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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
121
Cohorts 1-3: Determine the RP2D of TL-895
The RP2D for Cohorts 1, 2 and 3 will be reported
Time frame: 9 months
Cohort 5: Determine the RP2D of TL-895
The RP2D for Cohort 5 will be reported
Time frame: Week 24
Cohorts 1-3: Spleen volume reduction (SVR) rate
The proportion of subjects achieving ≥35% SVR at Week 24 by MRI or CT scan (central review).
Time frame: Week 24
Cohort 5: Changes in patient reported symptoms
Mean change in patient reported symptom assessment
Time frame: Week 12
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University of Colorado - Aurora Cancer Center
Aurora, Colorado, United States
COMPLETEDMayo Clinic - Rochester
Rochester, Minnesota, United States
RECRUITINGGabrail Cancer Center
Canton, Ohio, United States
COMPLETEDUniversity of Cincinnati (UC) Physicians Company, LLC
Cincinnati, Ohio, United States
ACTIVE_NOT_RECRUITINGOhio State University
Columbus, Ohio, United States
ACTIVE_NOT_RECRUITINGUniversity of Texas, MD Anderson Cancer Center
Houston, Texas, United States
RECRUITINGBorder Medical Oncology
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COMPLETEDSouthern Oncology Specialists
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COMPLETEDRoyal Perth Hospital
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RECRUITINGSt Vincent's Hospital Sydney
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RECRUITING...and 42 more locations