Actively Recruiting
An Open Label, Randomized, Parallel Controlled, Multicenter Phase IIa Study Evaluating Flonoltinib Maleate Tablets in Hydroxyurea or Interferon Resistant/Intolerant Polycythemia Vera
Led by Chengdu Zenitar Biomedical Technology Co., Ltd · Updated on 2026-03-04
60
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a Phase IIa clinical trial to study Flonoltinib Maleate Tablets in patients with polycythemia vera (PV) who are resistant or intolerant to hydroxyurea or interferon treatments. Polycythemia vera is a bone marrow disorder with a goal of preventing thrombosis and disease progression. This trial involves an open, randomized, parallel-controlled, multicenter design to evaluate safety, effectiveness, and how the body processes the drug. The trial has two stages: a dose exploration phase with three dose groups (75mg, 100mg, and 125mg) where each group includes three subjects for 8 weeks of daily oral treatment on an empty stomach; and a dose extension phase selecting 2-3 doses based on safety, efficacy, and pharmacokinetic data from the first stage. Participants receive Flonoltinib once daily, with doses adjusted as needed during the extension. Participants will undergo regular assessments including blood tests to control hematocrit levels, symptom scoring using the MPN-SAF TSS scale, and monitoring for thrombosis or bleeding. The primary outcome is the proportion of subjects achieving hematocrit control at week 28. Secondary measures include hematological remission, symptom changes, gene mutation burden, and safety evaluations. The study lasts at least 28 weeks with follow-up visits to monitor results and drug effects.
CONDITIONS
Brief 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
- Diagnosed with polycythemia vera according to WHO 2016 standards
- Resistant or intolerant to hydroxyurea or interferon treatment
- Peripheral blood primitive cells 0% at screening
- Meet criteria for hematocrit control with HCT ≤ 45% before enrollment
- Neutrophil count ≥ 1.0 × 10^9/L
- Platelet count between 100 × 10^9/L and 1000 × 10^9/L
- Liver enzymes ALT and AST ≤ 2.5 times upper limit of normal
- Total bilirubin ≤ 2.0 times upper limit of normal
- Serum creatinine ≤ 1.5 times upper limit of normal
- ECOG performance status 0-2
- Able to understand and sign informed consent form
You will not qualify if you...
- Allergy or suspected allergy to the study drug or its ingredients
- Unrecovered toxic reactions from prior anti-cancer treatments above grade 1 (except hair loss and blood counts)
- Not fully recovered from major surgery within 4 weeks
- Presence of other myeloproliferative neoplasms besides PV
- Active infections needing systemic treatment during screening
- Swallowing difficulties, chronic diarrhea, or oral absorption disorders
- Uncontrolled chronic diseases such as diabetes, hypertension, or peripheral neuropathy
- History of severe heart failure, unstable angina, myocardial infarction, stroke with impairment, or arrhythmia treatment within past 6 months
- Abnormal electrocardiogram QTcF values above specified limits
- Active or latent tuberculosis infection
- Previous splenectomy or splenic radiotherapy
- Positive tests for hepatitis B, hepatitis C, syphilis, or HIV infections
- Epilepsy or mental illness requiring medication (excluding insomnia)
- History of other malignant tumors within 5 years (except certain skin cancers)
- Congenital or acquired bleeding or active thrombotic disorders
- Other serious diseases affecting safety or compliance
- Recent use of PV treatments or clinical trial drugs within defined washout periods
- Pregnant or breastfeeding women
- Ability to conceive but refusing contraception during and 6 months after trial
- Vaccination with active or attenuated vaccines within 4 weeks prior to screening
- Other factors judged unsuitable by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants take Flonoltinib Maleate Tablets once daily on an empty stomach for 8 consecutive weeks. Participants are assigned to one of several dose groups during this period.
Weekly visits for up to 8 weeks
Duration - Up to 44 weeks after treatment
Participants are monitored for treatment outcomes including hematocrit control, symptom changes, and safety for up to 52 weeks after treatment begins.
Visits at weeks 16, 28, 40, and 52
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
L
Liangkun Sun
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here