Myeloproliferative Neoplasms Clinical Trial
Study of KRT-232 or TL-895 in Janus Associated Kinase Inhibitor Treatment-Naïve Myelofibrosis
Summary
This study evaluates either KRT-232 or TL-895 in treatment naïve patients with myelofibrosis (MF)
The study will be conducted in 2 stages. Stage 1 will evaluate safety, tolerability, and efficacy of either KRT-232 (Arm 1) or TL-895 (Arm 2) in treatment naïve patients. Stage 2 will expand enrollment in Arm 1 and/or Arm 2 if expansion criteria is met.
Eligibility Criteria
Inclusion Criteria:
Confirmed diagnosis of PMF, post-PV MF or post-ET MF (WHO)
High-risk, or intermediate-1 and 2 risk, defined by Dynamic International Prognostic System (DIPSS)
ECOG of 0 or 1
Exclusion Criteria:
Subjects who are positive for p53 mutation (Arm 1)
Prior MDM2 inhibitor therapy or p53-directed therapy (Arm 1)
Prior treatment with any JAK inhibitor
Prior splenectomy
Splenic irradiation within 24 weeks prior to randomization
Prior allogeneic stem-cell transplantation or plans for allogeneic stem-cell transplant
History of major organ transplant
Grade 2 or higher QTc prolongation
Major hemorrhage or intracranial hemorrhage within 24 weeks prior to randomization
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There are 27 Locations for this study
Glendale California, 90603, United States
Whittier California, 90603, United States
Canton Ohio, 44718, United States
Houston Texas, 77030, United States
Belarus , 24604, Belarus
Minsk , 22004, Belarus
Pleven , 5800, Bulgaria
Plovdiv , 4000, Bulgaria
Sofia , 1431, Bulgaria
Sofia , 1606, Bulgaria
Sofia , 1756, Bulgaria
Kutaisi , 4600, Georgia
Tbilisi , 112, Georgia
Tbilisi , 159, Georgia
Aguascalientes , 20116, Mexico
Chihuahua , 31200, Mexico
Oaxaca , 68020, Mexico
Veracruz , 91900, Mexico
Katowice , 40-51, Poland
Opole , 45-06, Poland
SÅ‚upsk , 76-20, Poland
Moscow , 12528, Russian Federation
Petrozavodsk , 18501, Russian Federation
Saint Petersburg , 19702, Russian Federation
Saint Petersburg , 19734, Russian Federation
Saint Petersburg , 19734, Russian Federation
Samara , 44309, Russian Federation
Soweto , 1519, South Africa
Dnipro , 49102, Ukraine
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