Actively Recruiting
Phase IIa Study on Flonoltinib Maleate Tablets in the Treatment of Patients With Polycythemia Vera
Led by Chengdu Zenitar Biomedical Technology Co., Ltd · Updated on 2026-03-04
60
Participants Needed
1
Research Sites
126 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial adopts an open, randomized, parallel controlled, multicenter clinical trial design planning to enroll patients with polycythemia vera who are resistant/intolerant to hydroxyurea or interferon。The study divided into two stages: dose exploration stage: three dose groups are tentatively set, with three subjects in each group, totaling nine subjects in each group; Dose extension stage: Based on the safety, efficacy, and pharmacokinetic results of the comprehensive dose exploration stage, 2-3 dose groups are planned to be selected for dose extension trials.
CONDITIONS
Official Title
Phase IIa Study on Flonoltinib Maleate Tablets in the Treatment of Patients With Polycythemia Vera
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older with no gender restriction and able to sign informed consent
- Diagnosed with polycythemia vera according to WHO 2016 standards and resistant or intolerant to hydroxyurea or interferon
- Peripheral blood primitive cells equal to 0% at screening
- Meet criteria for hematocrit control (HCT ≤ 45%) before enrollment, including specific prior bloodletting or apheresis treatments
- Laboratory tests at screening show neutrophil count ≥ 1.0 × 10^9/L, platelet count between 100 × 10^9/L and 1000 × 10^9/L
- Liver function tests (ALT and AST) ≤ 2.5 times upper limit of normal (ULN)
- Total bilirubin ≤ 2.0 times ULN
- Serum creatinine ≤ 1.5 times ULN
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Able to understand and voluntarily sign informed consent
You will not qualify if you...
- Allergy or suspected allergy to the study drug or its components
- Toxic reactions from prior anti-cancer treatments not recovered to grade 1 or below (excluding hair loss and routine labs)
- Major surgery within 4 weeks prior to screening
- Diagnosed with other myeloproliferative neoplasms besides polycythemia vera
- Active infections requiring systemic treatment during screening
- Difficulty swallowing, chronic diarrhea, or oral absorption disorders
- Uncontrolled medical conditions such as diabetes, hypertension, or peripheral neuropathy
- History of severe heart failure, unstable angina, recent myocardial infarction, cerebrovascular accident with impairment, or arrhythmia treatment within 6 months
- Electrocardiogram showing QTcF >450 ms (male) or >470 ms (female)
- Active or latent tuberculosis infection
- Previous splenectomy or splenic radiotherapy
- Positive tests for hepatitis B or C, syphilis, or HIV infection
- Epilepsy or mental illness requiring medication (excluding insomnia)
- Other malignant tumors within 5 years except certain skin or in situ cancers
- Bleeding or active thrombotic disorders
- Other serious diseases affecting safety or compliance
- Use of therapeutic PV drugs or other clinical trial drugs/devices within specified washout periods
- Pregnant or breastfeeding women
- Ability to conceive but refusing contraception during study and 6 months after
- Vaccination with active or attenuated vaccines within 4 weeks prior to screening
- Any other factors deemed unsuitable by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (IHCAMS)
Tianjin, China
Actively Recruiting
Research Team
F
Fangmei Wang
CONTACT
L
Liangkun Sun
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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