A Study to Evaluate Safety , Efficacy and Pharmacokinetics of WJ01024 Tablets Combined With Ruxol… (NCT06909136) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
A Study to Evaluate Safety , Efficacy and Pharmacokinetics of WJ01024 Tablets Combined With Ruxolitinib in Patients With Myelofibrosis
China33 participantsStarted 2025-07-28
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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；
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
AE
Timeframe: 3 years
2
SVR35
Timeframe: 3 years
3
The absolute value changes of the total symptom score in MPN-SAF-TSS