Actively Recruiting
Study of TL-895 in Subjects With Myelofibrosis or Indolent Systemic Mastocytosis
Led by Telios Pharma, Inc. · Updated on 2024-05-10
121
Participants Needed
52
Research Sites
270 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study evaluates TL-895, a potent, orally-available and highly selective irreversible tyrosine kinase inhibitor for the treatment of Myelofibrosis (Cohorts 1-3) or Indolent Systemic Mastocytosis (Cohort 5). Participants must be diagnosed with Myelofibrosis and be relapsed/refractory (e.g., having failed prior therapy), intolerant, or ineligible to receive JAKi treatment, or be diagnosed with Indolent Systemic Mastocytosis.
CONDITIONS
Official Title
Study of TL-895 in Subjects With Myelofibrosis or Indolent Systemic Mastocytosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years of age or older
- Confirmed diagnosis of primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis for Cohorts 1-3
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
- Adequate blood cell counts and liver and kidney function
- Presence of at least 2 myelofibrosis symptoms with an average score of 1 or higher during baseline period
- For Cohort 3 only: Ineligibility for JAK inhibitor treatment with platelet count between 25 and less than 50 x 10^9/L
- Adults 18 years of age or older for Cohort 5
- Confirmed diagnosis of Indolent Systemic Mastocytosis based on bone marrow biopsy per WHO criteria for Cohort 5
- Moderate to severe symptoms for Cohort 5
You will not qualify if you...
- Prior treatment with any BTK or BMX inhibitors
- Prior treatment with JAK inhibitors within 28 days before study treatment for Cohorts 1-3
- Prior splenectomy or splenic irradiation within 24 weeks before first study dose for Cohorts 1-3
- Prior treatment with Avapritinib, bezuclastinib, or BLU-263/elenestinib for Cohort 5
- Diagnosis with another myeloproliferative disorder for Cohort 5
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 52 locations
1
University of Colorado - Aurora Cancer Center
Aurora, Colorado, United States, 80045
Completed
2
Mayo Clinic - Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
3
Gabrail Cancer Center
Canton, Ohio, United States, 44718
Completed
4
University of Cincinnati (UC) Physicians Company, LLC
Cincinnati, Ohio, United States, 45267
Active, Not Recruiting
5
Ohio State University
Columbus, Ohio, United States, 43210
Active, Not Recruiting
6
University of Texas, MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
7
Border Medical Oncology
East Albury, Australia
Completed
8
Southern Oncology Specialists
Kogarah, Australia, 2217
Completed
9
Royal Perth Hospital
Perth, Australia, 6000
Actively Recruiting
10
St Vincent's Hospital Sydney
Sydney, Australia, 2010
Actively Recruiting
11
Chu De Liège
Liège, Belgium, 4000
Actively Recruiting
12
Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, Belgium, 1200
Active, Not Recruiting
13
Instituto de Estudos e Pesquisas Sao Lucas - IEP - Sao Lucas
São Paulo, Brazil, 76805
Completed
14
University Hospital "St Ivan Rilski"
Sofia, Bulgaria, 1431
Completed
15
Military Medical Academy
Sofia, Bulgaria
Active, Not Recruiting
16
CH Le Mans
Le Mans, France, 72037
Active, Not Recruiting
17
CHU de Nantes - Hôtel-Dieu
Nantes, France, 44000
Completed
18
CHU de Nice - Hopital L' Archet II
Nice, France, 06200
Completed
19
Universitaetsklinikum Carl Gustav Carus Dresden
Dresden, Germany, 01307
Actively Recruiting
20
Marien Hospital Duesseldorf
Düsseldorf, Germany, 40479
Completed
21
Klinik fur Innere Medizin IV - Hamatologie/Onkologie, Universitatsklinikum Hall
Halle, Germany, 07747
Actively Recruiting
22
Universitaetsklinikum Jena
Jena, Germany, 07743
Actively Recruiting
23
Praxisklinik fur Hamatologie und Onkologie
Koblenz, Germany, 56073
Completed
24
Debreceni Egyetem Klinikai Kozpont
Debrecen, Hungary, 4032
Completed
25
Markhot Ferenc Oktatokorhaz es Rendelointezet
Eger, Hungary, 3300
Completed
26
Szabolcs-Szatmár-Bereg Megyei Önkormányzat Jósa András Oktatókórház Megyei-Városi Tüdőgondozó Intézete
Nyíregyháza, Hungary, 4400
Completed
27
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
Székesfehérvár, Hungary, 8000
Completed
28
Azienda Ospedaliero Universitaria Policlinico G. Rodolico-San Marco - Presidio Ospedaliero G. Rodolico
Catania, Italy, 95123
Active, Not Recruiting
29
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori
Meldola, Italy, 47014
Active, Not Recruiting
30
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano
Milan, Italy, 20122
Active, Not Recruiting
31
ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy, 20162
Active, Not Recruiting
32
Azienda Ospedaliero Universitaria Maggiore Della Carita'
Novara, Italy, 28100
Active, Not Recruiting
33
Azienda Ospedaliera di Perugia-Ospedale S. Maria della Misericordia
Perugia, Italy, 06129
Active, Not Recruiting
34
AUSL della Romagna-Ospedale S.Maria delle Croci
Ravenna, Italy, 48121
Active, Not Recruiting
35
Grande Ospedale Metropolitano Bianchi Melacrino Morelli
Reggio Calabria, Italy, 89124
Active, Not Recruiting
36
Azienda Ospedaliero Universitaria Policlinico Umberto I
Roma, Italy, 00161
Active, Not Recruiting
37
Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy, Klinika Hematologi
Bydgoszcz, Poland, 85-168
Active, Not Recruiting
38
Uniwersyteckie Centrum Kliniczne, Klinika Hematologii i Transplantologii
Gdansk, Poland, 80-211
Active, Not Recruiting
39
Klinika Hematologii Collegium Medicum Uniwersytetu Jagiellonskiego
Krakow, Poland, 31-501
Not Yet Recruiting
40
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu, Klinika Hematologii, Nowotworów Krwi i Transplantacji Szpiku
Wroclaw, Poland, 52-007
Actively Recruiting
41
Kyungpook National University Hospital
Daegu, South Korea
Completed
42
Seoul National University Hospital
Seoul, South Korea
Completed
43
Seoul St. Mary's Hospital, The Catholic University of Korea
Seoul, South Korea
Completed
44
Institut Catala d'Oncologia - L'Hospitalet
Barcelona, Spain, 08908
Actively Recruiting
45
Hospital Germans Trias i Pujol
Barcelona, Spain, 08916
Actively Recruiting
46
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
47
Salamanca University Hospital
Salamanca, Spain, 37007
Completed
48
Hospital Quirónsalud Zaragoza
Zaragoza, Spain, 50006
Actively Recruiting
49
Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)
Kaohsiung City, Taiwan, 80756
Active, Not Recruiting
50
Chang Gung Memorial Hospital - Kaohsiung Branch
Kaohsiung City, Taiwan
Completed
51
China Medical University Hospital
Taichung, Taiwan, 404
Completed
52
National Taiwan University Hospital
Taipei, Taiwan
Completed
Research Team
J
John Mei
CONTACT
E
Emily Houlihan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
13
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