Overview

This trial is active, not recruiting.

Condition polycythemia vera
Sponsor Incyte Corporation
Start date July 2014
End date August 2018
Trial size 2544 participants
Trial identifier NCT02252159, INCB-MA-PV-401

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 enrolled over a 12-month period and observed for 36 months from the date the last patient is enrolled.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Patients with clinically overt PV (and not exhibiting any of the characteristics listed for Cohort B), managed with: Watchful waiting (with or without aspirin)*, or Phlebotomy (PHL) alone (with or without aspirin)* - or 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)
Patients with clinically overt PV, with one or more of the following disease characteristics: Treatment with HU and PHL in combination or Treatment with any agent other than HU or aspirin (e.g., recombinant interferon (IFN) or pegylated IFN preparations, busulfan, anagrelide) or A history of thrombosis (venous or arterial) or A history of intolerance or clinical resistance/ refractoriness to HU (as assessed by the treating physician) or Presence of documented splenomegaly (clinically assessed by palpation) or Presence of one or more of the following uncontrolled symptoms related to PV despite therapy (Symptoms deemed uncontrolled as per physician's judgment) Tiredness Difficulty sleeping Itching Muscle aches and/or bone pain Night sweats Sweats while awake Other

Primary Outcomes

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
Incidence (frequency) of disease progression
time frame: Every 3 months for approximately 36 months
Incidence (frequency) of healthcare resources utilization
time frame: Every 3 months for approximately 36 months
Incidence (frequency) of complications due to PV
time frame: Every 3 months for approximately 36 months
Incidence (frequency) and description of PV-related symptoms
time frame: Every 3 months for approximately 36 months

Secondary Outcomes

Measure
Incidence (frequency) of adverse events (for those patients on active therapies, including PHL)
time frame: 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
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
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
Caregiver burden
time frame: Every 3 months for approximately 36 months
Burden of phlebotomy (PHL)
time frame: Every 3 months for approximately 36 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Prospective, Non-interventional Study of Disease Progression and Treatment of Patients With Polycythemia Vera in United States Academic or Community Clinical Practices
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Incyte Corporation.
Location data was received from the National Cancer Institute and was last updated in August 2016.