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Trial record 1 of 1 for:    02953704
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Myelofibrosis and Essential Thrombocythemia Observational Study (MOST)

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2017 by Incyte Corporation
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation
ClinicalTrials.gov Identifier:
NCT02953704
First received: November 1, 2016
Last updated: June 7, 2017
Last verified: June 2017
  Purpose
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
Myelofibrosis Essential Thrombocythemia

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Incyte Corporation:

Primary Outcome Measures:
  • 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:
  • 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. ]

Estimated Enrollment: 1500
Study Start Date: December 2016
Estimated Study Completion Date: December 2021
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02953704

Contacts
Contact: Incyte Corporation Call Center 1-844-4-MOSTMPN 1-844-466-7867

  Show 50 Study Locations
Sponsors and Collaborators
Incyte Corporation
Investigators
Study Director: Philomena Colucci, D.O., M.S. Incyte Corporation
  More Information

Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT02953704     History of Changes
Other Study ID Numbers: INCB-MA-MF-401
Study First Received: November 1, 2016
Last Updated: June 7, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Incyte Corporation:
Myelofibrosis
essential thrombocythemia
clinical characteristics
disease burden
patient-reported outcomes

Additional relevant MeSH terms:
Primary Myelofibrosis
Thrombocythemia, Essential
Thrombocytosis
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Blood Coagulation Disorders
Blood Platelet Disorders
Hemorrhagic Disorders

ClinicalTrials.gov processed this record on June 27, 2017