Ruxolitinib phosphate tablet（Jakavi,NOVARTIS,9104733): 5-20mg BID (dosage per investigator judgement,JAKi intolerable pts will receive recuded dose of RUX(≥ 5mg BID),and suboptimal JAKi response pts will receive RUX of 15-20 mg BID）
Study summary
This is a Phase Ib/II clinical study to evaluate the safety , efficacy and pharmacokinetics of WJ01024 tablets combined with Ruxolitinib tablets in patients with myelofibrosis.The study will be conducted in two phases: Phase 1b and Phase 2.Phase Ib is a dose extension study of WJ01024 tablets combined with ruxolitinib tablets. It is planned to recruit patients with medium to high-risk myelofibrosis accompanied by splenomegaly who have had poor response or intolerance to the previously approved JAK inhibitors for myelofibrosis. Phase II is the efficacy extension stage of WJ01024 tablets combined with ruxolitinib Tablets. It is planned to expand two groups of people. Group A will expand to recruit patients with medium-high risk of myelofibrosis accompanied by splenomegaly who have not responded well to the previously approved JAK inhibitors for myelofibrosis. Group B expanded to recruit patients with medium-high-risk myelofibrosis accompanied by splenomegaly who were intolerant after treatment with previously approved JAK inhibitors for myelofibrosis.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Subjects voluntarily participate in the study after receiving full informed consent and sign informed consent;
* Age ≥18 years old, gender unlimited;
* Patients diagnosed with primary myelofibrosis (PMF) according to WHO criteria (2016 edition), or with ET secondary myelofibrosis (PET-MF) or PV secondary myelofibrosis (PPV-MF) according to International Working Group on Myelofibrosis Research and Treatment (IWG-MRT) criteria; They could be included regardless of JAK2 mutation；
* Participants with international prognostic scoring system (DIPSS) risk category of intermediate-1, or intermediate-2, or high-risk；
* ECOG score 0\~2;
* No stem cell transplantation plan in the near future;
* Spleen enlargement:palpable splenomegaly(≥5cm below left costal margin)or radiologically confirmed spleen volume ≥450 cm\^3 using MRI/CT;
* Patients with intolerance or a suboptimal response to prior JAK inhibitor therapy；
* Sufficient hematology and organ function；
Exclusion Criteria:
* More than 10% blasts in peripheral blood or bone marrow；
* Previous treatment with XPO1 inhibitors；
* Unable to cooperate with or unable to perform MRI or CT scans as deemed necessary by sponsor and investigator；
* Treatment with a powerful CYP3A inhibitor or inducer within 14 days prior to initial administration；
Primary outcome measure(s)
AE — 3 years Incidence rate and severity of adverse events and serious adverse events,as well as abnormal changes in clinical significance laboratory tests and other examinations
SVR35 — 3 years At weeks 12 and 24, the ratio of splenic volume reduction ≥35% (SVR35) was assessed by the investigator
The absolute value changes of the total symptom score in MPN-SAF-TSS — 3 years The absolute value changes of the overall symptom score in MPN-SAF-TSS based on subject assessment in weeks 12 and 24 compared with the baseline
Trial sites (1)
Facility
City
Region
Status
Henan Cancer Hospital
Zhengzhou
Zhengzhou
More Suzhou Junjing BioSciences Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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