Clinical Trial: Myelofibrosis and Essential Thrombocythemia Observational Study (MOST)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Prospective, Longitudinal, Non-Interventional Study of Disease Burden and Treatment of Patients With Low-Risk Myelofibrosis (MF) or High-Risk Essential Thrombocythemia (ET

Brief Summary: The purpose of this prospective, longitudinal, noninterventional study is to describe clinical characteristics, evolution of disease burden, and treatment patterns in patients with select subcategories of essential thrombocythemia (ET) or myelofibrosis (MF).

Detailed Summary:
Sponsor: Incyte Corporation

Current Primary Outcome: Description of the clinical characteristics and evolution of disease burden in essential thrombocythemia (ET) and myelofibrosis (MF) patients [ Time Frame: Approximately every 6 months through end of study, up to approximately 36 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Description of patterns of treatment, therapies, and clinical management [ Time Frame: Approximately every 3-6 months through end of study, up to at least 36 months ]
  • Description of disease progression over time [ Time Frame: Approximately every 3-6 months through end of study, up to at least 36 months ]
  • Describe hematocrit, hemoglobin, white blood cell (WBC) count, and platelet counts over time [ Time Frame: Approximately every 3-6 months through end of study, up to at least 36 months ]
  • Description of the comorbidities associated with disease and progression [ Time Frame: Approximately every 3-6 months through end of study, up to at least 36 months ]
  • Description of changes in patient-reported symptoms and quality of life (QOL) [ Time Frame: Approximately every 3-6 months through end of study, up to at least 36 months ]
  • Description of the rate and time to leukemic transformation [ Time Frame: Approximately every 3-6 months through end of study, up to at least 36 months ]
  • Description of rate of all-cause mortality and aggregate causes of mortality [ Time Frame: Approximately every 3-6 months through end of study, up to at least 36 months ]
  • Description of reasons for patient ineligibility based on Dynamic International Prognostic Scoring System (DIPSS) during screening (MF patients only) [ Time Frame: At screening ]
  • Description of time to first disease-related intervention or first progression event during the period of observation (MF patients only) [ Time Frame: Baseline to end of study, up to 36 months. ]


Original Secondary Outcome: Same as current

Information By: Incyte Corporation

Dates:
Date Received: November 1, 2016
Date Started: December 2016
Date Completion: December 2021
Last Updated: May 1, 2017
Last Verified: May 2017