New pill could help control blood disorder when standard drugs fail
NCT ID NCT07232290
First seen Jun 27, 2026 · Last updated Aug 14, 2026 · Updated 1 time
Summary
This study tests a new drug called flonoltinib maleate in 60 people with polycythemia vera (a condition where the body makes too many red blood cells) who cannot take or no longer respond to standard treatments. The goal is to see if the drug safely reduces red blood cell levels without needing blood removal procedures. The trial has two phases to find the best dose and confirm its effects.
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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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Feb 2028
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
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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 old and gender not limited when signing the informed consent form; 2. Diagnosed as PV according to WHO standards (2016 edition), and resistant/intolerant to hydroxyurea or interferon treatment (refer to attachments 1 and 2); 3. When screening, the peripheral blood blasts are 0%; 4. Meet any of the following criteria and achieve HCT\<= 45% before randomization/enrollment: 1)At least 2 Phlebotomy and/or apheresis treatments have been performed within 24 weeks prior to screening, with a minimum interval of 4 weeks between each treatment, and at least 1 treatment has occurred within 16 weeks prior to screening; 2)At least one Phlebotomy and/or apheresis treatment has been performed within the 16 weeks and HCT\>45% at the time of screening; 5.When screening, laboratory test indicators meet the following criteria: neutrophil count \>= 1.0 × 10 \^ 9/L, platelet count \>= 100 × 10 \^ 9/L and \<= 1000 × 10 \^ 9/L; ALT and AST\<= 2.5 × ULN; TBIL\<=2.0×ULN; Serum creatinine \<= 1.5 × ULN; 6.ECOG 0-2 points; 7.Can understand and voluntarily sign an informed consent form. Exclusion Criteria: 1. Individuals with allergies or suspected allergies to the test drug and its excipients; 2. The toxic reactions of previous anti-cancer treatments have not recovered to grade 1 or below (excluding hair loss, blood routine and blood biochemical indicators refer to inclusion criteria 4 and 5), or have not fully recovered from previous surgeries (having undergone major surgery within 4 weeks); 3. In addition to PV, any other myeloproliferative neoplasms (MPN), including post polycythemia vera myelofibrosis (PPV-MF), may also be present; 4. Any active infections that require systemic treatment (oral, intravenous, subcutaneous, intramuscular, etc.) during screening; 5. Patients with swallowing difficulties, chronic diarrhea, or oral absorption disorders are included in the screening process; 6. Patients with basic diseases that are difficult to control in combination with drug treatment during screening, including but not limited to: diabetes, hypertension , peripheral neuropathy ; 7. Screening for individuals who have experienced congestive heart failure (NYHA class III or above), unstable angina, myocardial infarction, cerebrovascular accidents with functional impairment, or require treatment for arrhythmia within the past 6 months; 8. Individuals with QTcF\>450 ms (male) and QTcF\>470 ms (female) on electrocardiogram during screening; 9. Individuals who have experienced active tuberculosis infection within the past year prior to screening, or those whose tuberculosis related test results indicate latent infection during screening; 10. Patients who have undergone splenectomy or splenic radiotherapy in the past; 11. When screening, any of the following situations exist: a) Hepatitis B surface antigen (HbsAg) or hepatitis B core antibody (HbcAb) is positive, and HBV-DNA detection is positive or above the upper limit of normal value; b) HCV antibody positive and HCV-RNA detection positive; c) Positive for anti Treponema pallidum antibody (TP Ab) and positive for Treponema pallidum non-specific antibody (PRP or TRUST) detection; d) Positive for Human Immunodeficiency Virus Antibody (HIV Ab); 12. Individuals with epilepsy or mental illnesses requiring medication during screening (excluding insomnia); 13. Individuals who have suffered from other malignant tumors within the past 5 years prior to the first administration (excluding cured carcinoma in situ and basal cell carcinoma of the skin); 14. Patients with congenital or acquired bleeding disorders or active thrombotic disorders during screening; 15. Combining other serious diseases during screening may affect patient safety or compliance, according to researchers; 16. Within 2 weeks prior to trial administration or within 5 half lives (whichever is longer), any therapeutic PV drugs have been used, including hydroxyurea, recombinant interferon - α (long-acting recombinant interferon - α treatment needs to be discontinued for 4 weeks), JAK inhibitors (such as Ruxolitinib), 32P (needs to be discontinued for 8 weeks), Busulfan, etc; 17. Patients who receive treatment with other clinical trial drugs or clinical trial medical devices before screening and have not fully eluted for at least 5 half lives or 1 month (whichever is longer); 18. Pregnant or lactating women; 19. Individuals who have the ability to conceive but refuse to use contraceptive measures during the trial period ;and within 6 months after the trial ends; 20. Vaccination with active or attenuated vaccines within 4 weeks prior to screening; 21. Researchers believe that there are other factors that are not suitable for participating in the experiment.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (IHCAMS)
RECRUITINGTianjin, China
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