NCT04617028已完成3 期
A Randomized, Double-blind, Double-simulated, Parallel-controlled, Multicenter Phase III Study Evaluating the Efficacy and Safety of Jaktinib Versus Hydroxycarbamide in Patients With Intermediate-2 or High-risk Myelofibrosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Splenic response rate at Week 24
研究概览
简要总结
This study is to determine the efficacy of Jaktinib versus Hydroxycarbamid in participants with Intermediate-2 or High-risk myelofibrosis
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old,either male or female;
- •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;
- •High risk or intermediate-2 risk as defined by the Dynamic International Prognostic Scoring System (DIPSS) for Primary Myelofibrosis;
- •Subjects have no plan for stem cell transplantation in the near future;
- •Life expectancy of > 24 weeks;
- •ECOG performance status of 0-1;
- •Palpable splenomegaly at least 5 cm below left costal margin;
- •Peripheral blood blast count ≤ 10%;
- •Subjects who have not yet received treatment with a JAK inhibitor, or Subjects who have been treated with JAK inhibitors for ≤10 days;
- •Subjects have not received growth factor, thrombopoietin mimetics or platelet transfusion(s) within 2 weeks before the randomization; ANC≥ 1.0×10^9/L, platelet count ≥ 100×10^9/L within 2 days before the randomization;
- •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;
- •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);
- •If the subject is receiving Hydroxycarbamide treatment at screening, the drug must be discontinued ≥ 2 weeks before the randomization;
- •Meet the requirements of the ethics committee and willing to sign the informed consent form;
- •Ability to comply with trial and follow-up procedures.
排除标准
- •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;
- •Subjects with congestive heart failure, uncontrolled or unstable angina or myocardial infarction, cerebrovascular accident, or pulmonary embolism within 24 weeks prior to screening;
- •Subjects who have not fully recovered from surgical operation within 4 weeks prior to screening;
- •Subjects suffering from arrhythmia and requiring treatment at screening;
- •Subjects with clinical symptoms of active bacterial, viral, parasitic or fungal infections requiring treatment at screening;
- •Chest X-rays suggest an active lung infection at screening;
- •Subjects who had active tuberculosis infection within 48 weeks before screening;γ-Interferon release test suggests latent tuberculosis infection at screening;
- •Subjects who had undergone splenectomy, or received radiotherapy to the spleen within 48 weeks before screening;
- •Subjects with known human immunodeficiency virus (HIV), known active infectious Hepatitis B (HepB), and/or known active infectious Hepatitis C (HepC);
- •Subjects with epilepsy or patients who have received psychotropic drug or sedatives during screening;
- •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
- •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);
- •Subjects who are unsuitable to the trial in combination with other serious diseases, as identified by the investigator;
- •Subjects with suspected allergies to Jaktinib or its excipient;
- •Subjects who have participated in another clinical trial of a new drug or medical instrument within 12 weeks before screening.
研究组 & 干预措施
Jaktinib
Experimental
Participants will receive Jaktinib plus placebo to match Hydroxycarbamide.
干预措施: Jaktinib (Drug)
Jaktinib
Experimental
Participants will receive Jaktinib plus placebo to match Hydroxycarbamide.
干预措施: Placebo to match Hydroxycarbamide (Drug)
Hydroxycarbamide
Active Comparator
Participants will receive Hydroxycarbamide plus placebo to match Jaktinib.
干预措施: Hydroxycarbamide Tablets (Drug)
Hydroxycarbamide
Active Comparator
Participants will receive Hydroxycarbamide plus placebo to match Jaktinib.
干预措施: Placebo to match Jaktinib (Drug)
结局指标
主要结局
Splenic response rate at Week 24
时间窗: 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
次要结局
- 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)
研究者
研究点 (1)
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