A Phase 2 interventional study of Flonoltinib Maleate orally and Flonoltinib Maleate orally in Myelofibrosis, Myelofibrosis Due to and Following Polycythemia Vera and Myelofibrosis Transformation in Essential Thrombocythemia, sponsored by Chengdu Zenitar Biomedical Technology Co., Ltd. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Chengdu Zenitar Biomedical Technology Co., Ltd · Phase 2, Interventional, and Treatment
The goal of this clinical trial is to learn which of three different doses of Flonoltinib Maleate taken by mouth daily works best to treat adult patients with myelofibrosis in whom the most common approved therapy has failed to adequately control the disease. It will also learn about the safety of the three different daily doses of Flonoltinib Maleate. The main questions it aims to answer are:
Which dose is the best at controlling the symptoms and signs of organ damage caused by myelofibrosis? What medical problems do participants have when taking the three different doses of Flonoltinib Maleate? Researchers will compare the three different doses of Flonoltinib Maleate to see which dose is best to treat patients with myelofibrosis.
Participants will:
Take Flonoltinib Maleate every day for as long as it seems to be of benefit to them in terms of controlling myelofibrosis.
Visit the clinic for checkups and tests after giving fully informed written consent confirming that they would like to consider entering the study.
Visit the clinic for checkups and tests when on the study once every 2 weeks for the first 2 months, every 4 weeks after that, and when coming off study therapy.
Keep a diary of their symptoms.
Flonoltinib Maleate (FM) is a triple-targeted inhibitor of JAK2/FLT3/cyclin-dependent kinase 6 (CDK6). Cocrystal structure of JAK2-JH2 domain in complex with FM revealed that FM binds both to the pseudokinase domain (JH2) and kinase domain (JH1) of JAK2 and achieves high selectivity for the JAK family. FM has potent inhibitory activity against JAK family. The concentration required for 50% inhibition (IC50) of FM against JAK2 kinase is 0.8 nM, while the inhibitory IC50 of FM against JAK1, JAK3, and TYK2 kinases are 690 nM, 557 nM, and 65 nM, respectively, with a selective multiplicity of 862.5-fold, 696.3-fold, and 81.3-fold. FM has moderate inhibitory activity against FLT3 and CDK6, with IC50 values of 15 nM and 35 nM, respectively.
The Phase 2 FMF-02 study (NCT06457425) was a multi-center, open-label, randomized, controlled, parallel-cohort evaluating the efficacy and safety of FM compared to ruxolitinib in patients with intermediate-2 or high-risk MF. Key hematologic criteria for inclusion included PLT ≥50×109/L and HGB >60 g/L. A total of 75 patients were enrolled in three cohorts: (i) 25 patients in the FM low-dose cohort receiving 50 mg of FM once daily, (ii) 26 patients in the FM high-dose cohort receiving 100 mg of FM once daily, and (iii) 24 patients in the ruxolitinib twice daily cohort, with the starting dose determined based on the patient's baseline platelet levels. The study met its primary endpoint at week 24, demonstrating superior ≥ 35% reduction in spleen volume (SVR35) rates for both FM high (100mg qd) (FMH) and low dose (50mg qd) (FML) cohorts versus the ruxolitinib cohort (RUX). Patients in the RUX arm who completed 24 weeks of therapy or had progressive disease due to splenomegaly could cross over to FML or FMH group. Efficacy and safety endpoints were assessed at week 48, included SVR35, TSS50, bone marrow fibrosis improvement, and safety. With a median follow up of 60 weeks, 68 patients (90%) entered the extension phase, including 12 and 10 patients crossing over from RUX to FML and FMH respectively. At week 48, among evaluable patients on treatment, SVR35 was achieved/maintained in 74% (17/23) in FML and 95% (20/21) in FMH, compared with 80% (8/10) in RUX FML and 100% (9/9) in RUX FMH. Among the 19 crossover patients, 3 of 5 (60%) who had suboptimal responses to RUX at week 24 achieved SVR35 by week 48, with most crossovers showing deeper responses over time. At week 48, TSS50 response rates were 96% (22/23) in FML and 81% (17/21) in FMH, versus 60% (6/10) in RUX FML and 78% (7/9) in RUX FMH, with continued durability of symptom improvement observed through long-term follow-up. Durable dual SVR35 and TSS50 responses were observed in FML and FMH arms, with consistent benefit across subgroups through week 48, including patients with baseline platelet counts \<100 × 10⁹/L (3/3 in FML and 1/1 in FMH achieved dual response at week 48). Bone marrow fibrosis grade was stable or improved in 86% (19/22), 84% (16/19), 100% (9/9), and 100% (9/9) in FML, FMH, RUX FML and RUX FMH cohorts, respectively, among patients with evaluable week 48 biopsies. JAK2 V617F mutation variant allele frequency, was assessed at the end of treatment versus baseline, 2 of the 3 patients in the FMH group showed a reduction from baseline, with 1 patient achieving a 30% decrease. The most common Grade ≥3 hematologic treatment-emergent adverse event (TEAE) was anemia, with incidences of 4%, 14%, 8%, and 20% in extension period, respectively-markedly lower than rates observed during the initial 24 week period. No Grade ≥3 non hematologic TEAEs were reported in any of the four arms. Dose reductions due to TEAEs occurred in 13% (3/24), 27% (6/22), 8% (1/12), and 30% (3/10) of patients in the respective arms during the extension period, consistent with improved tolerability on long term treatment. Thus at week 48, spleen volume and TSS improvements were sustained in both FM cohorts. Patients who switched from RUX to FM after week 24 experienced additional benefits. These findings provided a compelling rationale for the continued development of FM for patients with MF including the conduct of this FM-MF-02 study.
This study is designed to characterize dose-response and support Recommended Phase 3 Dose (RP3D) selection for an intended randomized study of FM versus JAKi in patients with advanced refractory MF. This study will enroll 105 fully evaluable patients, including 42 JAKi-naïve and 63 JAKi-resistant patients randomized to 3 dose cohorts (50 mg, 75 mg, 100 mg), with 35 patients per cohort. The study will characterize the dose-response relationship of FM in patients with MF by evaluation of efficacy, safety and tolerability, pharmacokinetic (PK) profile, and pharmacodynamic (PD) effects. After signing the informed consent form (ICF), patients will undergo a 2-week screening period to confirm eligibility, followed by baseline assessments before entering the clinical study.
Participants in the 50 mg, 75 mg and 100 mg cohorts are concurrently enrolled and randomized. One stratification factor will be applied: intermediate-1 vs. intermediate-2/high for JAKi-naïve participants and JAKi-resistant participants.
Participants will be dosed for 28 consecutive days (a cycle) starting on the morning of Day 1. Blood samples from participants in each cohort will be collected according to the PK and biomarker sample collection time points. Participants will undergo safety evaluations (conducted on Days 14 and 28 of Cycles 1 to 2, Day 28 of Cycles 3, 4, 5, and 6, and every 3 treatment cycles [12 weeks] of subsequent dosing therapy). Participants will receive continuous treatment until unacceptable toxicities, progressive disease or meeting other stopping criteria. The key safety endpoints and clinical efficacy endpoints in this trial will be evaluated at the end of 6 cycles (24 weeks). Other efficacy and safety evaluations will be conducted every 3-6 cycles. Safety follow-up will be conducted 30 days after the last dose and all participants will be followed up for adverse events, serious adverse events (SAEs), and concomitant medication (including any new therapy) for 30 days following last FM dose. Dose adjustment shall be implemented based on hematologic/non-hematologic toxicities observed during treatment. Dose escalation may be considered for suboptimal response.
Cardiac safety will be monitored using a structured QTc Monitoring Plan. ECGs will be performed at baseline and at prespecified on-treatment time points, with additional assessments as clinically indicated. Predefined QTc thresholds will guide clinical management, including repeat ECG evaluation, assessment of electrolyte abnormalities and concomitant medications (other assessments such as cardiac biomarker, echocardiogram may be needed per institutional guideline), and implementation of dose interruption, modification, or discontinuation as appropriate. Clinically significant QTc prolongation or related cardiac events will trigger Safety Review Committee (SRC) review. Persistent or clinically significant QTc abnormalities may result in treatment discontinuation in accordance with Participant-level stopping criteria.
Study or cohort-level stopping decisions will be based on an integrated assessment of safety and efficacy by the SRC. An interim futility assessment will be performed at the earlier of 75% of participants enrolled, or after approximately 50% of participants in each dose cohort have completed the Week 12 evaluation. If the observed response rate (SVR35) is below 30%, the SRC may recommend discontinuation of that cohort.
Safety-based stopping criteria include:
Detailed study-level stopping criteria and patient-level discontinuation criteria are provided in the protocol.
The statistical analysis framework is based on dose-response characterization and an estimand-based approach, including predefined handling of intercurrent events and missing data. Statistical analyses will be conducted using SAS software version 9.4 (or above). Continuous variables will be summarized using the number of observations, mean, standard deviation, median, first quartile, third quartile, minimum, maximum, and, for outcomes, CIs. Categorical variables will be summarized using counts, percentages and, for outcomes, CIs. Time to Event variables will be summarized by number of observed events, median and associated CI. Comparisons between treatment doses will be based on normal regression for continuous variables, and logistic regression for categorical variables. Mixed Models with Repeated Measures will be used to assess the average treatment effect post-baseline on continuous variables. Dose will be fitted as a categorical variable, and models adjusted for baseline values. The 95% CIs for treatment effects will be presented, and for categorical variables, converted to risk differences for the observed population risk.
No adjustment will be made for multiple comparisons between treatment cohorts since this is a Phase 2 study, and no formal conclusions of efficacy will be drawn. Methods of statistical analysis of tolerance and safety The study will statistically analyze the tolerability data at different time points and doses. The tolerability analysis will be primarily descriptive. Safety statistical analysis includes statistical analysis of the incidence of adverse events/adverse reactions, list of adverse events, vital signs, laboratory tests, physical examination results, ECG examination, etc.
PK statistical analysis methodology Plasma PK concentrations will be summarized by nominal sample time and by dose cohort. The PK data will also be displayed graphically. For the intensively sampled data, PK parameters including but not limited to Cmax, Tmax, t1/2, and AUC will be determined from the concentration-time profile using standard noncompartmental approaches. Dose proportionality may also be evaluated.
The PK data may also be included in population PK modelling analysis and exposure-response analysis, and the results will be reported separately
625 studies on the registry are indexed under Primary Myelofibrosis; 124 are open to participants now.
This study's planned enrollment of 105 is above the median of 43 across 489 interventional studies indexed under Primary Myelofibrosis.
Browse Primary Myelofibrosis studies →Chengdu Zenitar Biomedical Technology Co., Ltd is the lead sponsor of 23 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Oct 16, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
All participants must:
Exclusion Criteria:
Participants must not:
Have any significant clinical or laboratory abnormality that would interfere with accurate safety evaluation on study, including:
Be women of (WOCBP): who are unwilling or unable to practice highly effective before the initial dose/start of the first treatment, during the study, and for at least 6 months after the last dose. Highly effective contraceptive measures include:
i) Stable use of combined (estrogen and progestogen-containing) hormonal contraception (oral, intravaginal, transdermal) or progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation initiated 2 or more menstrual cycles before screening; ii) Intrauterine device; intrauterine hormone-releasing system; iii) Sexual abstinence; iv) Intercourse with a vasectomized partner (the male vasectomized partner is the sole sexual partner of the WOCBP study patient, the vasectomized partner has obtained medical assessment of surgical success for the procedure);
Be sexually active male patients with WOCBP partners who are unwilling to use 1 of the following forms of medically acceptable birth control at the start of the first treatment, during the study, and for at least 6 months after the last dose:
i) Vasectomy with medical assessment of surgical success or consistent use of a condom; ii) Male Participants must also agree not to donate sperm while receiving the investigational product and for at least 6 months after the last dose;
Have any other severe and/or uncontrolled concomitant medical condition that in the opinion of the investigator could compromise participation in the study or analysis of study data.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This study arm will include 35 fully eligible and evaluable participants with myelofibrosis, including 14 JAKi-naïve and 63 JAKi-resistant, who are randomized to receive 50mg of oral Flonoltinib daily. Participants will receive continuous treatment until unacceptable toxicities, progressive disease or meeting other stopping criteria. The key safety endpoints and clinical efficacy endpoints will be evaluated at the end of 6 cycles (24 weeks). Other efficacy and safety evaluations will be conducted every 3 to 6 cycles. Safety follow-up will be conducted up to 30 days after the last dose and all participants will be followed up for adverse events, serious adverse events, and concomitant medication (including any new therapy) for 30 days following last Flonoltinib dose.
Drug: Flonoltinib Maleate orally
This study arm will include 35 fully eligible and evaluable participants with myelofibrosis, including 14 JAKi-naïve and 63 JAKi-resistant, who are randomized to receive 75mg of oral Flonoltinib daily. Participants will receive continuous treatment until unacceptable toxicities, progressive disease or meeting other stopping criteria. The key safety endpoints and clinical efficacy endpoints will be evaluated at the end of 6 cycles (24 weeks). Other efficacy and safety evaluations will be conducted every 3 to 6 cycles. Safety follow-up will be conducted up to 30 days after the last dose and all participants will be followed up for adverse events, serious adverse events, and concomitant medication (including any new therapy) for 30 days following last Flonoltinib dose.
Drug: Flonoltinib Maleate orally
This study arm will include 35 fully eligible and evaluable participants with myelofibrosis, including 14 JAKi-naïve and 63 JAKi-resistant, who are randomized to receive 100mg of oral Flonoltinib daily. Participants will receive continuous treatment until unacceptable toxicities, progressive disease or meeting other stopping criteria. The key safety endpoints and clinical efficacy endpoints will be evaluated at the end of 6 cycles (24 weeks). Other efficacy and safety evaluations will be conducted every 3 to 6 cycles. Safety follow-up will be conducted up to 30 days after the last dose and all participants will be followed up for adverse events, serious adverse events, and concomitant medication (including any new therapy) for 30 days following last Flonoltinib dose.
Drug: Flonoltinib Maleate orally
Dose of Flonoltinib Maleate will be 50mg daily
Dose of Flonoltinib Maleate will be 75mg daily
Dose of Flonoltinib Maleate will be 100mg daily
Percentage of participants with ≥35% reduction in spleen volume as assessed by imaging from baseline to week 24
The spleen volume as measured by a CT or MRI scan before study therapy commences will be compared with the spleen volume as measured by the same method as used at baseline. The percentage of participants who show a 35% or more reduction in spleen volume will be calculated.
Time frame: Baseline and at 24 weeks on study
Percentage of participants achieving a TSS50, as measured by the MFSAF v4.0 at week 24.
Participant will use the Myelofibrosis Symptoms Assessment Form to record their symptoms before they begin study therapy. They will repeat this at week 24 on study and the results recorded of the two forms will be compared. The percentage of participants who record a 50% or more reduction in their total symptom score will be calculated.
Time frame: Baseline and at 24 weeks on study
Absolute mean change in TSS from baseline to weeks 12 and 24 as measured by MFSAF V4.0
Participant records their symptoms on a standard form before starting study therapy and repeats this by completing the same form after 12 weeks and 24 weeks on study. The absolute mean change in their total symptom score between the 3 timepoints is calculated.
Time frame: Baseline and at 12 weeks and 24 weeks on study
Absolute mean change in TSS excluding fatigue from baseline to weeks 12 and 24
Participant records their symptoms on a standard form before starting study therapy and repeats this by completing the same form after 12 weeks and 24 weeks on study excluding completion of the fatigue-related question. The absolute mean change in their total symptom score between the 3 timepoints is calculated.
Time frame: Baseline, at weeks 12 and 24 on study
Percentage of patients achieving SVR35 from baseline to week 12 (IRC and investigator)
The spleen volume as measured by a CT or MRI scan before study therapy commences will be compared with the spleen volume as measured at week 12 by the same method as used at baseline. The percentage of participants who show a 35% or more reduction in spleen volume will be calculated. The percentages will be calculated independently by the study Independent Reading Center and the participant's study investigator.
Time frame: Baseline and at week 12 on study.
Percentage of patients with SVR35 from baseline to Week 24 (investigator
The spleen volume as measured by a CT or MRI scan before study therapy commences will be compared with the spleen volume as measured at week 24 by the same method as used at baseline. The percentage of participants who show a 35% or more reduction in spleen volume will be calculated. The percentages will be calculated by the participant's study investigator.
Time frame: Baseline and at 24 weeks on study
Spleen response time: time to first observed SVR35 from baseline
The spleen volume as measured by a CT or MRI scan before study therapy commences will be compared with the spleen volume as measured at week 12, week 24, week 36, and week 48 by the same method as used at baseline. The time it takes each participants who does so, to show a 35% or more reduction in spleen volume will be calculated.
Time frame: Baseline and at week 12, week 24, week 36, and week 48 on study
Splenic Best Response Rate: percentage of patients who experience a SVR35 from baseline
The spleen volume as measured by a CT or MRI scan before study therapy commences will be compared with the spleen volume as measured at weeks 12, 24, 36, and 48 by the same method as used at baseline. The percentage of participants who show a 35% or more reduction in spleen volume at any time on study will be calculated.
Time frame: Baseline and at weeks 12, week 24, week 36, and week 48 on study.
Duration of sustained splenic response, defined as the time from a ≥35% reduction in splenic volume from baseline until the increase in splenic volume is less than or equal to 25%
The spleen volume as measured by a CT or MRI scan before study therapy commences will be compared with the spleen volume as measured at weeks 12, 24, 36, 48 by the same method as used at baseline. The time from when a participants who show a 35% or more reduction in spleen volume to when she/he is documented to have a 25% or less reduction in spleen volume will be calculated.
Time frame: Baseline and at 12, 24, 36, and 48 weeks on study
Percentage of patients achieving a TSS50, as measured by MFSAF v4.0 at week 12
Participant records their symptoms on a standard form before starting study therapy and repeats this by completing the same form after 12 weeks on study. The percentage change between these 2 results is calculated and the TSS50 is calculated as the overall percentage of participants who have at least a 50% reduction in their total symptom score.
Time frame: Baseline and at 12 weeks on study
Rate of change from baseline in MFSAF v4.0 total score at weeks 12 and 24
Participant records their symptoms on a standard form before starting study therapy and repeats this by completing the same form after 12 weeks and 24 weeks on study. The rate of change between these 3 results is calculated.
Time frame: Baseline and at week 12 and week 24 on study
Rate of change from baseline in MFSAF v4.0 total score excluding fatigue at weeks 12 and 24;
Participant records their symptoms on a standard form before starting study therapy excluding the fatigue-related question and repeats this by completing the same form after 12 weeks and 24 weeks on study. The rate of change between these 3 results is calculated.
Time frame: At baseline and at week 12 and week 24 on study
Patient Global Impression of Change (PGIC) response rate at weeks 12 and 24
The participant will complete a single-item questionnaire at week 12 and week 24 on study
Time frame: At week 12 and week 24 on study
Leukemia-free survival (LFS), defined as the time from treatment to the first observation of blast cells >20% in bone marrow or peripheral blood smear
At each study visit, the peripheral blood will be examined for percentage of leukemia blasts. If this is above normal, a bone marrow examination will be performed to establish percentage of blasts and other evidence of acute leukemia.
Time frame: From study entry to end of study participation
Overall survival (OS), defined as the time from treatment initiation to death from any cause
The duration for each participant from time of study entry to date of death will be recorded.
Time frame: From time of study entry to date of death.
Objective response rate (ORR = Complete Response [CR] + Partial Response [PR]), defined according to IWG-MRT criteria and assessed at week 24
The percentage of participants who have responded to therapy will be calculated at week 24 of study using the standard assessments defined by the International Working Group for Myeloproliferative Neoplasms Research and Treatment for this purpose which include assessment of symptoms, blood counts, spleen size, transfusion requirements, and of blood counts and bone marrow cells.
Time frame: From enrollment to week 24 on study
No study locations are listed for this record.
Plan to share: Yes — IPD used in results publication
Supporting information: Study protocol, Statistical analysis plan
Time frame: Beginning 3 months and ending 3 years after the publication of results
Access criteria: All qualified investigators will be able to access the IPD and supporting information. Statistical methods for analyses must be approved by the study SRC. A planned analysis proposal must be submitted to neilwang@zenitar.cn. A data sharing agreement must be signed.
Data sharing details ↗ · en.zenitar.com.cn
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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