Can a new pill shrink the spleen in myelofibrosis?
NCT ID NCT07802405
First seen Sep 03, 2026 · Last updated Sep 04, 2026 · Updated 1 time
Summary
This early-stage trial tests an experimental pill called WJ01024 in people with myelofibrosis, a bone marrow disorder that often causes an enlarged spleen. The study has two parts: one gives WJ01024 alone to patients whose previous JAK inhibitor treatment stopped working, and the other gives WJ01024 together with the standard drug ruxolitinib to patients who have not yet tried a JAK inhibitor. Researchers are checking how safe the drug is, what doses are tolerable, and whether it can reduce spleen size and ease symptoms.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- WJ01024, an experimental oral drug, tested alone and in combination with ruxolitinib
- What this could lead to
- If WJ01024 proves safe and effective, it could offer a new treatment option for myelofibrosis, especially for patients who no longer respond to JAK inhibitors or who need a stronger combination therapy.
- What could go wrong
- This is an early Phase 1 trial with only 20 participants, so the main goals are safety and dosing, not proof of benefit. The drug may cause side effects or fail to shrink spleens or improve symptoms in larger studies.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2023
- Expected to finish
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Nov 2027
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 days and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. The subjects voluntarily participated in this study after obtaining full informed consent and signed the informed consent form. 2. Age ≥18 years old, gender not limited; 3. Patients diagnosed with primary myelofibrosis (PMF) according to the 2016 World Health Organization (WHO) criteria, or patients diagnosed with post-essential thrombocythemia MF (PET-MF) or post-polycythemia vera MF (PPV-MF) according to International Working Group for Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) criteria; 4. Patients evaluated as intermediate-1, intermediate-2, or high-risk according to the International Prognostic System (DIPSS) scoring system;; 5. Expected life expectancy is ≥ 24 weeks; 6. Eastern Cooperative Oncology Group (ECOG) score of 0-2 ; 7. No planned for stem cell transplantation in the near future. 8. Splenomegaly: Palpation of the spleen margin reaches or exceeds at least 5cm below the costal margin (the distance from the costal margin to the farthest point of the spleen protrusion), or spleen volume ≥450cm ³ by CT or MRI. 9. Adequate hematological and organ function within 7 days before the first administration of the study drug (no RBC transfusion, growth factors, colony-stimulating factors, platelet-generating factors ,or platelet transfusion within 14 days before the testing) : * Absolute neutrophil count (ANC) ≥1.5×109/L; * Platelet count ≥75×109/L(Phase IA); Platelet count ≥100×109/L(Phase IB); Hemoglobin ≥ 8.0g /dL; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0× upper limit of normal (ULN); Total bilirubin ≤1.5×ULN; Creatinine ≤1.5×ULN. 10. For women of childbearing age, within 7 days before the first administration, if the serum pregnancy test is confirmed to be negative and they agree to use effective contraceptive measures during the study drug period and within 90 days after the last administration. For male subjects whose sexual partners are women of childbearing age, they must agree to take effective contraceptive measures during the use of the study drug and within 90 days after the last administration. Exclusion Criteria: * Peripheral blood blasts \>5% or Bone marrow blasts \>10%. * 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 strong CYP3A inhibitors or inducers within 14 days prior to initial administration"
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Henan Cancer Hospital
RECRUITINGZhengzhou, Henan, 450000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a Dual-Action pill tame bone marrow tumors?
- Can a new pill shrink the spleen in myelofibrosis?
- Can a daily pill shrink the spleen in myelofibrosis?
- Could a platelet-boosting drug shorten recovery after stem cell transplants?
- Can a modified interferon rein in early myelofibrosis?
- Can a drug free myelofibrosis patients from frequent blood transfusions?