Status:
RECRUITING
Study of TL-895 Combined With Ruxolitinib in JAKi Treatment-Naïve MF Subjects and Subjects With MF Who Have a Suboptimal Response to Ruxolitinib
Lead Sponsor:
Telios Pharma, Inc.
Conditions:
Myelofibrosis
Primary Myelofibrosis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 P...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 9 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT05280509
Start Date
June 9 2022
End Date
April 1 2027
Last Update
February 21 2023
Active Locations (19)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Gabrail Cancer Center
Canton, Ohio, United States, 44718
3
University of Cincinnati (UC)
Cincinnati, Ohio, United States, 45267
4
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030