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MPN (Myeloproliferative Neoplasms)NCT02953704

Myelofibrosis and Essential Thrombocythemia Observational Study (MOST)

An observational study of MPN (Myeloproliferative Neoplasms), run by Incyte Corporation at 116 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
MPN (Myeloproliferative Neoplasms)
How many people
1,469 participants
Where
116 sitesin 2 countries
Study dates
31 Dec 2016to 29 Mar 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

116 sites in 2 countries.

116 sites in 2 countries

United States114 sites

  • Study site

    Albany, New York

  • Study site

    Alexandria, Louisiana

  • Study site

    Amarillo, Texas

  • Study site

    Ames, Iowa

  • Study site

    Anderson, Indiana

  • Study site

    Arlington, Texas

  • Study site

    Aurora, Colorado

  • Study site

    Aventura, Florida

  • Study site

    Avon, Indiana

  • Study site

    Baltimore, Maryland

  • Study site

    Beaumont, Texas

  • Study site

    Berkeley, California

  • Study site

    Bethesda, Maryland

  • Study site

    Bethlehem, Pennsylvania

  • Study site

    Billings, Montana

  • Study site

    Boise, Idaho

  • Study site

    Bolivar, Missouri

  • Study site

    Boone, North Carolina

  • Study site

    Boston, Massachusetts

  • Study site

    Boynton Beach, Florida

  • Study site

    Brick, New Jersey

  • Study site

    Bristol, Virginia

  • Study site

    Brooklyn, New York

  • Study site

    Bryan, Texas

  • Study site

    Canton, Ohio

  • Study site

    Cape Girardeau, Missouri

  • Study site

    Charlotte, North Carolina

  • Study site

    Chicago, Illinois

  • Study site

    Cincinnati, Ohio

  • Study site

    Cleveland, Ohio

  • Study site

    Colorado Springs, Colorado

  • Study site

    Columbia, Maryland

  • Study site

    Columbus, Georgia

  • Study site

    Covington, Louisiana

  • Study site

    Dallas, Texas

  • Study site

    Danville, Kentucky

  • Study site

    Danville, Pennsylvania

  • Study site

    Dunmore, Pennsylvania

  • Study site

    Durham, North Carolina

  • Study site

    East Orange, New Jersey

  • Study site

    East Setauket, New York

  • Study site

    Elk Grove Village, Illinois

  • Study site

    Elmira, New York

  • Study site

    Florham Park, New Jersey

  • Study site

    Fort Collins, Colorado

  • Study site

    Fort Lauderdale, Florida

  • Study site

    Gettysburg, Pennsylvania

  • Study site

    Grand Island, Nebraska

  • Study site

    Greenville, North Carolina

  • Study site

    Harvey, Illinois

  • Study site

    Hendersonville, North Carolina

  • Study site

    Highland, California

  • Study site

    Houston, Texas

  • Study site

    Huntsville, Alabama

  • Study site

    Indianapolis, Indiana

  • Study site

    Jackson, Minnesota

  • Study site

    Jackson, Tennessee

  • Study site

    Jacksonville, Florida

  • Study site

    Jefferson City, Missouri

  • Study site

    Kalispell, Montana

  • Study site

    Lancaster, South Carolina

  • Study site

    Lansing, Michigan

  • Study site

    Lansing, Minnesota

  • Study site

    Las Vegas, Nevada

  • Study site

    Lebanon, New Hampshire

  • Study site

    Little Rock, Arkansas

  • Study site

    Long Beach, California

  • Study site

    Marietta, Georgia

  • Study site

    Marrero, Louisiana

  • Study site

    Martinsburg, West Virginia

  • Study site

    Maywood, Illinois

  • Study site

    McAllen, Texas

  • Study site

    McKinney, Texas

  • Study site

    Mesquite, Texas

  • Study site

    Middletown, Connecticut

  • Study site

    Midland, Texas

  • Study site

    Milwaukee, Wisconsin

  • Study site

    Morristown, New Jersey

  • Study site

    Mount Sterling, Kentucky

  • Study site

    New York, New York

  • Study site

    Normal, Illinois

  • Study site

    Oceanside, California

  • Study site

    Omaha, Nebraska

  • Study site

    Paducah, Kentucky

  • Study site

    Palo Alto, California

  • Study site

    Paramus, New Jersey

  • Study site

    Pembroke Pines, Florida

  • Study site

    Pittsburgh, Pennsylvania

  • Study site

    River Forest, Illinois

  • Study site

    Rochester, New York

  • Study site

    Rockport, Maine

  • Study site

    San Antonio, Texas

  • Study site

    Santa Rosa, California

  • Study site

    Seattle, Washington

  • Study site

    Skokie, Illinois

  • Study site

    Spartanburg, South Carolina

  • Study site

    St Louis, Missouri

  • Study site

    Staten Island, New York

  • Study site

    Tampa, Florida

  • Study site

    Tempe, Arizona

  • Study site

    Terre Haute, Indiana

  • Study site

    Thomasville, Georgia

  • Study site

    Toledo, Ohio

  • Study site

    Topeka, Kansas

  • Study site

    Tualatin, Oregon

  • Study site

    Tucson, Arizona

  • Study site

    Washington D.C., District of Columbia

  • Study site

    Watertown, South Dakota

  • Study site

    Westwood, Kansas

  • Study site

    Wichita Falls, Texas

  • Study site

    Willow Grove, Pennsylvania

  • Study site

    Winter Haven, Florida

  • Study site

    Worcester, Massachusetts

  • Study site

    Yakima, Washington

Other trials in United States

Puerto Rico2 sites

  • Study site

    Bayamón

  • Study site

    Ponce

Other trials in Puerto Rico

About this study

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) 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).

Keywords
Myelofibrosis, essential thrombocythemia, clinical characteristics, disease burden, patient-reported outcomes
Medical subject headings
Myeloproliferative Disorders, Primary Myelofibrosis, Thrombocythemia, Essential

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02953704
Study groupRoleWhat they receive
Myelofibrosis CohortPatients 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 CohortPatients will be age ≥ 60 years OR have history of thromboembolic events OR currently receiving ET-directed therapy.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

Secondary outcomes (9)

  1. Description of patterns of treatment, therapies, and clinical management

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

  2. Description of disease progression over time

    Measured: 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

    Measured: 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

    Measured: 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)

    Measured: 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

    Measured: 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

    Measured: 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)

    Measured: At screening

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Nov 2016 (estimated)
  2. Study start31 Dec 2016
  3. Primary completion29 Mar 2022
  4. Study completion29 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,469 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02953704
Sponsor's protocol ID
INCB-MA-MF-401
Status last verified
May 2022
First submitted
1 Nov 2016
Last updated
13 May 2022
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Ritchie E, Al-Janadi A, Kessler C, Scherber R, Kalafut T, Ren H, Mesa R. Patient-reported outcomes of patients with myelofibrosis or essential thrombocythemia enrolled in the MOST study. Leuk Lymphoma. 2022 Dec;63(13):3138-3153. doi: 10.1080/10428194.2022.2113531. Epub 2022 Oct 7.

    PubMed 36205505

  • Gerds AT, Lyons RM, Colucci P, Kalafut P, Paranagama D, Verstovsek S. Disease and Clinical Characteristics of Patients With a Clinical Diagnosis of Myelofibrosis Enrolled in the MOST Study. Clin Lymphoma Myeloma Leuk. 2022 Jul;22(7):e532-e540. doi: 10.1016/j.clml.2022.02.001. Epub 2022 Feb 8.

    PubMed 35256316

  • Yacoub A, Lyons R, Verstovsek S, Shao R, Chu DT, Agrawal A, Sivaraman S, Colucci P, Paranagama D, Mascarenhas J. Disease and Clinical Characteristics of Patients With a Clinical Diagnosis of Essential Thrombocythemia Enrolled in the MOST Study. Clin Lymphoma Myeloma Leuk. 2021 Jul;21(7):461-469. doi: 10.1016/j.clml.2021.02.011. Epub 2021 Mar 1.

    PubMed 33839074

Questions about this trial

What is this clinical trial studying?

An observational study of MPN (Myeloproliferative Neoplasms), run by Incyte Corporation at 116 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 116 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02953704, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2022.

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