Can a new pill shrink the spleen in myelofibrosis?
NCT ID NCT06457425
First seen Aug 12, 2026 · Last updated Aug 13, 2026 · Updated 1 time
Summary
This trial is testing an experimental drug called flonoltinib in people with intermediate to high-risk myelofibrosis, a type of bone marrow cancer that often causes an enlarged spleen. Participants will be randomly assigned to receive either a low or high dose of flonoltinib, or the standard drug ruxolitinib. The main goal is to see if flonoltinib can reduce spleen size by at least 35%, which would indicate it may be a useful treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- flonoltinib maleate tablets
- What this could lead to
- If successful, flonoltinib could offer a new treatment option for myelofibrosis, potentially reducing spleen size and improving symptoms.
- What could go wrong
- This is an early-phase trial with a small number of participants. It may not show a clear benefit over the existing drug ruxolitinib, and side effects are still being evaluated.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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75 people
The number who actually took part.
- Started
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May 2024
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age ≥ 18 years, no gender restrictions; 2. 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; 3. Evaluated as intermediate-2 or high-risk myelofibrosis according to the Dynamic International Prognostic Scoring System (DIPSS) risk classification; 4. Expected survival ≥ 24 weeks; 5. ECOG score of 0-2; 6. 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; 7. 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. Exclusion Criteria: 1. 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); 2. Hypersensitivity, allergic to the investigational drug or its excipients; 3. Previous intolerance or resistance to ruxolitinib; 4. Use of JAK inhibitors within 4 weeks before the first dose; 5. Any significant clinical and laboratory abnormalities that, in the investigator's opinion, affect safety evaluation; 6. History of congestive heart failure, unstable angina, myocardial infarction, cerebrovascular accident (excluding lacunar infarction), or pulmonary embolism within 6 months prior to screening; 7. Impaired cardiac function or arrhythmic disease requiring treatment at screening; 8. Any active infection requiring intravenous antibiotic treatment at screening; 9. Active tuberculosis infection within 48 weeks prior to screening or latent tuberculosis infection indicated by tuberculosis-related tests during the screening period; 10. Patients who have undergone splenectomy or received radiation therapy to the spleen area within 12 months before the first dose; 11. 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. 12. 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); 13. Patients with epilepsy or those using psychiatric drugs or sedatives at screening (excluding those used for sleep purposes); 14. 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; 15. 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); 16. Patients with other severe diseases that, in the investigator's opinion, may affect safety or compliance; 17. 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; 18. 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); 19. Patients with a history of congenital or acquired bleeding disorders; 20. Other factors that the investigator deems unsuitable for participation in the trial.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Hematology Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, 300052, China
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West China Hospital Sichuan University
Chengdu, Sichuan, 610000, China
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