label, Positive Drug-Controlled, Parallel, Multicenter Phase II Clinical Trial of the Efficacy, Safety, and Pharmacokinetics of Flonoltinib Maleate Tablets in Patients With Intermediate to High-Risk Myelofibrosis

This trial adopts a multicenter, open-label, positive drug parallel control clinical trial design, planning to enroll approximately 75 MF participants. Eligible participants will be stratified and assigned in a 1:1:1 ratio to the low-dose flonoltinib maleate tablet group, high-dose flonoltinib maleate tablet group, or the ruxolitinib tablet group. Stratification factor include the Dynamic International Prognostic Scoring System (DIPSS) risk classification (intermediate-2 and high risk)

Being tested
Flonoltinib 50mg, Flonoltinib 100mg, Ruxolitinib

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Flonoltinib 50mgDrug

    Flonoltinib 50mg, QD

  • Flonoltinib 100mgDrug

    Flonoltinib 100mg, QD

  • RuxolitinibDrug

    For patients with platelet counts between 100×10^9/L and 200×10^9/L, the recommended starting dose is 15 mg twice daily (bid). For patients with platelet counts >200×10^9/L, the recommended starting dose is 20 mg bid. For patients with platelet counts between 50×10^9/L and <100×10^9/L, the recommended maximum starting dose is 5 mg bid.

Study groups in NCT06457425
Study groupRoleWhat they receive
low dose groupExperimentalFlonoltinib 50mg
Receives: Drug: Flonoltinib 50mg
high dose groupExperimentalFlonoltinib 100mg
Receives: Drug: Flonoltinib 100mg
control groupActive comparatorRuxolitinib
Receives: Drug: Ruxolitinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of subjects with ≥35% reduction in spleen volume from baseline(Evaluation by IRC)

    Percentage of subjects with ≥35% reduction in spleen volume from baseline(Evaluation by IRC)

    Measured: Week 24

Secondary outcomes (5)

  1. Percentage of subjects with ≥35% reduction in spleen volume from baseline (Evaluation by researcher)

    Percentage of subjects with ≥35% reduction in spleen volume from baseline(Evaluation by researcher)

    Measured: Week 24

  2. Percentage of subjects with ≥35% reduction in spleen volume from baseline (Evaluation by researcher)

    Percentage of subjects with ≥35% reduction in spleen volume from baseline (Evaluation by researcher)

    Measured: Week 12

  3. Percentage of subjects with ≥35% reduction in spleen volume from baseline (Evaluation by IRC)

    Percentage of subjects with ≥35% reduction in spleen volume from baseline( Evaluation by IRC)

    Measured: Week 12

  4. Percentage of subjects with ≥50% reduction in MPN-SAF TSS scale total symptom score

    Percentage of subjects with ≥50% reduction in MPN-SAF TSS scale total symptom score

    Measured: Week 24 and Week 12

  5. Objective response rate (ORR = CR + PR) per the IWG-MRT consensus criteria.

    Objective response rate (ORR = CR + PR) per the IWG-MRT consensus criteria.

    Measured: Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2024
  2. Study start6 May 2024
  3. Primary completion26 Nov 2025
  4. Study completion12 May 2027 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06457425
Sponsor's protocol ID
FMF-02
Status last verified
Apr 2026
First submitted
7 Jun 2024
Last updated
12 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Yang L, Tan K, Liang R, Zhang W, Wang Y, Chen L. Assessment of flonoltinib maleate versus ruxolitinib phosphate in intermediate- to high-risk myelofibrosis (FMF-02): study protocol for a multicenter, randomized, open-label phase IIB trial. Ther Adv Hematol. 2026 Mar 19;17:20406207261424845. doi: 10.1177/20406207261424845. eCollection 2026.

    PubMed 41883618

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Flonoltinib 50mg, Flonoltinib 100mg and Ruxolitinib in people with MF,PMF,PPV-MF,PET-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 20 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: under way, not looking for participants, as of the sponsor's last update on 12 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. 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(Evaluation by IRC) (time frame: Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06457425, which also lists 1 linked publication.

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 12 Aug 2026.

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