Myeloproliferative Neoplasms Clinical Trial

Study of TL-895 in Subjects With Myelofibrosis or Indolent Systemic Mastocytosis

Summary

This study evaluates TL-895, a potent, orally-available and highly selective irreversible tyrosine kinase inhibitor for the treatment of Myelofibrosis. Participants must be relapsed/refractory (e.g., having failed prior therapy), intolerant, or ineligible to receive JAKi treatment.

View Eligibility Criteria

Eligibility Criteria

Cohorts 1-3

Key Inclusion Criteria:

Adults ≥18 years of age
Confirmed diagnosis of PMF, post-PV MF, or post-ET MF, as assessed by treating physician according to the World Health Organization (WHO) criteria
Eastern Cooperative Oncology Group (ECOG) performance status of ≤2
Adequate hematologic, hepatic, and renal functions
MF symptoms as defined by having at least 2 symptoms with an average baseline (Day -7 to Day -1) score of at least 1 for each of the 2 symptoms per MFSAF v4.0
Cohort 3 only: Ineligibility for JAKi treatment with a platelet count of ≥ 25 and < 50 x 10^9/L

Key Exclusion Criteria:

Prior treatment with any BTK or BMX inhibitors
Prior treatment with JAKi within 28 days prior to study treatment
Prior splenectomy or splenic irradiation within 24 weeks prior to first dose of study treatment

Cohort 5

Key Inclusion Criteria:

Adults ≥18 years of age
Confirmed diagnosis of ISM as defined by WHO diagnostic criteria based on review of bone marrow biopsy pathology report results
Subject must have moderate-to-severe symptoms

Key Exclusion Criteria:

Prior treatment with any BTK or BMX inhibitors
Prior treatment with Avapritinib, bezuclastinib, or BLU-263/elenestinib
Diagnosis with another myeloproliferative disorder

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 2

Estimated Enrollment:

121

Study ID:

NCT04655118

Recruitment Status:

Recruiting

Sponsor:

Telios Pharma, Inc.

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There are 45 Locations for this study

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University of Colorado - Aurora Cancer Center
Aurora Colorado, 80045, United States
Mayo Clinic - Rochester
Rochester Minnesota, 55905, United States
Gabrail Cancer Center
Canton Ohio, 44718, United States
University of Cincinnati (UC) Physicians Company, LLC
Cincinnati Ohio, 45267, United States
Ohio State University
Columbus Ohio, 43210, United States
University of Texas, MD Anderson Cancer Center
Houston Texas, 77030, United States
Border Medical Oncology
East Albury , , Australia
Southern Oncology Specialists
Kogarah , 2217, Australia
Royal Perth Hospital
Perth , 6000, Australia
St Vincent's Hospital Sydney
Sydney , 2010, Australia
Chu De Liège
Liège , 4000, Belgium
Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert , 1200, Belgium
Instituto de Estudos e Pesquisas Sao Lucas - IEP - Sao Lucas
São Paulo , 76805, Brazil
University Hospital "St Ivan Rilski"
Sofia , 1431, Bulgaria
Military Medical Academy
Sofia , , Bulgaria
CH Le Mans
Le Mans , 72037, France
CHU de Nantes - Hôtel-Dieu
Nantes , 44000, France
CHU de Nice - Hopital L' Archet II
Nice , 06200, France
Universitaetsklinikum Carl Gustav Carus Dresden
Dresden , 01307, Germany
Marien Hospital Duesseldorf
Düsseldorf , 40479, Germany
Klinik fur Innere Medizin IV - Hamatologie/Onkologie, Universitatsklinikum Hall
Halle , 07747, Germany
Universitaetsklinikum Jena
Jena , 07743, Germany
Praxisklinik fur Hamatologie und Onkologie
Koblenz , 56073, Germany
Debreceni Egyetem Klinikai Kozpont
Debrecen , 4032, Hungary
Markhot Ferenc Oktatokorhaz es Rendelointezet
Eger , 3300, Hungary
Szabolcs-Szatmár-Bereg Megyei Önkormányzat Jósa András Oktatókórház Megyei-Városi Tüdőgondozó Intézete
Nyíregyháza , 4400, Hungary
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
Székesfehérvár , 8000, Hungary
Azienda Ospedaliero Universitaria Policlinico G. Rodolico-San Marco - Presidio Ospedaliero G. Rodolico
Catania , 95123, Italy
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori
Meldola , 47014, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano
Milano , 20122, Italy
ASST Grande Ospedale Metropolitano Niguarda
Milano , 20162, Italy
Azienda Ospedaliero Universitaria Maggiore Della Carita'
Novara , 28100, Italy
Azienda Ospedaliera di Perugia-Ospedale S. Maria della Misericordia
Perugia , 06129, Italy
AUSL della Romagna-Ospedale S.Maria delle Croci
Ravenna , 48121, Italy
Grande Ospedale Metropolitano Bianchi Melacrino Morelli
Reggio Calabria , 89124, Italy
Azienda Ospedaliero Universitaria Policlinico Umberto I
Roma , 00161, Italy
Kyungpook National University Hospital
Daegu , , Korea, Republic of
Seoul National University Hospital
Seoul , , Korea, Republic of
Seoul St. Mary's Hospital, The Catholic University of Korea
Seoul , , Korea, Republic of
Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy, Klinika Hematologi
Bydgoszcz , 85-16, Poland
Uniwersyteckie Centrum Kliniczne, Klinika Hematologii i Transplantologii
Gdańsk , 80-21, Poland
Klinika Hematologii Collegium Medicum Uniwersytetu Jagiellonskiego
Kraków , 31-50, Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu, Klinika Hematologii, Nowotworów Krwi i Transplantacji Szpiku
Wrocław , 52-00, Poland
Institut Catala d'Oncologia - L'Hospitalet
Barcelona , 08908, Spain
Hospital Germans Trias i Pujol
Barcelona , 08916, Spain
Hospital Universitario 12 de Octubre
Madrid , 28041, Spain
Salamanca University Hospital
Salamanca , 37007, Spain
Hospital Quirónsalud Zaragoza
Zaragoza , 50006, Spain
Chang Gung Memorial Hospital - Kaohsiung Branch
Kaohsiung City , , Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)
Kaohsiung , 80756, Taiwan
China Medical University Hospital
Taichung , 404, Taiwan
National Taiwan University Hospital
Taipei , , Taiwan

How clear is this clinincal trial information?

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 2

Estimated Enrollment:

121

Study ID:

NCT04655118

Recruitment Status:

Recruiting

Sponsor:


Telios Pharma, Inc.

How clear is this clinincal trial information?

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