Brief 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.
Brief Title
Prospective Observational Study Of Patients With Polycythemia Vera In US Clinical Practices (REVEAL)
Categories
Completion Date
Completion Date Type
Actual
Conditions
MPN (Myeloproliferative Neoplasms)
Eligibility Criteria
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
* 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
Inclusion Criteria
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
* 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
Gender
All
Gender Based
false
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
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT02252159
Org Class
Industry
Org Full Name
Incyte Corporation
Org Study Id
INCB-MA-PV-401
Overall Status
Completed
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Prospective, Non-interventional Study of Disease Progression and Treatment of Patients With Polycythemia Vera in United States Academic or Community Clinical Practices
Primary Outcomes
Outcome Measure
Description of patterns of the disease Polycythemia Vera (PV), and associations of such patterns with patients' exposures or treatments
Outcome Time Frame
Every 3 months for approximately 36 months
Outcome Measure
Incidence (frequency) of disease progression
Outcome Time Frame
Every 3 months for approximately 36 months
Outcome Description
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).
Outcome Measure
Incidence (frequency) of healthcare resources utilization
Outcome Time Frame
Every 3 months for approximately 36 months
Outcome Measure
Incidence (frequency) of complications due to PV
Outcome Time Frame
Every 3 months for approximately 36 months
Outcome Measure
Incidence (frequency) and description of PV-related symptoms
Outcome Time Frame
Every 3 months for approximately 36 months
Secondary Outcomes
Outcome Time Frame
Baseline through end of study. Approximately 36 months
Outcome Measure
Incidence (frequency) of adverse events (for those patients on active therapies, including PHL)
Outcome Description
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.
Outcome Time Frame
Every 3 months for approximately 36 months
Outcome Measure
Patient-reported outcomes as assessed by Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS) for assessment of the severity of symptoms
Outcome Description
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.
Outcome Time Frame
Every 3 months for approximately 36 months
Outcome Measure
Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP) score for assessment of work productivity and activity impairment
Outcome Time Frame
Every 3 months for approximately 36 months
Outcome Measure
European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) for Health Related Quality of Life (HRQoL)
Outcome Description
The amount of health care received by a paid healthcare worker or by an unpaid caregiver
Outcome Time Frame
Every 3 months for approximately 36 months
Outcome Measure
Caregiver burden
Outcome Description
A patients self-reported assessment of burden including pain at site, difficulty and inconvenience of scheduling and cost factors.
Outcome Time Frame
Every 3 months for approximately 36 months
Outcome Measure
Burden of phlebotomy (PHL)
See Also Links
Url
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
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.
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Ellen Friedman
Investigator Email
elfriedm@montefiore.org
Investigator Phone
Categories Mesh Debug
Blood & Bone Marrow Cancers --- MYELOPROLIFERATIVE DISORDERS
Blood Disorders --- HEMATOLOGIC DISEASES
Blood & Bone Marrow Cancers --- HEMATOLOGIC DISEASES
Blood & Bone Marrow Cancers --- BONE MARROW DISEASES
Blood & Bone Marrow Cancers --- HEMATOLOGIC NEOPLASMS
Cancer --- NEOPLASMS BY SITE
Cancer --- NEOPLASMS
MeSH Terms
MYELOPROLIFERATIVE DISORDERS
POLYCYTHEMIA
POLYCYTHEMIA VERA
HEMATOLOGIC DISEASES
BONE MARROW DISEASES
HEMIC AND LYMPHATIC DISEASES
BONE MARROW NEOPLASMS
HEMATOLOGIC NEOPLASMS
NEOPLASMS BY SITE
NEOPLASMS