Clinical trial · Observational
Prospective Observational Study Of Patients With Polycythemia Vera In US Clinical Practices (REVEAL)
Prospective, Non-interventional Study of Disease Progression and Treatment of Patients With Polycythemia Vera in United States Academic or Community Clinical Practices
NCT02252159CI-TRIAL-00051438completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| MPN (Myeloproliferative Neoplasms) | Myeloproliferative Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- 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)
- label
- 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
Primary outcomes (5)
- measure
- Description of patterns of the disease Polycythemia Vera (PV), and associations of such patterns with patients' exposures or treatments
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (4)
- DERIVEDGerds 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. PMID 38142448
- DERIVEDZwicker 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. PMID 34162181
- DERIVEDGrunwald 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. PMID 31303457
- DERIVEDMesa 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. PMID 30122202