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

Incyte

Status: Completed

Conditions: MPN (Myeloproliferative Neoplasms)

Study type: Observational

Funder types: Industry

Identifiers

NCT02252159

INCB-MA-PV-401

Details and patient eligibility

About

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.

Enrollment: 2,544 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

2,544 participants in 2 patient groups

Cohort A

Description:

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

Description:

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