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Myelofibrosis and Essential Thrombocythemia Observational Study (MOST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date November 1, 2016
First Posted Date November 3, 2016
Last Update Posted Date May 13, 2022
Actual Study Start Date December 31, 2016
Actual Primary Completion Date March 29, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 1, 2016)
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 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: November 1, 2016)
  • 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 ]
  • Description of disease progression over time [ Time Frame: 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Description of reasons for patient ineligibility based on Dynamic International Prognostic Scoring System (DIPSS) during screening (MF patients only) [ Time Frame: 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. ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Myelofibrosis and Essential Thrombocythemia Observational Study (MOST)
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
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).
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Subjects will be enrolled from up to 250 community and academic centers across the United States.
Condition MPN (Myeloproliferative Neoplasms)
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 11, 2022)
1469
Original Estimated Enrollment
 (submitted: November 1, 2016)
1500
Actual Study Completion Date March 29, 2022
Actual Primary Completion Date March 29, 2022   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02953704
Other Study ID Numbers INCB-MA-MF-401
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Incyte Corporation
Study Sponsor Incyte Corporation
Collaborators Not Provided
Investigators
Study Director: Robyn M. Scherber, MD, MPH Incyte Corporation
PRS Account Incyte Corporation
Verification Date May 2022