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An Open-Label, Multicenter, Phase 2 Study Assessing the Safety and Efficacy of KRT-232 or TL-895 in Janus Associated Kinase Inhibitor Treatment-Naïve Myelofibrosis
Description
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.
Trial Eligibility
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
Study Info
Organization
Kartos Therapeutics, Inc.
Primary Outcome
Spleen Volume Reduction (SVR)
Interventions
Locations Recruiting
Innovative Clinical Research Institute
United States, California, Glendale
Innovative Clinical Research Institute
United States, California, Whittier
Gabrail Cancer Center
United States, Ohio, Canton
MD Anderson Cancer Center
United States, Texas, Houston
Republican Scientific Practical Center of Radiation Medicine and Human Ecology
Belarus, Belarus
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