Myeloproliferative neoplasms (MPN)

Myelofibrosis and Essential Thrombocythemia Observational Study (MOST)

Incyte Study ID:
INCB-MA-MF-401
CT.gov ID:
NCT02953704
Eudra ID:
N/A
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
[email protected]
Study Complete
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Clinical Study Purpose

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).

Clinical Study Summary

MEDICAL CONDITION(S)
  • Myeloproliferative neoplasms (MPN)
    • PRODUCT
    COLLABORATORS
    N/A
    DATE
    Dec 2016 - Mar 2022
    TYPE
    Observational
    PHASE
    N/A
    SEX
    Female & Male
    AGE
    18+ years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • MF cohort: Diagnosis of MF and low-risk using DIPSS risk categorization OR intermediate-1 risk by DIPSS by reason of age alone.
    • ET cohort: Diagnosis of ET and age ≥ 60 years OR history of thromboembolic events OR currently receiving ET-directed therapy (eg, hydroxyurea, anagrelide, interferon, busulfan, ruxolitinib, etc).

    Exclusion Criteria

    • Individuals who are participating in blinded investigational drug studies.
    • Individuals who are participating in Incyte investigational/interventional drug trials (company- or investigator-sponsored studies) until they have completed the 30-day end of study visit.

    Clinical Study Locations

    Location
    Status
    Location
    Huntsville, Alabama, US
    Status
    Recruiting
    Location
    Tempe, Arizona, US
    Status
    Recruiting
    Location
    Tucson, Arizona, US
    Status
    Recruiting
    Location
    Little Rock, Arkansas, US
    Status
    Recruiting
    Location
    Berkeley, California, US
    Status
    Recruiting
    Location
    Highland, California, US
    Status
    Recruiting

    Protocol Summary

    Incyte Study ID:
    INCB-MA-MF-401
    Primary Purpose:
    N/A
    Allocation:
    N/A
    Study Design:
    N/A
    Masking:
    N/A
    Interventions:
    N/A
    Enrollment:
    1469
    Primary Outcome
    Open

    Description of the clinical characteristics and evolution of disease burden in essential thrombocythemia (ET) and myelofibrosis (MF) patients

    Timeframe: Approximately every 6 months through end of study, up to approximately 36 months

    Secondary Outcome
    Open

    Description of patterns of treatment, therapies, and clinical management

    Timeframe: Approximately every 3-6 months through end of study, up to at least 36 months

    Description of disease progression over time

    Timeframe: 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

    Timeframe: Approximately every 3-6 months through end of study, up to at least 36 months

    Description of the comorbidities associated with disease and progression

    Timeframe: 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)

    Timeframe: Approximately every 3-6 months through end of study, up to at least 36 months

    Description of the rate and time to leukemic transformation

    Timeframe: 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

    Timeframe: 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)

    Timeframe: At screening

    Description of time to first disease-related intervention or first progression event during the period of observation (MF patients only)

    Timeframe: Baseline to end of study, up to 36 months.