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Completed

NCT Number: NCT02953704

Myelofibrosis and Essential Thrombocythemia Observational Study (MOST)

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).

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Key information

Conditions

MPN (Myeloproliferative Neoplasms) Blood Coagulation Disorders Blood Platelet Disorders Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Myeloproliferative Disorders Primary Myelofibrosis Thrombocythemia, Essential Thrombocytosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bayamón, Puerto Rico

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).
  • Willing and able to provide written informed consent.
  • Willing and able to complete patient assessment questionnaires either alone or with minimal assistance from a caregiver and/or trained site personnel.
  • Under the supervision of a physician for the current care of MF or ET.

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.
  • Life expectancy ≤ 6 months.
  • Diagnosis of secondary acute myeloid leukemia, myelodysplastic syndrome, chronic myelogenous leukemia, or secondary thrombocytosis.

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Description of disease progression over time

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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. Description of reasons for patient ineligibility based on Dynamic International Prognostic Scoring System (DIPSS) during screening (MF patients only)

    Time frame: At screening

  9. 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.

Sponsors and collaborators

Lead sponsor

Incyte Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Nov 3, 2016
Registry last updated
May 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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