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

Recruiting now · Phase 1/Phase 2

Conditions studied: Myelofibrosis, Primary Myelofibrosis, Post-PV MF, Post-ET Myelofibrosis

In brief

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.

Key facts

Study ID

NCT05280509

Run by

Telios Pharma, Inc.

People needed

70

Starts

2022-06-09

Expected to finish

2027-04-01

Last updated by the study team

2023-02-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States (enrolling)
• Gabrail Cancer Center — Canton, Ohio, United States (enrolling)
• University of Cincinnati (UC) — Cincinnati, Ohio, United States (enrolling)
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
• CHU Angers — Angers, France (enrolling)
• AP-HM - Hôpital de la Timone — Marseille, France (enrolling)
• CHU de Nice - Hopital L'Archet II — Nice, France (enrolling)
• Hôpital Saint Louis - AP-HP — Paris, France (enrolling)
• Centre Hospitalier Lyon Sud — Pierre-Bénite, France (enrolling)
• Marien Hospital Duesseldorf — Düsseldorf, Germany (enrolling)
• Klinik fur Innere Medizin IV - Hamatologie/Onkologie, Universitatsklinikum Hall — Halle, Germany (enrolling)
• IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola — Bologna, Italy (enrolling)
• Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano — Milan, Italy (enrolling)
• Azienda Ospedaliera di Perugia-Ospedale S. Maria della Misericordia — Perugia, Italy (enrolling)
• Pratia Onkologia Katowice — Katowice, Poland (enrolling)
• Hospital Universitari Arnau de Vilanova — Lleida, Spain (enrolling)
• Hospital Universitario Ramon y Cajal — Madrid, Spain (enrolling)
• Hospital Universitario Virgen de la Victoria — Málaga, Spain (enrolling)
• Hospital Quironsalud de Zaragoza — Zaragoza, Spain (enrolling)

Full record on ClinicalTrials.gov

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