Tests TL-895 with ruxolitinib in adults with myelofibrosis
Tests TL-895 combined with ruxolitinib in adults with myelofibrosis, a bone marrow disease.
Plain-language title generated from the registry record
Registry title: Study of TL-895 Combined With Ruxolitinib in JAKi Treatment-Naïve MF Subjects and Subjects With MF Who Have a Suboptimal Response to Ruxolitinib
Key facts
- Where
- Bologna, Milan, and Perugia, ItalySee the 3 sites
- Phase
- Phase 1/2
Where in Italy
- IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'OrsolaBologna, ItalyTaking people
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di MilanoMilan, ItalyTaking people
- Azienda Ospedaliera di Perugia;Ospedale S. Maria della MisericordiaPerugia, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Telios Pharma, Inc.
- Trial code
- NCT05280509
- Record updated
- 21 February 2023
- Original description
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.Read full original descriptionShow less
An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of TL-895 Combined With Ruxolitinib in Janus-associated Kinase Inhibitor (JAKi) Treatment-Naïve Myelofibrosis (MF) Subjects and Subjects With MF Who Have a Suboptimal Response to Ruxolitinib
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.
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: Prior treatment with any JAKi; Subjects with suboptimal response to ruxolitinib:; Prior splenectomy or splenic irradiation within 24 weeks prior to first dose of study treatment; Prior treatment with a BTK or BMX inhibitor; Documented disease progression while on ruxolitinib treatment; All subjects:; Treatment-naive subjects:.