Study of TL-895 in Subjects With Myelofibrosis
Myelofibrosis

About this trial
This is an interventional treatment trial for Myelofibrosis
Eligibility Criteria
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
 - Palpable spleen measuring ≥5 cm below the LLCM or spleen volume of ≥450 cm³ by MRI or CT scan assessment
 - Eastern Cooperative Oncology Group (ECOG) performance status of ≤2
 - Adequate hematologic, hepatic, and renal functions
 
Exclusion Criteria:
- Prior treatment with any BTK or BMX inhibitors
 - Cohorts 1 and 2 - Prior treatment with JAKi within 21 days of the Screening MRI/CT scan. Subjects in Cohort 3 must not have received JAKi
 - Prior splenectomy or splenic irradiation within 24 weeks prior to first dose of study treatment
 
Sites / Locations
- University of Colorado - Aurora Cancer CenterRecruiting
 - University of MarylandRecruiting
 - Gabrail Cancer CenterRecruiting
 - University of Cincinnati (UC) Physicians Company, LLCRecruiting
 - Ohio State UniversityRecruiting
 - University of Texas, MD Anderson Cancer CenterRecruiting
 - Border Medical OncologyRecruiting
 - Southern Oncology SpecialistsRecruiting
 - South Eastern Private HospitalRecruiting
 - Royal Perth HospitalRecruiting
 - St Vincent's Hospital SydneyRecruiting
 - Chu De LiègeRecruiting
 - Cliniques Universitaires Saint-LucRecruiting
 - Hospital de Clinicas de Porto AlegreRecruiting
 - Hematologista e Pesquisadora Clínica Hospital A Beneficência PortuguesRecruiting
 - Universidade de Sao Paulo - Hospital das Clinicas da Faculdade de MedicinaRecruiting
 - Instituto de Estudos e Pesquisas Sao Lucas - IEP - Sao LucasRecruiting
 - University Hospital "St Ivan Rilski"Recruiting
 - National Specialized Hospital for Active Treatment of Hematological DiseasesRecruiting
 - CHRU de Brest - Hôpital MorvanRecruiting
 - CH Le MansRecruiting
 - CHU de Nantes - Hôtel-DieuRecruiting
 - CHU de Nice - Hopital L' Archet IIRecruiting
 - Hôpital Saint-Louis AP-HPRecruiting
 - Universitaetsklinikum Carl Gustav Carus DresdenRecruiting
 - Marien Hospital DuesseldorfRecruiting
 - Klinik fur Innere Medizin IV - Hamatologie/Onkologie, Universitatsklinikum HallRecruiting
 - Universitaetsklinikum JenaRecruiting
 - Praxisklinik fur Hamatologie und OnkologieRecruiting
 - Debreceni Egyetem Klinikai KozpontRecruiting
 - Markhot Ferenc Oktatokorhaz es RendelointezetRecruiting
 - Petz Aladar Egyetemi Oktato KorhazRecruiting
 - Somogy Megyei Kaposi Mor Oktato KorhazRecruiting
 - Szabolcs-Szatmár-Bereg Megyei Önkormányzat Jósa András Oktatókórház Megyei-Városi Tüdőgondozó IntézeteRecruiting
 - Fejer Megyei Szent Gyorgy Egyetemi Oktato KorhazRecruiting
 - Azienda Ospedaliero Universitaria Policlinico G. Rodolico-San Marco - Presidio Ospedaliero G. RodolicoRecruiting
 - Presidio Ospedaliero Gaspare RodolicoRecruiting
 - Istituto Romagnolo per lo Studio dei Tumori Dino AmadoriRecruiting
 - Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di MilanoRecruiting
 - ASST Grande Ospedale Metropolitano NiguardaRecruiting
 - Azienda Ospedaliero Universitaria Maggiore Della Carita'Recruiting
 - Azienda Ospedaliera di Perugia-Ospedale S. Maria della MisericordiaRecruiting
 - AUSL della Romagna-Ospedale S.Maria delle CrociRecruiting
 - Grande Ospedale Metropolitano Bianchi Melacrino MorelliRecruiting
 - Azienda Ospedaliero Universitaria Policlinico Umberto IRecruiting
 - Ospedale dell'AngeloRecruiting
 - Kyungpook National University HospitalRecruiting
 - Asan Medical CenterRecruiting
 - Samsung Medical CenterRecruiting
 - Seoul National University HospitalRecruiting
 - Seoul St. Mary's Hospital, The Catholic University of KoreaRecruiting
 - Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy, Klinika HematologiRecruiting
 - Uniwersyteckie Centrum Kliniczne, Klinika Hematologii i TransplantologiiRecruiting
 - Klinika Hematologii Collegium Medicum Uniwersytetu JagiellonskiegoRecruiting
 - Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu, Klinika Hematologii, Nowotworów Krwi i Transplantacji SzpikuRecruiting
 - Hospital de la Santa Creu i Sant PauRecruiting
 - Institut Catala d'Oncologia - L'HospitaletRecruiting
 - Hospital Germans Trias i PujolRecruiting
 - Hospital Universitari Arnau de VilanovaRecruiting
 - Hospital Universitario 12 de OctubreRecruiting
 - Hospital Universitario Virgen de la VictoriaRecruiting
 - Salamanca University HospitalRecruiting
 - Hospital Quirónsalud ZaragozaRecruiting
 - Chang Gung Memorial Hospital - Kaohsiung BranchRecruiting
 - Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)Recruiting
 - China Medical University HospitalRecruiting
 - National Taiwan University HospitalRecruiting
 
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Cohort 1a, Relapsed/Refractory Myelofibrosis
Cohort 1b, Relapsed/Refractory Myelofibrosis
Cohort 1c, Relapsed/Refractory Myelofibrosis
Cohort 1d, Relapsed/Refractory Myelofibrosis
Cohort 2a, JAKi Intolerant Myelofibrosis
Cohort 2b, JAKi Intolerant Myelofibrosis
Cohort 3a, JAKi Ineligible Myelofibrosis
Cohort 3b, JAKi Ineligible Myelofibrosis
Cohort 1 Expansion, Relapsed/Refractory Myelofibrosis
Cohort 3 Expansion, JAKi Ineligible Myelofibrosis
150 mg of TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle.
300 mg of TL-895 will be administered orally, once daily (QD) continuously starting on Day 1 in a 28-day cycle.
300 mg of TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle.
450 mg of TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle.
150 mg of TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle.
300 mg of TL-895 will be administered orally, once daily (QD) continuously starting on Day 1 in a 28-day cycle.
150 mg of TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle.
300 mg of TL-895 will be administered orally, once daily (QD) continuously starting on Day 1 in a 28-day cycle.
TL-895 administered orally at RP2D and schedule
TL-895 administered orally at RP2D and schedule