Phase
Condition
Warts
Myelofibrosis
Post-polycythemia Vera Myelofibrosis
Treatment
Placebo
TL-895
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 treatingphysician 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 -7to 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 < 50x 10^9/L
Exclusion
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 studytreatment Cohort 5 Key Inclusion Criteria:
- Adults ≥18 years of age
- Confirmed diagnosis of ISM as defined by WHO diagnostic criteria based on review ofbone 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 Design
Connect with a study center
Icon Cancer Centre South Brisbane
South Brisbane, Queensland 4101
AustraliaSite Not Available
Border Medical Oncology
East Albury,
AustraliaCompleted
Southern Oncology Specialists
Kogarah, 2217
AustraliaCompleted
South Eastern Private Hospital
Noble Park,
AustraliaSite Not Available
Royal Perth Hospital
Perth, 6000
AustraliaActive - Recruiting
St Vincent's Hospital Sydney
Sydney, 2010
AustraliaActive - Recruiting
Chu De Liège
Liège, 4000
BelgiumActive - Recruiting
Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, 1200
BelgiumSite Not Available
Hospital de Clinicas de Porto Alegre
Porto Alegre, 90035
BrazilSite Not Available
Hematologista e Pesquisadora Clínica Hospital A Beneficência Portugues
São Paulo, 01323
BrazilActive - Recruiting
Instituto de Estudos e Pesquisas Sao Lucas - IEP - Sao Lucas
São Paulo, 76805
BrazilCompleted
Universidade de Sao Paulo - Hospital das Clinicas da Faculdade de Medicina
São Paulo, 05403
BrazilActive - Recruiting
Dr. Georgi Stranski University Hospital
Pleven, 5809
BulgariaSite Not Available
Military Medical Academy
Sofia,
BulgariaSite Not Available
National Specialized Hospital for Active Treatment of Hematological Diseases
Sofia, 1756
BulgariaActive - Recruiting
University Hospital "St Ivan Rilski"
Sofia, 1431
BulgariaCompleted
CHRU de Brest - Hôpital Morvan
Brest, 29200
FranceSite Not Available
CH Le Mans
Le Mans, 72037
FranceSite Not Available
CHU de Nantes - Hôtel-Dieu
Nantes, 44000
FranceCompleted
CHU de Nice - Hopital L' Archet II
Nice, 06200
FranceCompleted
Hôpital Saint-Louis AP-HP
Paris, 75010
FranceSite Not Available
Universitaetsklinikum Carl Gustav Carus Dresden
Dresden, 01307
GermanyActive - Recruiting
Marien Hospital Duesseldorf
Düsseldorf, 40479
GermanyCompleted
Klinik fur Innere Medizin IV - Hamatologie/Onkologie, Universitatsklinikum Hall
Halle, 07747
GermanyActive - Recruiting
Universitaetsklinikum Jena
Jena, 07743
GermanyActive - Recruiting
Praxisklinik fur Hamatologie und Onkologie
Koblenz, 56073
GermanyCompleted
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032
HungaryCompleted
Markhot Ferenc Oktatokorhaz es Rendelointezet
Eger, 3300
HungaryCompleted
Petz Aladar Egyetemi Oktato Korhaz
Győr, 9024
HungarySite Not Available
Somogy Megyei Kaposi Mor Oktato Korhaz
Kaposvár, 7400
HungarySite Not Available
Szabolcs-Szatmár-Bereg Megyei Önkormányzat Jósa András Oktatókórház Megyei-Városi Tüdőgondozó Intézete
Nyíregyháza, 4400
HungaryCompleted
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
Székesfehérvár, 8000
HungaryCompleted
S. Orsola-Malpighi Polyclinic
Bologna, 40138
ItalySite Not Available
Azienda Ospedaliero Universitaria Policlinico G. Rodolico-San Marco - Presidio Ospedaliero G. Rodolico
Catania, 95123
ItalySite Not Available
Presidio Ospedaliero Gaspare Rodolico
Catania, 95125
ItalyActive - Recruiting
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori
Meldola, 47014
ItalySite Not Available
ASST Grande Ospedale Metropolitano Niguarda
Milano, 20162
ItalySite Not Available
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano
Milano, 20122
ItalySite Not Available
Azienda Ospedaliero Universitaria Maggiore Della Carita'
Novara, 28100
ItalySite Not Available
Azienda Ospedaliera di Perugia-Ospedale S. Maria della Misericordia
Perugia, 06129
ItalySite Not Available
AUSL della Romagna-Ospedale S.Maria delle Croci
Ravenna, 48121
ItalySite Not Available
Grande Ospedale Metropolitano Bianchi Melacrino Morelli
Reggio Calabria, 89124
ItalySite Not Available
Azienda Ospedaliero Universitaria Policlinico Umberto I
Roma, 00161
ItalySite Not Available
Ospedale dell'Angelo
Venezia, 30174
ItalySite Not Available
Kyungpook National University Hospital
Daegu,
Korea, Republic ofCompleted
Asan Medical Center
Seoul,
Korea, Republic ofActive - Recruiting
Samsung Medical Center
Seoul,
Korea, Republic ofActive - Recruiting
Seoul National University Hospital
Seoul,
Korea, Republic ofCompleted
Seoul St. Mary's Hospital, The Catholic University of Korea
Seoul,
Korea, Republic ofCompleted
Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy, Klinika Hematologi
Bydgoszcz, 85-168
PolandSite Not Available
Uniwersyteckie Centrum Kliniczne, Klinika Hematologii i Transplantologii
Gdańsk, 80-211
PolandSite Not Available
Klinika Hematologii Collegium Medicum Uniwersytetu Jagiellonskiego
Kraków, 31-501
PolandSite Not Available
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu, Klinika Hematologii, Nowotworów Krwi i Transplantacji Szpiku
Wrocław, 52-007
PolandActive - Recruiting
Hospital Germans Trias i Pujol
Barcelona, 08916
SpainActive - Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
SpainActive - Recruiting
Institut Catala d'Oncologia - L'Hospitalet
Barcelona, 08908
SpainActive - Recruiting
Hospital Universitari Arnau de Vilanova
Lleida, 25198
SpainSite Not Available
Hospital Universitario 12 de Octubre
Madrid, 28041
SpainActive - Recruiting
Hospital Universitario Virgen de la Victoria
Málaga, 29010
SpainSite Not Available
Salamanca University Hospital
Salamanca, 37007
SpainCompleted
Hospital Quirónsalud Zaragoza
Zaragoza, 50006
SpainActive - Recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)
Kaohsiung, 80756
TaiwanSite Not Available
Chang Gung Memorial Hospital - Kaohsiung Branch
Kaohsiung City,
TaiwanCompleted
China Medical University Hospital
Taichung, 404
TaiwanCompleted
National Taiwan University Hospital
Taipei,
TaiwanCompleted
University of Colorado - Aurora Cancer Center
Aurora, Colorado 80045
United StatesCompleted
University of Maryland
Baltimore, Maryland 21201
United StatesSite Not Available
Revive Research Institute - Royal Oak
Southfield, Michigan 48034
United StatesSite Not Available
Revive Research Institute - Sterling Heights
Sterling Heights, Michigan 48126
United StatesSite Not Available
Mayo Clinic - Rochester
Rochester, Minnesota 55905
United StatesActive - Recruiting
Gabrail Cancer Center
Canton, Ohio 44718
United StatesCompleted
University of Cincinnati (UC) Physicians Company, LLC
Cincinnati, Ohio 45267
United StatesSite Not Available
Ohio State University
Columbus, Ohio 43210
United StatesSite Not Available
University of Texas, MD Anderson Cancer Center
Houston, Texas 77030
United StatesActive - Recruiting
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