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Study of TL-895 in Subjects With Myelofibrosis or Indolent Systemic Mastocytosis
Trial Status: active
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.
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
Additional locations may be listed on ClinicalTrials.gov for NCT04655118.
Locations matching your search criteria
United States
Arizona
Scottsdale
Mayo Clinic in Arizona
Status: Active
Name Not Available
California
Palo Alto
Stanford Cancer Institute Palo Alto
Status: Active
Name Not Available
Georgia
Atlanta
Emory University Hospital/Winship Cancer Institute
