Myeloproliferative Neoplasms Clinical Trial
Study of TL-895 in Subjects With Myelofibrosis or Indolent Systemic Mastocytosis
Summary
This study evaluates TL-895, a potent, orally-available and highly selective irreversible tyrosine kinase inhibitor for the treatment of Myelofibrosis. Participants must be relapsed/refractory (e.g., having failed prior therapy), intolerant, or ineligible to receive JAKi treatment.
Eligibility Criteria
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 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
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 study treatment
Cohort 5
Key Inclusion Criteria:
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
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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 45 Locations for this study
Aurora Colorado, 80045, United States
Rochester Minnesota, 55905, United States
Canton Ohio, 44718, United States
Cincinnati Ohio, 45267, United States
Columbus Ohio, 43210, United States
Houston Texas, 77030, United States
East Albury , , Australia
Kogarah , 2217, Australia
Perth , 6000, Australia
Sydney , 2010, Australia
Liège , 4000, Belgium
Woluwe-Saint-Lambert , 1200, Belgium
São Paulo , 76805, Brazil
Sofia , 1431, Bulgaria
Sofia , , Bulgaria
Le Mans , 72037, France
Nantes , 44000, France
Nice , 06200, France
Dresden , 01307, Germany
Düsseldorf , 40479, Germany
Halle , 07747, Germany
Jena , 07743, Germany
Koblenz , 56073, Germany
Debrecen , 4032, Hungary
Eger , 3300, Hungary
Nyíregyháza , 4400, Hungary
Székesfehérvár , 8000, Hungary
Catania , 95123, Italy
Meldola , 47014, Italy
Milano , 20122, Italy
Milano , 20162, Italy
Novara , 28100, Italy
Perugia , 06129, Italy
Ravenna , 48121, Italy
Reggio Calabria , 89124, Italy
Roma , 00161, Italy
Daegu , , Korea, Republic of
Seoul , , Korea, Republic of
Seoul , , Korea, Republic of
Bydgoszcz , 85-16, Poland
Gdańsk , 80-21, Poland
Kraków , 31-50, Poland
Wrocław , 52-00, Poland
Barcelona , 08908, Spain
Barcelona , 08916, Spain
Madrid , 28041, Spain
Salamanca , 37007, Spain
Zaragoza , 50006, Spain
Kaohsiung City , , Taiwan
Kaohsiung , 80756, Taiwan
Taichung , 404, Taiwan
Taipei , , Taiwan
How clear is this clinincal trial information?