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