Myelofibrosis and Essential Thrombocythemia Observational Study (MOST)

May 11, 2022 updated by: Incyte Corporation

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

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).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1469

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • Bayamon, Puerto Rico
      • Ponce, Puerto Rico
  • United States
    • Alabama
      • Huntsville, Alabama, United States
    • Arizona
      • Tempe, Arizona, United States
      • Tucson, Arizona, United States
    • Arkansas
      • Little Rock, Arkansas, United States
    • California
      • Berkeley, California, United States
      • Highland, California, United States
      • Long Beach, California, United States
      • Oceanside, California, United States
      • Palo Alto, California, United States
      • Santa Rosa, California, United States
    • Colorado
      • Aurora, Colorado, United States
      • Colorado Springs, Colorado, United States
      • Fort Collins, Colorado, United States
    • Connecticut
      • Middletown, Connecticut, United States
    • District of Columbia
      • Washington, District of Columbia, United States
    • Florida
      • Aventura, Florida, United States
      • Boynton Beach, Florida, United States
      • Fort Lauderdale, Florida, United States
      • Jacksonville, Florida, United States
      • Pembroke Pines, Florida, United States
      • Tampa, Florida, United States
      • Winter Haven, Florida, United States
    • Georgia
      • Columbus, Georgia, United States
      • Marietta, Georgia, United States
      • Thomasville, Georgia, United States
    • Idaho
      • Boise, Idaho, United States
    • Illinois
      • Chicago, Illinois, United States
      • Elk Grove Village, Illinois, United States
      • Harvey, Illinois, United States
      • Maywood, Illinois, United States
      • Normal, Illinois, United States
      • River Forest, Illinois, United States
      • Skokie, Illinois, United States
    • Indiana
      • Anderson, Indiana, United States
      • Avon, Indiana, United States
      • Indianapolis, Indiana, United States
      • Terre Haute, Indiana, United States
    • Iowa
      • Ames, Iowa, United States
    • Kansas
      • Topeka, Kansas, United States
      • Westwood, Kansas, United States
    • Kentucky
      • Danville, Kentucky, United States
      • Mount Sterling, Kentucky, United States
      • Paducah, Kentucky, United States
    • Louisiana
      • Alexandria, Louisiana, United States
      • Covington, Louisiana, United States
      • Marrero, Louisiana, United States
    • Maine
      • Rockport, Maine, United States
    • Maryland
      • Baltimore, Maryland, United States
      • Bethesda, Maryland, United States
      • Columbia, Maryland, United States
    • Massachusetts
      • Boston, Massachusetts, United States
      • Worcester, Massachusetts, United States
    • Michigan
      • Lansing, Michigan, United States
    • Minnesota
      • Jackson, Minnesota, United States
      • Lansing, Minnesota, United States
    • Missouri
      • Bolivar, Missouri, United States
      • Cape Girardeau, Missouri, United States
      • Jefferson City, Missouri, United States
      • Saint Louis, Missouri, United States
    • Montana
      • Billings, Montana, United States
      • Kalispell, Montana, United States
    • Nebraska
      • Grand Island, Nebraska, United States
      • Omaha, Nebraska, United States
    • Nevada
      • Las Vegas, Nevada, United States
    • New Hampshire
      • Lebanon, New Hampshire, United States
    • New Jersey
      • Brick, New Jersey, United States
      • East Orange, New Jersey, United States
      • Florham Park, New Jersey, United States
      • Morristown, New Jersey, United States
      • Paramus, New Jersey, United States
    • New York
      • Albany, New York, United States
      • Brooklyn, New York, United States
      • East Setauket, New York, United States
      • Elmira, New York, United States
      • New York, New York, United States
      • Rochester, New York, United States
      • Staten Island, New York, United States
    • North Carolina
      • Boone, North Carolina, United States
      • Charlotte, North Carolina, United States
      • Durham, North Carolina, United States
      • Greenville, North Carolina, United States
      • Hendersonville, North Carolina, United States
    • Ohio
      • Canton, Ohio, United States
      • Cincinnati, Ohio, United States
      • Cleveland, Ohio, United States
      • Toledo, Ohio, United States
    • Oregon
      • Tualatin, Oregon, United States
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States
      • Danville, Pennsylvania, United States
      • Dunmore, Pennsylvania, United States
      • Gettysburg, Pennsylvania, United States
      • Pittsburgh, Pennsylvania, United States
      • Willow Grove, Pennsylvania, United States
    • South Carolina
      • Lancaster, South Carolina, United States
      • Spartanburg, South Carolina, United States
    • South Dakota
      • Watertown, South Dakota, United States
    • Tennessee
      • Jackson, Tennessee, United States
    • Texas
      • Amarillo, Texas, United States
      • Arlington, Texas, United States
      • Beaumont, Texas, United States
      • Bryan, Texas, United States
      • Dallas, Texas, United States
      • Houston, Texas, United States
      • McAllen, Texas, United States
      • McKinney, Texas, United States
      • Mesquite, Texas, United States
      • Midland, Texas, United States
      • San Antonio, Texas, United States
      • Wichita Falls, Texas, United States
    • Virginia
      • Bristol, Virginia, United States
    • Washington
      • Seattle, Washington, United States
      • Yakima, Washington, United States
    • West Virginia
      • Martinsburg, West Virginia, United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects will be enrolled from up to 250 community and academic centers across the United States.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Myelofibrosis Cohort
Patients will be categorized as low-risk using Dynamic International Prognostic Scoring System (DIPSS) risk OR intermediate-1 risk by DIPSS by reason of age alone.
Essential Thrombocythemia Cohort
Patients will be age ≥ 60 years OR have history of thromboembolic events OR currently receiving ET-directed therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Approximately every 6 months through end of study, up to approximately 36 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
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
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
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
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
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
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.
Baseline to end of study, up to 36 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Incyte Corporation

Investigators

  • Study Director: Robyn M. Scherber, MD, MPH, Incyte Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 31, 2016

Primary Completion (Actual)

March 29, 2022

Study Completion (Actual)

March 29, 2022

Study Registration Dates

First Submitted

November 1, 2016

First Submitted That Met QC Criteria

November 1, 2016

First Posted (Estimate)

November 3, 2016

Study Record Updates

Last Update Posted (Actual)

May 13, 2022

Last Update Submitted That Met QC Criteria

May 11, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INCB-MA-MF-401

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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