Myeloproliferative Neoplasms Clinical Trial

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

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 Post ET MF) who are JAKi treatment-naïve or those who have a suboptimal response to ruxolitinib.

View Eligibility Criteria

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

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 1

Estimated Enrollment:

70

Study ID:

NCT05280509

Recruitment Status:

Recruiting

Sponsor:

Telios Pharma, Inc.

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There are 18 Locations for this study

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University of Alabama at Birmingham
Birmingham Alabama, 35294, United States
Gabrail Cancer Center
Canton Ohio, 44718, United States
University of Cincinnati (UC)
Cincinnati Ohio, 45267, United States
The University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States
CHU Angers
Angers , 49100, France
AP-HM - Hôpital de la Timone
Marseille , 13005, France
CHU de Nice - Hopital L'Archet II
Nice , 06200, France
Hôpital Saint Louis - AP-HP
Paris , 75010, France
Centre Hospitalier Lyon Sud
Pierre-Bénite , 69495, France
Marien Hospital Duesseldorf
Düsseldorf , 40479, Germany
Klinik fur Innere Medizin IV - Hamatologie/Onkologie, Universitatsklinikum Hall
Halle , 40479, Germany
IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola
Bologna , 40138, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano
Milano , 20122, Italy
Azienda Ospedaliera di Perugia-Ospedale S. Maria della Misericordia
Perugia , 06129, Italy
Pratia Onkologia Katowice
Katowice , 40-51, Poland
Hospital Universitari Arnau de Vilanova
Lleida , 25198, Spain
Hospital Universitario Ramon y Cajal
Madrid , 28034, Spain
Hospital Universitario Virgen de la Victoria
Málaga , 29010, Spain
Hospital Quironsalud de Zaragoza
Zaragoza , 50006, Spain

How clear is this clinincal trial information?

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 1

Estimated Enrollment:

70

Study ID:

NCT05280509

Recruitment Status:

Recruiting

Sponsor:


Telios Pharma, Inc.

How clear is this clinincal trial information?

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