Trial Title:
Study to Identify and Describe Predictive Factors for Thromboembolic Events in Patients With High-risk Polycythemia Vera
NCT ID:
NCT05548062
Condition:
Polycythemia Vera
Conditions: Official terms:
Polycythemia Vera
Thromboembolism
Polycythemia
Hydroxyurea
Conditions: Keywords:
polycythemia vera
high-risk polycythemia vera
PV
Ruxolitinib
NIS
Italy
TE
predictive factors
hydroxyurea
Study type:
Observational
Overall status:
Active, not recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Hydroxyurea
Description:
Prospective observational study. There is no treatment allocation. Patients prescribed
with Hydroxyurea are eligible to enroll into this study.
Arm group label:
Hydroxyurea
Intervention type:
Other
Intervention name:
Ruxolitinib
Description:
Prospective observational study. There is no treatment allocation. Patients prescribed
with Ruxolitinib are eligible to enroll into this study.
Arm group label:
Ruxolitinib
Summary:
This is a prospective observational study that will enroll patients with high-risk
Polycythemia Vera (PV) with at least one Thromboembolic Event (TE) after diagnosis or up
to 2 years prior to diagnosis.
This is a non-randomized study, and to ensure a sufficient number of patients in both
cohorts, enrollment in each cohort will be terminated once the target of 150 patients has
been reached.
Detailed description:
All patients are already on treatment with hydroxyurea or ruxolitinib at enrollment as
per clinical practice and independently of their participation in this study. In
addition, the follow-up visits and the evaluation procedures required in the study
protocol correspond to current clinical practice. According to local regulations related
to observational studies, assessments such as blood tests are justified by the purpose
and rationale of the study (i.e., the identification of possible predictive factors of
TEs) and are considered current clinical practice. Data related to other procedures will
be collected only if such procedures are performed as per clinical practice but are not
required otherwise.
Patients in both cohorts will be followed for 3 years after enrollment and will have
visits at Months 6, 12, 18, 24, 30 and 36. A time window of ± 1 month is permitted for
all visits.
Criteria for eligibility:
Study pop:
The study will involve patients in Italy with high-risk Polycythemia Vera
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
1. Signed informed consent must be obtained prior to participation in the study.
2. Age ≥18 years.
3. Diagnosis of PV according to WHO 2008 or WHO 2016 and high-risk stratification
according to European LeukemiaNet (ELN) classification.
4. At least one TE after diagnosis or up to 2 years prior to diagnosis.
5. Patients on treatment with hydroxyurea at enrollment and for at least 18 months
prior to enrollment or those on treatment with ruxolitinib who started treatment up
to 18 months before enrollment.
Gender:
All
Minimum age:
18 Years
Maximum age:
99 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Novartis Investigative Site
Address:
City:
Alessandria
Zip:
15100
Country:
Italy
Facility:
Name:
Novartis Investigative Site
Address:
City:
Ancona
Zip:
60126
Country:
Italy
Facility:
Name:
Novartis Investigative Site
Address:
City:
Bari
Zip:
70124
Country:
Italy
Facility:
Name:
Novartis Investigative Site
Address:
City:
Bologna
Zip:
40138
Country:
Italy
Facility:
Name:
Novartis Investigative Site
Address:
City:
Como
Zip:
22100
Country:
Italy
Facility:
Name:
Novartis Investigative Site
Address:
City:
Cosenza
Zip:
87100
Country:
Italy
Facility:
Name:
Novartis Investigative Site
Address:
City:
Catania
Zip:
95123
Country:
Italy
Facility:
Name:
Novartis Investigative Site
Address:
City:
Firenze
Zip:
50134
Country:
Italy
Facility:
Name:
Novartis Investigative Site
Address:
City:
Genova
Zip:
16132
Country:
Italy
Facility:
Name:
Novartis Investigative Site
Address:
City:
Lecce
Zip:
73100
Country:
Italy
Facility:
Name:
Novartis Investigative Site
Address:
City:
Tricase
Zip:
73039
Country:
Italy
Facility:
Name:
Novartis Investigative Site
Address:
City:
Monza
Zip:
20900
Country:
Italy
Facility:
Name:
Novartis Investigative Site
Address:
City:
Milano
Zip:
20122
Country:
Italy
Facility:
Name:
Novartis Investigative Site
Address:
City:
Palermo
Zip:
90127
Country:
Italy
Facility:
Name:
Novartis Investigative Site
Address:
City:
Palermo
Zip:
90146
Country:
Italy
Facility:
Name:
Novartis Investigative Site
Address:
City:
Piacenza
Zip:
29100
Country:
Italy
Facility:
Name:
Novartis Investigative Site
Address:
City:
Padova
Zip:
35100
Country:
Italy
Facility:
Name:
Novartis Investigative Site
Address:
City:
Padova
Zip:
35128
Country:
Italy
Facility:
Name:
Novartis Investigative Site
Address:
City:
Pisa
Zip:
56126
Country:
Italy
Facility:
Name:
Novartis Investigative Site
Address:
City:
Parma
Zip:
43100
Country:
Italy
Facility:
Name:
Novartis Investigative Site
Address:
City:
Reggio Calabria
Zip:
89124
Country:
Italy
Facility:
Name:
Novartis Investigative Site
Address:
City:
Reggio Emilia
Zip:
42100
Country:
Italy
Facility:
Name:
Novartis Investigative Site
Address:
City:
Roma
Zip:
00161
Country:
Italy
Facility:
Name:
Novartis Investigative Site
Address:
City:
Roma
Zip:
00168
Country:
Italy
Facility:
Name:
Novartis Investigative Site
Address:
City:
Roma
Zip:
00189
Country:
Italy
Facility:
Name:
Novartis Investigative Site
Address:
City:
Pagani
Zip:
84016
Country:
Italy
Facility:
Name:
Novartis Investigative Site
Address:
City:
Orbassano
Zip:
10043
Country:
Italy
Facility:
Name:
Novartis Investigative Site
Address:
City:
Torino
Zip:
10126
Country:
Italy
Facility:
Name:
Novartis Investigative Site
Address:
City:
Terni
Zip:
05100
Country:
Italy
Facility:
Name:
Novartis Investigative Site
Address:
City:
Varese
Zip:
21100
Country:
Italy
Facility:
Name:
Novartis Investigative Site
Address:
City:
Vicenza
Zip:
36100
Country:
Italy
Facility:
Name:
Novartis Investigative Site
Address:
City:
Verona
Zip:
37126
Country:
Italy
Facility:
Name:
Novartis Investigative Site
Address:
City:
Viterbo
Zip:
01033
Country:
Italy
Facility:
Name:
Novartis Investigative Site
Address:
City:
Napoli
Zip:
80131
Country:
Italy
Facility:
Name:
Novartis Investigative Site
Address:
City:
Napoli
Zip:
80132
Country:
Italy
Start date:
March 2, 2023
Completion date:
August 31, 2027
Lead sponsor:
Agency:
Novartis Pharmaceuticals
Agency class:
Industry
Source:
Novartis
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05548062
