Status:
RECRUITING
A Study to Evaluate Safety , Efficacy and Pharmacokinetics of WJ01024 Tablets Combined With Ruxolitinib in Patients With Myelofibrosis
Lead Sponsor:
Suzhou Junjing BioSciences Co., Ltd.
Conditions:
Intermediate- and High-risk Myelofibrosis (MF) Patients With Splenomegaly
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 conduc...
Detailed Description
Ruxolitinib tablets have been approved in China since April 2017 as the first-line treatment for most intermediate- and high-risk myelofibrosis (MF) patients with splenomegaly. Compared with supportiv...
Eligibility Criteria
Inclusion
- 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
- 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；
Key Trial Info
Start Date :
July 28 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 15 2028
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT06909136
Start Date
July 28 2025
End Date
May 15 2028
Last Update
October 1 2025
Active Locations (1)
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1
Henan Cancer Hospital
Zhengzhou, Zhengzhou, China, 450000