About this trial
This study evaluates TL-895, a potent, orally-available and highly selective irreversible tyrosine kinase inhibitor for the treatment of Myelofibrosis. Participants must have MF (PMF, Post PV MF, or Post ET MF) who are JAKi treatment-naïve or those who have a suboptimal response to ruxolitinib.
Eligibility criteria
Qualifiers
Treatment with at a stable dose of ruxolitinib prior to study entry
Subjects ≥ 18 years of age and able to provide informed consent.
Confirmed diagnosis of PMF, post-PV MF, or post-ET MF, as assessed by treating physician according to the World Health Organization (WHO) criteria
High-risk, intermediate-2 risk, or intermediate-1 risk, defined by Dynamic International Prognostic System (DIPSS)
Disqualifiers
Prior treatment with any JAKi
Documented disease progression while on ruxolitinib treatment
Prior splenectomy or splenic irradiation within 24 weeks prior to first dose of study treatment
Prior treatment with a BTK or BMX inhibitor
Trial design
Treatments tested in this trial
- TL-895
- Ruxolitinib