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
- Düsseldorf and Halle, GermanySee the 2 sites
- Phase
- Phase 1/2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with myelofibrosis (primary, post-PV or post-ET) who have not had a JAK inhibitor before, or who respond only partly to ruxolitinib.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Primary myelofibrosis, post-PV MF or post-ET MF. High-risk, intermediate-2 or intermediate-1 risk by DIPSS. Enlarged spleen: palpable 5 cm (2 in) or more below the left lower coastal margin, or spleen volume 450 cm3 or more on MRI or CT. ECOG performance status 0 to 2.
- Earlier treatment
- Two groups can join: people who never had a JAK inhibitor, and people on a stable dose of ruxolitinib with a suboptimal response. People who had a BTK or BMX inhibitor cannot join.
Main reasons for not taking part
- Earlier treatment with any JAK inhibitor (for the treatment-naive group)
- Disease getting worse while on ruxolitinib
- Spleen removal or spleen radiation within 24 weeks before the first dose
- Earlier treatment with a BTK or BMX inhibitor
Read by machine on 12 November 2026.
Where in Germany
- Marien Hospital DuesseldorfDüsseldorf, GermanyContact: John MeiTaking people
- Klinik fur Innere Medizin IV - Hamatologie/Onkologie, Universitatsklinikum HallHalle, GermanyContact: John MeiTaking 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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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:.