Prospective Observational Study Of Patients With Polycythemia Vera In US Clinical Practices (REVEAL)

April 22, 2021 updated by: Incyte Corporation

Prospective, Non-interventional Study of Disease Progression and Treatment of Patients With Polycythemia Vera in United States Academic or Community Clinical Practices

This is a Phase IV, multicenter, non-interventional, non-randomized, prospective, observational study in an adult population (patients >18 years old) of men and women who have been diagnosed with clinically overt PV and are being followed in either community or academic medical centers in the United States who will be enrolled over a 12-month period and observed for 36 months from the date the last patient is enrolled.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

2544

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • Bayamon, Puerto Rico
      • Ponce, Puerto Rico
  • United States
    • Arizona
      • Green Valley, Arizona, United States
      • Safford, Arizona, United States
      • Scottsdale, Arizona, United States
      • Tucson, Arizona, United States
      • Yuma, Arizona, United States
    • Arkansas
      • Jonesboro, Arkansas, United States
      • Little Rock, Arkansas, United States
      • North Little Rock, Arkansas, United States
      • Stuttgart, Arkansas, United States
    • California
      • Berkeley, California, United States
      • Burbank, California, United States
      • Corona, California, United States
      • Fountain Valley, California, United States
      • Highland, California, United States
      • Laguna Hills, California, United States
      • Los Alamitos, California, United States
      • Oceanside, California, United States
      • Orange, California, United States
      • Pismo Beach, California, United States
      • Rancho Mirage, California, United States
      • Riverside, California, United States
      • Santa Maria, California, United States
      • Santa Rosa, California, United States
      • Tarzana, California, United States
      • Torrance, California, United States
      • Vallejo, California, United States
      • West Hills, California, United States
      • Whittier, California, United States
    • Colorado
      • Aurora, Colorado, United States
      • Colorado Springs, Colorado, United States
      • Fort Collins, Colorado, United States
      • Pueblo, Colorado, United States
    • Connecticut
      • Middletown, Connecticut, United States
      • Norwich, Connecticut, United States
      • Stamford, Connecticut, United States
    • District of Columbia
      • Washington, District of Columbia, United States
    • Florida
      • Aventura, Florida, United States
      • Boynton Beach, Florida, United States
      • Deerfield Beach, Florida, United States
      • Fort Lauderdale, Florida, United States
      • Hialeah, Florida, United States
      • Hollywood, Florida, United States
      • Jacksonville, Florida, United States
      • Miami Lakes, Florida, United States
      • Ocala, Florida, United States
      • Pembroke Pines, Florida, United States
      • Pensacola, Florida, United States
      • Santa Rosa Beach, Florida, United States
      • Winter Haven, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
      • Augusta, Georgia, United States
      • Austell, Georgia, United States
      • Cartersville, Georgia, United States
      • Columbus, Georgia, United States
      • Douglasville, Georgia, United States
      • Gainesville, Georgia, United States
      • Marietta, Georgia, United States
      • Rome, Georgia, United States
      • Savannah, Georgia, United States
      • Thomasville, Georgia, United States
    • Idaho
      • Boise, Idaho, United States
      • Post Falls, Idaho, United States
    • Illinois
      • Berwyn, Illinois, United States
      • Chicago, Illinois, United States
      • Danville, Illinois, United States
      • Decatur, Illinois, United States
      • Effingham, Illinois, United States
      • Evanston, Illinois, United States
      • Harvey, Illinois, United States
      • Joliet, Illinois, United States
      • Kewanee, Illinois, United States
      • Macomb, Illinois, United States
      • Maywood, Illinois, United States
      • Morris, Illinois, United States
      • New Lenox, Illinois, United States
      • Normal, Illinois, United States
      • Ottawa, Illinois, United States
      • Park Ridge, Illinois, United States
      • Pekin, Illinois, United States
      • Peoria, Illinois, United States
      • Peru, Illinois, United States
      • Princeton, Illinois, United States
      • Skokie, Illinois, United States
      • Springfield, Illinois, United States
      • Urbana, Illinois, United States
    • Indiana
      • Anderson, Indiana, United States
      • Columbus, Indiana, United States
      • Crown Point, Indiana, United States
      • Fort Wayne, Indiana, United States
      • Indianapolis, Indiana, United States
      • Lafayette, Indiana, United States
      • Marion, Indiana, United States
      • Mooresville, Indiana, United States
      • New Albany, Indiana, United States
      • Newburgh, Indiana, United States
      • Terre Haute, Indiana, United States
    • Iowa
      • Cedar Rapids, Iowa, United States
      • Iowa City, Iowa, United States
      • Mason City, Iowa, United States
      • Sioux City, Iowa, United States
    • Kansas
      • Topeka, Kansas, United States
      • Wichita, Kansas, United States
    • Kentucky
      • Ashland, Kentucky, United States
      • Danville, Kentucky, United States
      • Hazard, Kentucky, United States
      • Lexington, Kentucky, United States
      • Louisville, Kentucky, United States
      • Mount Sterling, Kentucky, United States
      • Paducah, Kentucky, United States
      • Richmond, Kentucky, United States
    • Louisiana
      • Alexandria, Louisiana, United States
      • Baton Rouge, Louisiana, United States
      • Marrero, Louisiana, United States
      • Shreveport, Louisiana, United States
    • Maine
      • Rockport, Maine, United States
    • Maryland
      • Baltimore, Maryland, United States
      • Bethesda, Maryland, United States
      • Clinton, Maryland, United States
      • Cumberland, Maryland, United States
      • Hagerstown, Maryland, United States
    • Massachusetts
      • Boston, Massachusetts, United States
      • Fairhaven, Massachusetts, United States
      • Lawrence, Massachusetts, United States
      • Pittsfield, Massachusetts, United States
      • Worcester, Massachusetts, United States
    • Michigan
      • Ann Arbor, Michigan, United States
      • Battle Creek, Michigan, United States
      • Brighton, Michigan, United States
      • Canton, Michigan, United States
      • Chelsea, Michigan, United States
      • Dearborn, Michigan, United States
      • Detroit, Michigan, United States
      • Flint, Michigan, United States
      • Grand Rapids, Michigan, United States
      • Jackson, Michigan, United States
      • Kalamazoo, Michigan, United States
      • Lansing, Michigan, United States
      • Marquette, Michigan, United States
      • Pontiac, Michigan, United States
      • Saginaw, Michigan, United States
    • Minnesota
      • Edina, Minnesota, United States
      • Minneapolis, Minnesota, United States
      • Saint Cloud, Minnesota, United States
      • Saint Louis Park, Minnesota, United States
      • Saint Paul, Minnesota, United States
    • Missouri
      • Bolivar, Missouri, United States
      • Cape Girardeau, Missouri, United States
      • Kansas City, Missouri, United States
      • Saint Louis, Missouri, United States
    • Montana
      • Billings, Montana, United States
      • Kalispell, Montana, United States
    • Nevada
      • Henderson, Nevada, United States
      • Las Vegas, Nevada, United States
    • New Hampshire
      • Dover, New Hampshire, United States
      • Portsmouth, New Hampshire, United States
    • New Jersey
      • Brick, New Jersey, United States
      • East Orange, New Jersey, United States
      • Edison, New Jersey, United States
      • Flemington, New Jersey, United States
      • Hackettstown, New Jersey, United States
      • Paramus, New Jersey, United States
      • Somerville, New Jersey, United States
      • Sparta, New Jersey, United States
      • Vineland, New Jersey, United States
    • New Mexico
      • Farmington, New Mexico, United States
    • New York
      • Albany, New York, United States
      • Binghamton, New York, United States
      • Bronx, New York, United States
      • Brooklyn, New York, United States
      • Cooperstown, New York, United States
      • Corning, New York, United States
      • East Setauket, New York, United States
      • Elmira, New York, United States
      • Herkimer, New York, United States
      • Ithaca, New York, United States
      • Johnson City, New York, United States
      • New York, New York, United States
      • Oneonta, New York, United States
      • Poughkeepsie, New York, United States
      • Rochester, New York, United States
      • Staten Island, New York, United States
      • Utica, New York, United States
    • North Carolina
      • Albemarle, North Carolina, United States
      • Boone, North Carolina, United States
      • Charlotte, North Carolina, United States
      • Clayton, North Carolina, United States
      • Durham, North Carolina, United States
      • Greenville, North Carolina, United States
      • Henderson, North Carolina, United States
      • Hendersonville, North Carolina, United States
      • Hickory, North Carolina, United States
      • Lincolnton, North Carolina, United States
      • Shelby, North Carolina, United States
      • Smithfield, North Carolina, United States
      • Winston-Salem, North Carolina, United States
    • North Dakota
      • Bismarck, North Dakota, United States
    • Ohio
      • Canton, Ohio, United States
      • Cincinnati, Ohio, United States
      • Cleveland, Ohio, United States
      • Columbus, Ohio, United States
      • Dover, Ohio, United States
      • Huber Heights, Ohio, United States
      • Massillon, Ohio, United States
      • Mount Vernon, Ohio, United States
      • Oregon, Ohio, United States
      • Toledo, Ohio, United States
      • West Chester, Ohio, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
    • Oregon
      • Beaverton, Oregon, United States
      • Corvallis, Oregon, United States
      • Portland, Oregon, United States
      • Salem, Oregon, United States
    • Pennsylvania
      • Allentown, Pennsylvania, United States
      • Bethlehem, Pennsylvania, United States
      • Broomall, Pennsylvania, United States
      • Drexel Hill, Pennsylvania, United States
      • Easton, Pennsylvania, United States
      • Gettysburg, Pennsylvania, United States
      • Hanover, Pennsylvania, United States
      • Hershey, Pennsylvania, United States
      • Kittanning, Pennsylvania, United States
      • Philadelphia, Pennsylvania, United States
      • Quakertown, Pennsylvania, United States
      • Sayre, Pennsylvania, United States
      • Upland, Pennsylvania, United States
      • Wellsboro, Pennsylvania, United States
      • Willow Grove, Pennsylvania, United States
      • York, Pennsylvania, United States
    • Rhode Island
      • Pawtucket, Rhode Island, United States
    • South Carolina
      • Charleston, South Carolina, United States
      • Hilton Head Island, South Carolina, United States
      • Murrells Inlet, South Carolina, United States
      • Rock Hill, South Carolina, United States
    • South Dakota
      • Rapid City, South Dakota, United States
      • Sioux Falls, South Dakota, United States
      • Watertown, South Dakota, United States
    • Tennessee
      • Germantown, Tennessee, United States
      • Jackson, Tennessee, United States
      • Nashville, Tennessee, United States
    • Texas
      • Abilene, Texas, United States
      • Athens, Texas, United States
      • Bryan, Texas, United States
      • Corpus Christi, Texas, United States
      • Galveston, Texas, United States
      • Houston, Texas, United States
      • Jacksonville, Texas, United States
      • Plano, Texas, United States
      • Richardson, Texas, United States
      • Tyler, Texas, United States
    • Utah
      • Ogden, Utah, United States
      • Salt Lake City, Utah, United States
    • Virginia
      • Bristol, Virginia, United States
      • Chesapeake, Virginia, United States
      • Falls Church, Virginia, United States
      • Portsmouth, Virginia, United States
      • Suffolk, Virginia, United States
    • Washington
      • Bellingham, Washington, United States
      • Everett, Washington, United States
      • Puyallup, Washington, United States
      • Seattle, Washington, United States
    • West Virginia
      • Martinsburg, West Virginia, United States
    • Wisconsin
      • Green Bay, Wisconsin, United States
      • Milwaukee, Wisconsin, United States
      • Weston, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

An adult population (patients >18 years old) of men and women who have been diagnosed with clinically overt PV will be enrolled. Sites will include both community and academic centers across the United States that are representative of where patients with PV are diagnosed and treated.

Description

Inclusion Criteria:

  • Age ≥18 years
  • Diagnosis of Polycythemia Vera (PV)
  • 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 PV including but not limited to watchful waiting, acetylsalicylic acid (ASA) 81mg or greater, antithrombotic therapy, Phlebotomy (PHL), Hydroxyurea (HU), interferon (recombinant or pegylated), busulfan, anagrelide

Exclusion Criteria:

  • Participation in an active clinical trial in which the study treatment is blinded
  • Life expectancy <6 months
  • Diagnosis of myelofibrosis (MF) [including primary MF, post-PV MF, or post-essential thrombocythemia MF (post-ET MF)]
  • Diagnosis of secondary Acute Myeloid Leukemia (AML)
  • Diagnosis of Myelodysplastic Syndrome (MDS)
  • History of or active plan to proceed to allogeneic hematopoietic stem cell transplant in next 3 months
  • Splenectomy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Cohort A

Patients with clinically overt PV (and not exhibiting any of the characteristics listed for Cohort B), managed with:

  1. Watchful waiting (with or without aspirin)*, or
  2. Phlebotomy (PHL) alone (with or without aspirin)* - or
  3. HU alone (without concomitant PHL, with or without aspirin).

(*Unless patient has a history of intolerance or clinical resistance/ refractoriness to hydroxyurea [HU] (as assessed by the treating physician) - in which case, s/he belongs to Cohort B)
Cohort B

Patients with clinically overt PV, with one or more of the following disease characteristics:

  1. Treatment with HU and PHL in combination or
  2. Treatment with any agent other than HU or aspirin (e.g., recombinant interferon (IFN) or pegylated IFN preparations, busulfan, anagrelide) or
  3. A history of thrombosis (venous or arterial) or
  4. A history of intolerance or clinical resistance/ refractoriness to HU (as assessed by the treating physician) or
  5. Presence of documented splenomegaly (clinically assessed by palpation) or

  6. Presence of one or more of the following uncontrolled symptoms related to PV despite therapy (Symptoms deemed uncontrolled as per physician's judgment)

    1. Tiredness
    2. Difficulty sleeping
    3. Itching
    4. Muscle aches and/or bone pain
    5. Night sweats
    6. Sweats while awake
    7. Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Description of patterns of the disease Polycythemia Vera (PV), and associations of such patterns with patients' exposures or treatments
Time Frame: Every 3 months for approximately 36 months
Every 3 months for approximately 36 months
Incidence (frequency) of disease progression
Time Frame: Every 3 months for approximately 36 months
Every 3 months for approximately 36 months
Incidence (frequency) of healthcare resources utilization
Time Frame: Every 3 months for approximately 36 months
Healthcare resources were defined as a. Medical visits (including Office visits, ER visits, and hospitalizations), b. phlebotomy (PHL) procedures and c. prescriptions (including PV-related prescriptions, PV-related over-the-counter (OTC) medications, and prescription medications for co-morbid conditions).
Every 3 months for approximately 36 months
Incidence (frequency) of complications due to PV
Time Frame: Every 3 months for approximately 36 months
Every 3 months for approximately 36 months
Incidence (frequency) and description of PV-related symptoms
Time Frame: Every 3 months for approximately 36 months
Every 3 months for approximately 36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence (frequency) of adverse events (for those patients on active therapies, including PHL)
Time Frame: Baseline through end of study. Approximately 36 months
Baseline through end of study. Approximately 36 months
Patient-reported outcomes as assessed by Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS) for assessment of the severity of symptoms
Time Frame: Every 3 months for approximately 36 months
The MPN-SAF TSS is a validated 10-item instrument that efficiently assesses the prevalence and severity of PV symptoms in both clinical practice and trial settings. Higher scores indicate more severe symptoms and greater inactivity with a possible total score range of 0-100.
Every 3 months for approximately 36 months
Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP) score for assessment of work productivity and activity impairment
Time Frame: Every 3 months for approximately 36 months
WPAI-SHP is a validated 6-item instrument that measures the effect of overall health and specific symptoms on productivity at work and outside of it. All outcomes are presented as a proportion, with 0% representing minimal/no impairment and 100% representing maximal impairment or productivity loss.
Every 3 months for approximately 36 months
European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) for Health Related Quality of Life (HRQoL)
Time Frame: Every 3 months for approximately 36 months
Every 3 months for approximately 36 months
Caregiver burden
Time Frame: Every 3 months for approximately 36 months
The amount of health care received by a paid healthcare worker or by an unpaid caregiver
Every 3 months for approximately 36 months
Burden of phlebotomy (PHL)
Time Frame: Every 3 months for approximately 36 months
A patients self-reported assessment of burden including pain at site, difficulty and inconvenience of scheduling and cost factors.
Every 3 months for approximately 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Incyte Corporation

Investigators

  • Study Director: Robyn M. Scherber, MD, MPH, Incyte Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 31, 2014

Primary Completion (Actual)

August 3, 2019

Study Completion (Actual)

August 3, 2019

Study Registration Dates

First Submitted

September 23, 2014

First Submitted That Met QC Criteria

September 25, 2014

First Posted (Estimate)

September 30, 2014

Study Record Updates

Last Update Posted (Actual)

April 26, 2021

Last Update Submitted That Met QC Criteria

April 22, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INCB-MA-PV-401

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on MPN (Myeloproliferative Neoplasms)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cambodia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe