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MPN (Myeloproliferative Neoplasms)NCT02252159

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

An observational study of MPN (Myeloproliferative Neoplasms), run by Incyte Corporation at 266 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
MPN (Myeloproliferative Neoplasms)
How many people
2,544 participants
Where
266 sitesin 2 countries
Study dates
31 Jul 2014to 3 Aug 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

266 sites in 2 countries.

266 sites in 2 countries

United States264 sites

  • Study site

    Abilene, Texas

  • Study site

    Albany, New York

  • Study site

    Albemarle, North Carolina

  • Study site

    Alexandria, Louisiana

  • Study site

    Allentown, Pennsylvania

  • Study site

    Anderson, Indiana

  • Study site

    Ann Arbor, Michigan

  • Study site

    Ashland, Kentucky

  • Study site

    Athens, Texas

  • Study site

    Atlanta, Georgia

  • Study site

    Augusta, Georgia

  • Study site

    Aurora, Colorado

  • Study site

    Austell, Georgia

  • Study site

    Aventura, Florida

  • Study site

    Baltimore, Maryland

  • Study site

    Baton Rouge, Louisiana

  • Study site

    Battle Creek, Michigan

  • Study site

    Beaverton, Oregon

  • Study site

    Bellingham, Washington

  • Study site

    Berkeley, California

  • Study site

    Berwyn, Illinois

  • Study site

    Bethesda, Maryland

  • Study site

    Bethlehem, Pennsylvania

  • Study site

    Billings, Montana

  • Study site

    Binghamton, New York

  • Study site

    Bismarck, North Dakota

  • Study site

    Boise, Idaho

  • Study site

    Bolivar, Missouri

  • Study site

    Boone, North Carolina

  • Study site

    Boston, Massachusetts

  • Study site

    Boynton Beach, Florida

  • Study site

    Brick, New Jersey

  • Study site

    Brighton, Michigan

  • Study site

    Bristol, Virginia

  • Study site

    Brooklyn, New York

  • Study site

    Broomall, Pennsylvania

  • Study site

    Bryan, Texas

  • Study site

    Burbank, California

  • Study site

    Canton, Michigan

  • Study site

    Canton, Ohio

  • Study site

    Cape Girardeau, Missouri

  • Study site

    Cartersville, Georgia

  • Study site

    Cedar Rapids, Iowa

  • Study site

    Charleston, South Carolina

  • Study site

    Charlotte, North Carolina

  • Study site

    Chelsea, Michigan

  • Study site

    Chesapeake, Virginia

  • Study site

    Chicago, Illinois

  • Study site

    Cincinnati, Ohio

  • Study site

    Clayton, North Carolina

  • Study site

    Cleveland, Ohio

  • Study site

    Clinton, Maryland

  • Study site

    Colorado Springs, Colorado

  • Study site

    Columbus, Georgia

  • Study site

    Columbus, Indiana

  • Study site

    Columbus, Ohio

  • Study site

    Cooperstown, New York

  • Study site

    Corning, New York

  • Study site

    Corona, California

  • Study site

    Corpus Christi, Texas

  • Study site

    Corvallis, Oregon

  • Study site

    Crown Point, Indiana

  • Study site

    Cumberland, Maryland

  • Study site

    Danville, Illinois

  • Study site

    Danville, Kentucky

  • Study site

    Dearborn, Michigan

  • Study site

    Decatur, Illinois

  • Study site

    Deerfield Beach, Florida

  • Study site

    Detroit, Michigan

  • Study site

    Douglasville, Georgia

  • Study site

    Dover, New Hampshire

  • Study site

    Dover, Ohio

  • Study site

    Drexel Hill, Pennsylvania

  • Study site

    Durham, North Carolina

  • Study site

    East Orange, New Jersey

  • Study site

    East Setauket, New York

  • Study site

    Easton, Pennsylvania

  • Study site

    Edina, Minnesota

  • Study site

    Edison, New Jersey

  • Study site

    Effingham, Illinois

  • Study site

    Elmira, New York

  • Study site

    Evanston, Illinois

  • Study site

    Everett, Washington

  • Study site

    Fairhaven, Massachusetts

  • Study site

    Falls Church, Virginia

  • Study site

    Farmington, New Mexico

  • Study site

    Flemington, New Jersey

  • Study site

    Flint, Michigan

  • Study site

    Fort Collins, Colorado

  • Study site

    Fort Lauderdale, Florida

  • Study site

    Fort Wayne, Indiana

  • Study site

    Fountain Valley, California

  • Study site

    Gainesville, Georgia

  • Study site

    Galveston, Texas

  • Study site

    Germantown, Tennessee

  • Study site

    Gettysburg, Pennsylvania

  • Study site

    Grand Rapids, Michigan

  • Study site

    Green Bay, Wisconsin

  • Study site

    Green Valley, Arizona

  • Study site

    Greenville, North Carolina

  • Study site

    Hackettstown, New Jersey

  • Study site

    Hagerstown, Maryland

  • Study site

    Hanover, Pennsylvania

  • Study site

    Harvey, Illinois

  • Study site

    Hazard, Kentucky

  • Study site

    Henderson, Nevada

  • Study site

    Henderson, North Carolina

  • Study site

    Hendersonville, North Carolina

  • Study site

    Herkimer, New York

  • Study site

    Hershey, Pennsylvania

  • Study site

    Hialeah, Florida

  • Study site

    Hickory, North Carolina

  • Study site

    Highland, California

  • Study site

    Hilton Head Island, South Carolina

  • Study site

    Hollywood, Florida

  • Study site

    Houston, Texas

  • Study site

    Huber Heights, Ohio

  • Study site

    Indianapolis, Indiana

  • Study site

    Iowa City, Iowa

  • Study site

    Ithaca, New York

  • Study site

    Jackson, Michigan

  • Study site

    Jackson, Tennessee

  • Study site

    Jacksonville, Florida

  • Study site

    Jacksonville, Texas

  • Study site

    Johnson City, New York

  • Study site

    Joliet, Illinois

  • Study site

    Jonesboro, Arkansas

  • Study site

    Kalamazoo, Michigan

  • Study site

    Kalispell, Montana

  • Study site

    Kansas City, Missouri

  • Study site

    Kewanee, Illinois

  • Study site

    Kittanning, Pennsylvania

  • Study site

    Lafayette, Indiana

  • Study site

    Laguna Hills, California

  • Study site

    Lansing, Michigan

  • Study site

    Las Vegas, Nevada

  • Study site

    Lawrence, Massachusetts

  • Study site

    Lexington, Kentucky

  • Study site

    Lincolnton, North Carolina

  • Study site

    Little Rock, Arkansas

  • Study site

    Los Alamitos, California

  • Study site

    Louisville, Kentucky

  • Study site

    Macomb, Illinois

  • Study site

    Marietta, Georgia

  • Study site

    Marion, Indiana

  • Study site

    Marquette, Michigan

  • Study site

    Marrero, Louisiana

  • Study site

    Martinsburg, West Virginia

  • Study site

    Mason City, Iowa

  • Study site

    Massillon, Ohio

  • Study site

    Maywood, Illinois

  • Study site

    Miami Lakes, Florida

  • Study site

    Middletown, Connecticut

  • Study site

    Milwaukee, Wisconsin

  • Study site

    Minneapolis, Minnesota

  • Study site

    Mooresville, Indiana

  • Study site

    Morris, Illinois

  • Study site

    Mount Sterling, Kentucky

  • Study site

    Mount Vernon, Ohio

  • Study site

    Murrells Inlet, South Carolina

  • Study site

    Nashville, Tennessee

  • Study site

    New Albany, Indiana

  • Study site

    New Lenox, Illinois

  • Study site

    New York, New York

  • Study site

    Newburgh, Indiana

  • Study site

    Normal, Illinois

  • Study site

    North Little Rock, Arkansas

  • Study site

    Norwich, Connecticut

  • Study site

    Ocala, Florida

  • Study site

    Oceanside, California

  • Study site

    Ogden, Utah

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Oneonta, New York

  • Study site

    Orange, California

  • Study site

    Oregon, Ohio

  • Study site

    Ottawa, Illinois

  • Study site

    Paducah, Kentucky

  • Study site

    Paramus, New Jersey

  • Study site

    Park Ridge, Illinois

  • Study site

    Pawtucket, Rhode Island

  • Study site

    Pekin, Illinois

  • Study site

    Pembroke Pines, Florida

  • Study site

    Pensacola, Florida

  • Study site

    Peoria, Illinois

  • Study site

    Peru, Illinois

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Pismo Beach, California

  • Study site

    Pittsfield, Massachusetts

  • Study site

    Plano, Texas

  • Study site

    Pontiac, Michigan

  • Study site

    Portland, Oregon

  • Study site

    Portsmouth, New Hampshire

  • Study site

    Portsmouth, Virginia

  • Study site

    Post Falls, Idaho

  • Study site

    Poughkeepsie, New York

  • Study site

    Princeton, Illinois

  • Study site

    Pueblo, Colorado

  • Study site

    Puyallup, Washington

  • Study site

    Quakertown, Pennsylvania

  • Study site

    Rancho Mirage, California

  • Study site

    Rapid City, South Dakota

  • Study site

    Richardson, Texas

  • Study site

    Richmond, Kentucky

  • Study site

    Riverside, California

  • Study site

    Rochester, New York

  • Study site

    Rock Hill, South Carolina

  • Study site

    Rockport, Maine

  • Study site

    Rome, Georgia

  • Study site

    Safford, Arizona

  • Study site

    Saginaw, Michigan

  • Study site

    Saint Cloud, Minnesota

  • Study site

    Saint Louis Park, Minnesota

  • Study site

    Saint Paul, Minnesota

  • Study site

    Salem, Oregon

  • Study site

    Salt Lake City, Utah

  • Study site

    Santa Maria, California

  • Study site

    Santa Rosa, California

  • Study site

    Santa Rosa Beach, Florida

  • Study site

    Savannah, Georgia

  • Study site

    Sayre, Pennsylvania

  • Study site

    Scottsdale, Arizona

  • Study site

    Seattle, Washington

  • Study site

    Shelby, North Carolina

  • Study site

    Shreveport, Louisiana

  • Study site

    Sioux City, Iowa

  • Study site

    Sioux Falls, South Dakota

  • Study site

    Skokie, Illinois

  • Study site

    Smithfield, North Carolina

  • Study site

    Somerville, New Jersey

  • Study site

    Sparta, New Jersey

  • Study site

    Springfield, Illinois

  • Study site

    St Louis, Missouri

  • Study site

    Stamford, Connecticut

  • Study site

    Staten Island, New York

  • Study site

    Stuttgart, Arkansas

  • Study site

    Suffolk, Virginia

  • Study site

    Tarzana, California

  • Study site

    Terre Haute, Indiana

  • Study site

    The Bronx, New York

  • Study site

    Thomasville, Georgia

  • Study site

    Toledo, Ohio

  • Study site

    Topeka, Kansas

  • Study site

    Torrance, California

  • Study site

    Tucson, Arizona

  • Study site

    Tyler, Texas

  • Study site

    Upland, Pennsylvania

  • Study site

    Urbana, Illinois

  • Study site

    Utica, New York

  • Study site

    Vallejo, California

  • Study site

    Vineland, New Jersey

  • Study site

    Washington D.C., District of Columbia

  • Study site

    Watertown, South Dakota

  • Study site

    Wellsboro, Pennsylvania

  • Study site

    West Chester, Ohio

  • Study site

    West Hills, California

  • Study site

    Weston, Wisconsin

  • Study site

    Whittier, California

  • Study site

    Wichita, Kansas

  • Study site

    Willow Grove, Pennsylvania

  • Study site

    Winston-Salem, North Carolina

  • Study site

    Winter Haven, Florida

  • Study site

    Worcester, Massachusetts

  • Study site

    York, Pennsylvania

  • Study site

    Yuma, Arizona

Other trials in United States

Puerto Rico2 sites

  • Study site

    Bayamón

  • Study site

    Ponce

Other trials in Puerto Rico

About this study

Official title: 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.

Keywords
Polycythemia, Polycythemia Vera, Hematologic Diseases, Myeloproliferative Disorders, Bone Marrow Diseases, Hydroxyurea, Antineoplastic Agents, Therapeutic Uses, Pharmacologic Actions, Antisickling Agents, Hematologic Agents, Enzyme Inhibitors, Molecular Mechanisms of Pharmacological Action, Nucleic Acid Synthesis Inhibitors
Medical subject headings
Myeloproliferative Disorders, Polycythemia, Polycythemia Vera, Hematologic Diseases, Bone Marrow Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02252159
Study groupRoleWhat they receive
Cohort APatients 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 BPatients 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Description of patterns of the disease Polycythemia Vera (PV), and associations of such patterns with patients' exposures or treatments

    Measured: Every 3 months for approximately 36 months

  2. Incidence (frequency) of disease progression

    Measured: Every 3 months for approximately 36 months

  3. Incidence (frequency) of healthcare resources utilization

    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).

    Measured: Every 3 months for approximately 36 months

  4. Incidence (frequency) of complications due to PV

    Measured: Every 3 months for approximately 36 months

  5. Incidence (frequency) and description of PV-related symptoms

    Measured: Every 3 months for approximately 36 months

Secondary outcomes (6)

  1. Incidence (frequency) of adverse events (for those patients on active therapies, including PHL)

    Measured: Baseline through end of study. Approximately 36 months

  2. Patient-reported outcomes as assessed by Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS) for assessment of the severity of symptoms

    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.

    Measured: Every 3 months for approximately 36 months

  3. Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP) score for assessment of work productivity and activity impairment

    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.

    Measured: Every 3 months for approximately 36 months

  4. European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) for Health Related Quality of Life (HRQoL)

    Measured: Every 3 months for approximately 36 months

  5. Caregiver burden

    The amount of health care received by a paid healthcare worker or by an unpaid caregiver

    Measured: Every 3 months for approximately 36 months

  6. Burden of phlebotomy (PHL)

    A patients self-reported assessment of burden including pain at site, difficulty and inconvenience of scheduling and cost factors.

    Measured: Every 3 months for approximately 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Sep 2014 (estimated)
  2. Study start31 Jul 2014
  3. Primary completion3 Aug 2019
  4. Study completion3 Aug 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,544 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02252159
Sponsor's protocol ID
INCB-MA-PV-401
Status last verified
Apr 2021
First submitted
23 Sep 2014
Last updated
26 Apr 2021
Results posted
No
Data monitoring committee
No

Publications

  • Gerds AT, Mesa R, Burke JM, Grunwald MR, Stein BL, Squier P, Yu J, Hamer-Maansson JE, Oh ST. Association between elevated white blood cell counts and thrombotic events in polycythemia vera: analysis from REVEAL. Blood. 2024 Apr 18;143(16):1646-1655. doi: 10.1182/blood.2023020232.

    PubMed 38142448

  • Zwicker JI, Paranagama D, Lessen DS, Colucci PM, Grunwald MR. Hemorrhage in patients with polycythemia vera receiving aspirin with an anticoagulant: a prospective, observational study. Haematologica. 2022 May 1;107(5):1106-1110. doi: 10.3324/haematol.2021.279032.

    PubMed 34162181

  • Grunwald MR, Burke JM, Kuter DJ, Gerds AT, Stein B, Walshauser MA, Parasuraman S, Colucci P, Paranagama D, Savona MR, Mesa R. Symptom Burden and Blood Counts in Patients With Polycythemia Vera in the United States: An Analysis From the REVEAL Study. Clin Lymphoma Myeloma Leuk. 2019 Sep;19(9):579-584.e1. doi: 10.1016/j.clml.2019.06.001. Epub 2019 Jun 13.

    PubMed 31303457

  • Mesa R, Boccia RV, Grunwald MR, Oh ST, Colucci P, Paranagama D, Parasuraman S, Stein BL. Patient-Reported Outcomes Data From REVEAL at the Time of Enrollment (Baseline): A Prospective Observational Study of Patients With Polycythemia Vera in the United States. Clin Lymphoma Myeloma Leuk. 2018 Sep;18(9):590-596. doi: 10.1016/j.clml.2018.05.020. Epub 2018 May 28.

    PubMed 30122202

Questions about this trial

What is this clinical trial studying?

An observational study of MPN (Myeloproliferative Neoplasms), run by Incyte Corporation at 266 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 266 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02252159, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2021.

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