Study of TL-895 in Subjects With Myelofibrosis or Indolent Systemic Mastocytosis
NCT ID: NCT04655118
Last Updated: 2024-05-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
121 participants
INTERVENTIONAL
2020-10-22
2025-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of TL-895 Combined With Ruxolitinib in JAKi Treatment-Naïve MF Subjects and Subjects With MF Who Have a Suboptimal Response to Ruxolitinib
NCT05280509
Study of KRT-232 or TL-895 in Janus Associated Kinase Inhibitor Treatment-Naïve Myelofibrosis
NCT04878003
A Study to Evaluate Safety and Efficacy of Panobinostat in Participants With Primary Myelofibrosis
NCT00931762
To Evaluate Efficacy and Safety of Parsaclisib and Ruxolitinib in Participants With Myelofibrosis Who Have Suboptimal Response to Ruxolitinib (LIMBER-304)
NCT04551053
A Phase 1/2 Study of Oral SB1518 in Subjects With Chronic Idiopathic Myelofibrosis
NCT00745550
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cohort 1a, Relapsed/Refractory Myelofibrosis
150 mg of TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle.
TL-895
TL-895 is an experimental tyrosine kinase inhibitor drug taken by mouth.
Cohort 1b, Relapsed/Refractory Myelofibrosis
300 mg of TL-895 will be administered orally, once daily (QD) continuously starting on Day 1 in a 28-day cycle.
TL-895
TL-895 is an experimental tyrosine kinase inhibitor drug taken by mouth.
Cohort 1c, Relapsed/Refractory Myelofibrosis
300 mg of TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle.
TL-895
TL-895 is an experimental tyrosine kinase inhibitor drug taken by mouth.
Cohort 1d, Relapsed/Refractory Myelofibrosis
450 mg of TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle.
TL-895
TL-895 is an experimental tyrosine kinase inhibitor drug taken by mouth.
Cohort 2a, JAKi Intolerant Myelofibrosis
150 mg of TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle.
TL-895
TL-895 is an experimental tyrosine kinase inhibitor drug taken by mouth.
Cohort 2b, JAKi Intolerant Myelofibrosis
300 mg of TL-895 will be administered orally, once daily (QD) continuously starting on Day 1 in a 28-day cycle.
TL-895
TL-895 is an experimental tyrosine kinase inhibitor drug taken by mouth.
Cohort 3a, JAKi Ineligible Myelofibrosis with platelet count of ≥ 25 and < 50 × 109/L
150 mg of TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle.
TL-895
TL-895 is an experimental tyrosine kinase inhibitor drug taken by mouth.
Cohort 3b, JAKi Ineligible Myelofibrosis with platelet count of ≥ 25 and < 50 × 109/L
300 mg of TL-895 will be administered orally, once daily (QD) continuously starting on Day 1 in a 28-day cycle.
TL-895
TL-895 is an experimental tyrosine kinase inhibitor drug taken by mouth.
Cohort 5a, Indolent Systemic Mastocytosis
TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle in combination with best supportive care (BSC).
TL-895
TL-895 is an experimental tyrosine kinase inhibitor drug taken by mouth.
Cohort 5b, Indolent Systemic Mastocytosis
TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle in combination with BSC.
TL-895
TL-895 is an experimental tyrosine kinase inhibitor drug taken by mouth.
Cohort 5c, Indolent Systemic Mastocytosis
TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle in combination with BSC.
TL-895
TL-895 is an experimental tyrosine kinase inhibitor drug taken by mouth.
Cohort 5d, Indolent Systemic Mastocytosis
TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle in combination with BSC.
TL-895
TL-895 is an experimental tyrosine kinase inhibitor drug taken by mouth.
Cohort 5e, Indolent Systemic Mastocytosis
Placebo to match TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle in combination with BSC.
Placebo
Placebo to match TL-895
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
TL-895
TL-895 is an experimental tyrosine kinase inhibitor drug taken by mouth.
Placebo
Placebo to match TL-895
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
Exclusion Criteria
* 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
* Prior treatment with any BTK or BMX inhibitors
* Prior treatment with Avapritinib, bezuclastinib, or BLU-263/elenestinib
* Diagnosis with another myeloproliferative disorder
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Telios Pharma, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Colorado - Aurora Cancer Center
Aurora, Colorado, United States
Mayo Clinic - Rochester
Rochester, Minnesota, United States
Gabrail Cancer Center
Canton, Ohio, United States
University of Cincinnati (UC) Physicians Company, LLC
Cincinnati, Ohio, United States
Ohio State University
Columbus, Ohio, United States
University of Texas, MD Anderson Cancer Center
Houston, Texas, United States
Border Medical Oncology
East Albury, , Australia
Southern Oncology Specialists
Kogarah, , Australia
Royal Perth Hospital
Perth, , Australia
St Vincent's Hospital Sydney
Sydney, , Australia
Chu De Liège
Liège, , Belgium
Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, , Belgium
Instituto de Estudos e Pesquisas Sao Lucas - IEP - Sao Lucas
São Paulo, , Brazil
University Hospital "St Ivan Rilski"
Sofia, , Bulgaria
Military Medical Academy
Sofia, , Bulgaria
CH Le Mans
Le Mans, , France
CHU de Nantes - Hôtel-Dieu
Nantes, , France
CHU de Nice - Hopital L' Archet II
Nice, , France
Universitaetsklinikum Carl Gustav Carus Dresden
Dresden, , Germany
Marien Hospital Duesseldorf
Düsseldorf, , Germany
Klinik fur Innere Medizin IV - Hamatologie/Onkologie, Universitatsklinikum Hall
Halle, , Germany
Universitaetsklinikum Jena
Jena, , Germany
Praxisklinik fur Hamatologie und Onkologie
Koblenz, , Germany
Debreceni Egyetem Klinikai Kozpont
Debrecen, , Hungary
Markhot Ferenc Oktatokorhaz es Rendelointezet
Eger, , Hungary
Szabolcs-Szatmár-Bereg Megyei Önkormányzat Jósa András Oktatókórház Megyei-Városi Tüdőgondozó Intézete
Nyíregyháza, , Hungary
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
Székesfehérvár, , Hungary
Azienda Ospedaliero Universitaria Policlinico G. Rodolico-San Marco - Presidio Ospedaliero G. Rodolico
Catania, , Italy
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori
Meldola, , Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano
Milan, , Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, , Italy
Azienda Ospedaliero Universitaria Maggiore Della Carita'
Novara, , Italy
Azienda Ospedaliera di Perugia-Ospedale S. Maria della Misericordia
Perugia, , Italy
AUSL della Romagna-Ospedale S.Maria delle Croci
Ravenna, , Italy
Grande Ospedale Metropolitano Bianchi Melacrino Morelli
Reggio Calabria, , Italy
Azienda Ospedaliero Universitaria Policlinico Umberto I
Roma, , Italy
Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy, Klinika Hematologi
Bydgoszcz, , Poland
Uniwersyteckie Centrum Kliniczne, Klinika Hematologii i Transplantologii
Gdansk, , Poland
Klinika Hematologii Collegium Medicum Uniwersytetu Jagiellonskiego
Krakow, , Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu, Klinika Hematologii, Nowotworów Krwi i Transplantacji Szpiku
Wroclaw, , Poland
Kyungpook National University Hospital
Daegu, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Seoul St. Mary's Hospital, The Catholic University of Korea
Seoul, , South Korea
Institut Catala d'Oncologia - L'Hospitalet
Barcelona, , Spain
Hospital Germans Trias i Pujol
Barcelona, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Salamanca University Hospital
Salamanca, , Spain
Hospital Quirónsalud Zaragoza
Zaragoza, , Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)
Kaohsiung City, , Taiwan
Chang Gung Memorial Hospital - Kaohsiung Branch
Kaohsiung City, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TL-895-201
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.