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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02953704
Other study ID # INCB-MA-MF-401
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 31, 2016
Est. completion date March 29, 2022

Study information

Verified date May 2022
Source Incyte Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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).


Recruitment information / eligibility

Status Completed
Enrollment 1469
Est. completion date March 29, 2022
Est. primary completion date March 29, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Incyte Corporation

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type Measure Description Time frame Safety issue
Primary Description of the clinical characteristics and evolution of disease burden in essential thrombocythemia (ET) and myelofibrosis (MF) patients Approximately every 6 months through end of study, up to approximately 36 months
Secondary Description of patterns of treatment, therapies, and clinical management Approximately every 3-6 months through end of study, up to at least 36 months
Secondary Description of disease progression over time Approximately every 3-6 months through end of study, up to at least 36 months
Secondary Describe hematocrit, hemoglobin, white blood cell (WBC) count, and platelet counts over time Approximately every 3-6 months through end of study, up to at least 36 months
Secondary Description of the comorbidities associated with disease and progression Approximately every 3-6 months through end of study, up to at least 36 months
Secondary Description of changes in patient-reported symptoms and quality of life (QOL) Approximately every 3-6 months through end of study, up to at least 36 months
Secondary Description of the rate and time to leukemic transformation Approximately every 3-6 months through end of study, up to at least 36 months
Secondary Description of rate of all-cause mortality and aggregate causes of mortality Approximately every 3-6 months through end of study, up to at least 36 months
Secondary Description of reasons for patient ineligibility based on Dynamic International Prognostic Scoring System (DIPSS) during screening (MF patients only) At screening
Secondary Description of time to first disease-related intervention or first progression event during the period of observation (MF patients only) Baseline to end of study, up to 36 months.
See also
  Status Clinical Trial Phase
Terminated NCT03123588 - Phase 2 Study of Ruxolitinib Versus Anagrelide in Subjects With Essential Thrombocythemia Who Are Resistant to or Intolerant of Hydroxyurea (RESET-272) Phase 2
Completed NCT01348490 - Ruxolitinib (INCB018424) in Participants With Primary Myelofibrosis (PMF), Post Essential Thrombocythemia-myelofibrosis and Post Polycythemia Vera-myelofibrosis (PPV-MF) Phase 2
Completed NCT02252159 - Prospective Observational Study Of Patients With Polycythemia Vera In US Clinical Practices (REVEAL)
Completed NCT01633372 - An Open Label Study of Itacitinib Administered Orally in Patients With Myelofibrosis Phase 2
Completed NCT03144687 - A Study of Itacitinib in Combination With Low-Dose Ruxolitinib or Itacitinib Alone Following Ruxolitinib in Participants With Myelofibrosis Phase 2
Terminated NCT02718300 - A Study of INCB050465 in Combination With Ruxolitinib in Subjects With Myelofibrosis Phase 2
Completed NCT00952289 - COntrolled MyeloFibrosis Study With ORal JAK Inhibitor Treatment: The COMFORT-I Trial Phase 3
Active, not recruiting NCT03011372 - A Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Myeloid/Lymphoid Neoplasms With FGFR1 Rearrangement - (FIGHT-203) Phase 2