Study of TL-895 Combined With Ruxolitinib in JAKi Treatment-Naïve MF Subjects and Subjects With MF Who Have a Suboptimal Response to Ruxolitinib

Launched by TELIOS PHARMA, INC. · Mar 5, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called TL-895, which is being tested for its ability to help patients with myelofibrosis (MF), a type of blood cancer that affects the bone marrow. The trial is looking for two groups of participants: those who have never received treatment with a JAK inhibitor (like ruxolitinib) and those who have been on ruxolitinib but are not getting the best results. To be eligible, participants need to be at least 18 years old and have a confirmed diagnosis of myelofibrosis, which includes different types such as primary myelofibrosis and post-PV or post-ET myelofibrosis.

If you decide to participate in this study, you can expect to take TL-895 orally while being monitored by the research team. They will check your blood and overall health to ensure the treatment is safe and effective. It's important to know that some people may not qualify for the trial, especially if they have had previous treatments that could interfere with the study. This trial offers a chance to access a potentially beneficial treatment option while contributing to research that could help others with myelofibrosis in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Subjects with suboptimal response to ruxolitinib:
• • 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)
• • Palpable spleen measuring ≥ 5 cm below the left lower coastal margin (LLCM) or spleen volume of ≥ 450 cm3 by MRI or CT scan assessment
• • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
• • Adequate hematological, hepatic, \& renal function.
• Exclusion Criteria:
• Treatment-naive subjects:
• • Prior treatment with any JAKi
• Subjects with suboptimal response to ruxolitinib:
• • Documented disease progression while on ruxolitinib treatment
• All subjects:
• • Prior splenectomy or splenic irradiation within 24 weeks prior to first dose of study treatment
• • Prior treatment with a BTK or BMX inhibitor