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Trial record 1 of 1 for:    NCT02953704
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Myelofibrosis and Essential Thrombocythemia Observational Study (MOST)

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ClinicalTrials.gov Identifier: NCT02953704
Recruitment Status : Completed
First Posted : November 3, 2016
Last Update Posted : May 13, 2022
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Study Description
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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).

Condition or disease
MPN (Myeloproliferative Neoplasms)

Study Design
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Study Type : Observational
Actual Enrollment : 1469 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : December 31, 2016
Actual Primary Completion Date : March 29, 2022
Actual Study Completion Date : March 29, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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. ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects will be enrolled from up to 250 community and academic centers across the United States.
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).
  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02953704


Locations
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Sponsors and Collaborators
Incyte Corporation
Investigators
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Study Director: Robyn M. Scherber, MD, MPH Incyte Corporation
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT02953704    
Other Study ID Numbers: INCB-MA-MF-401
First Posted: November 3, 2016    Key Record Dates
Last Update Posted: May 13, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Incyte Corporation:
Myelofibrosis
essential thrombocythemia
clinical characteristics
disease burden
patient-reported outcomes
Additional relevant MeSH terms:
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Primary Myelofibrosis
Myeloproliferative Disorders
Thrombocytosis
Thrombocythemia, Essential
Bone Marrow Diseases
 Hematologic Diseases
Blood Platelet Disorders
Blood Coagulation Disorders
Hemorrhagic Disorders