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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)


Outcome Timeframe 24 weeks

NCTID NCT04878003

Phases PHASE2

Primary Purpose TREATMENT

Start Date 2021-04-13

Completion Date 2024-05

Enrollment Target 52

Interventions

DRUG KRT-232

DRUG TL-895

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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