Jaktinib Versus Hydroxycarbamide in Subjects With Intermediate-2 or High-risk Myelofibrosis
Study Details
Study Description
Brief Summary
This study is to determine the efficacy of Jaktinib versus Hydroxycarbamid in participants with Intermediate-2 or High-risk myelofibrosis
Condition or Disease | Intervention/Treatment | Phase |
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Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Jaktinib Participants will receive Jaktinib plus placebo to match Hydroxycarbamide. |
Drug: Jaktinib
Jaktinib Hydrochloride Tablets administered orally twice daily
Drug: Placebo to match Hydroxycarbamide
Placebo to match Hydroxycarbamide Tablets administered orally twice daily
|
Active Comparator: Hydroxycarbamide Participants will receive Hydroxycarbamide plus placebo to match Jaktinib. |
Drug: Hydroxycarbamide Tablets
Hydroxycarbamide Tablets administered orally twice daily
Drug: Placebo to match Jaktinib
Placebo to match Jaktinib Tablets administered orally twice daily
|
Outcome Measures
Primary Outcome Measures
- Splenic response rate at Week 24 [Week 24]
Splenic response rate at Week 24 is defined as the proportion of participants achieving a ≥ 35% reduction in spleen volume at Week 24 from baseline as measured by MRI or CT
Secondary Outcome Measures
- Proportion of transfusion dependent patients converted to non-transfusion dependent patients at baseline [From start of drug administration up to 7 days after last dose of study treatment]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥ 18 years old,either male or female;
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Subjects diagnosed with a PMF according to World Health Organiztion criteria (2016 Edition), or patients diagnosed with a Post-PV-MF or Post-EF-MF according to International Working Group for Myeloproliferative Neoplasms Research and Treatment criteria;
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High risk or intermediate-2 risk as defined by the Dynamic International Prognostic Scoring System (DIPSS) for Primary Myelofibrosis;
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Subjects have no plan for stem cell transplantation in the near future;
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Life expectancy of > 24 weeks;
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ECOG performance status of 0-1;
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Palpable splenomegaly at least 5 cm below left costal margin;
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Peripheral blood blast count ≤ 10%;
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Subjects who have not yet received treatment with a JAK inhibitor, or Subjects who have been treated with JAK inhibitors for ≤10 days;
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Subjects have not received growth factor, thrombopoietin mimetics or platelet transfusion(s) within 2 weeks before the randomization; ANC≥ 1.0×109/L, platelet count ≥ 100×109/L within 2 days before the randomization;
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Normal functions in major organs within 7 days before the randomization, fulfilling the following criteria: ALT and AST ≤ 2.5×ULN; DBIL and TBIL ≤ 2.0×ULN; serum creatinine ≤ 1.5×ULN;
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If the subject is receiving any anti-myelofibrosis treatment (except for JAK inhibitors and hydroxyurea) at screening, the dosing regimen must remain unchanged for at least 2 weeks before screening. If the investigator judges that there is no need to continue to use, stop the use of thalidomide, androgens and prednisone> 10 mg during screening. The drugs used to improve anemia should be stopped for at least 6 half-lives or 2 weeks before randomization(whichever is the longer);
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If the subject is receiving Hydroxycarbamide treatment at screening, the drug must be discontinued ≥ 2 weeks before the randomization;
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Meet the requirements of the ethics committee and willing to sign the informed consent form;
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Ability to comply with trial and follow-up procedures.
Exclusion Criteria:
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Subjects with any significant clinical and laboratory abnormalities which may affect the safety evaluation, such as uncontrolled diabetes, uncontrolled hypertension after taking two or more hypotensive drugs, peripheral neuropathy;
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Subjects with congestive heart failure, uncontrolled or unstable angina or myocardial infarction, cerebrovascular accident, or pulmonary embolism within 24 weeks prior to screening;
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Subjects who have not fully recovered from surgical operation within 4 weeks prior to screening;
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Subjects suffering from arrhythmia and requiring treatment at screening;
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Subjects with clinical symptoms of active bacterial, viral, parasitic or fungal infections requiring treatment at screening;
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Chest X-rays suggest an active lung infection at screening;
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Subjects who had active tuberculosis infection within 48 weeks before screening;γ-Interferon release test suggests latent tuberculosis infection at screening;
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Subjects who had undergone splenectomy, or received radiotherapy to the spleen within 48 weeks before screening;
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Subjects with known human immunodeficiency virus (HIV), known active infectious Hepatitis B (HepB), and/or known active infectious Hepatitis C (HepC);
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Subjects with epilepsy or patients who have received psychotropic drug or sedatives during screening;
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Female subjects who are pregnant, currently breastfeeding, planning to become pregnant;Subjects who are unable to adopt effective contraceptive methods during the study; Male subjects who did not use condoms during the dosing period and within 2 days after the last dose
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Subjects who had experienced malignant tumors within the past 5 years (except for adequately treated local basal cell carcinoma of the skin and cervical carcinoma in situ that have been cured);
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Subjects who are unsuitable to the trial in combination with other serious diseases, as identified by the investigator;
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Subjects with suspected allergies to Jaktinib or its excipient;
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Subjects who have participated in another clinical trial of a new drug or medical instrument within 12 weeks before screening.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | The First Affiliated Hospital of Medical School of Zhejiang University | Hangzhou | Zhejiang | China | 310003 |
Sponsors and Collaborators
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Investigators
- Study Chair: Jie Jin, PhD, The First Affiliated Hospital of Medical School of Zhejiang University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ZGJAK016