Changes in QoL and Symptoms in Patients With Polycythemia Vera Receiving Ruxo in a Routine Clinical Practice

Polycythemia Vera Clinical Trial

— QoL-PV-R  

Official title:

Changes in Quality of Life (QoL) and Symptoms in Patients With Polycythemia Vera (PV) Receiving Ruxolitinib (Ruxo) in a Routine Clinical Practice

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05566535
• Other study ID #: CINC424BRU04T
• Status: Not yet recruiting
• Start date: October 1, 2022
• Est. completion date: August 1, 2024

Study information

• Verified date: September 2022
• Source: Multinational Center for Quality of Life Research, Russia
• Contact: Tatiana Nikitina, MD, PhD
• Phone: 89627101712
• Email: tnikitina_74[@]mail.ru
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this multicenter observational prospective cohort study is to examine changes in QoL and symptoms in patients with polycythemia vera (PV) during treatment with ruxolitinib (Ruxo), and to evaluate efficacy and safety of Ruxo in a real-world setting

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 32
• Est. completion date: August 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients who have confirmed diagnosis of PV
• Patients whose age - 18 years and older
• Patients who signed informed consent
• Patients who able to fill out questionnaires

Exclusion Criteria:

• Patients enrolled in clinical trials
• Patients with contraindications to Ruxo in accordance with instruction for use

Related Conditions & MeSH terms

• Polycythemia
• Polycythemia Vera

Intervention

Drug:
• Ruxolitinib
Ruxo will be administered to patients with PV in a real-world setting. Treatment with Ruxo is according to local approved label. Ruxo treatment should be administered according to drug official instruction and in compliance with clinical practice at the certain medical center.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Multinational Center for Quality of Life Research, Russia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in QoL as per SF-36 questionnaire domains at 3 and 9 months of Ruxo treatment	The difference in QoL means of SF-36 domains at 3 and 9 months as compared to their Baseline will be analyzed	Baseline, 3 and 9 months of Ruxo treatment
Secondary	Change From Baseline in MPN10 Total score over time	The difference in MPN10 Total Symptom Score means by MPN10 at different time-points of Ruxo treatment as compared to their Baseline will be analyzed. Also the percentage of patients with the lowest symptom burden, corresponding to MPN10 Total scores of 0 - 7 (quartile 1), at different treatment time-points (Baseline, 1, 3, 6, 9 and 12 months) will be calculated	Baseline, 1, 3, 6, 9 and 12 months of Ruxo treatment
Secondary	Change From Baseline in severity of each symptom by MPN10 over time	The difference in MPN10 symptom score means at different time-points of Ruxo treatment as compared to their Baseline will be analyzed	Baseline, 1, 3, 6, 9 and 12 months of Ruxo treatment
Secondary	Percentage of patients achieving a = 50% improvement from Baseline in MPN10 Total Symptom Score over time	The number of patients with MPN10 Total Symptom Score decrease = 50% at 1, 3, 6, 9 and 12 months of Ruxo treatment as compared to its' Baseline will be calculated	1, 3, 6, 9 and 12 months of Ruxo treatment
Secondary	Change From Baseline in QoL as per SF-36 questionnaire domains over 12 months of Ruxo treatment	The difference in QoL means of SF-36 domains at different time-points of Ruxo treatment as compared to their Baseline will be analyzed	Baseline, 1, 3, 6, 9 and 12 months of Ruxo treatment
Secondary	The percentage of patients who achieved overall clinicohematologic response at 9 months of treatment with Ruxo	Overall clinicohematologic response will be defined as any participant who achieved a complete or partial clinicohematologic response per the National criteria for response in polycythemia vera (2021) and European LeukNet recommendations (2013). A complete response (CR) will be defined as: hematocrit control (<45%) with the absence of phlebotomy eligibility =12 weeks, spleen volume reduction at least 35% from baseline, platelet count less than or equal to 400 x 109/L, and white blood cell count less than or equal to 10 x 109/L, and symptom regress during =12 weeks as well as histological remission. A Partial Response (PR) will be defined as all the above criteria excluding histological remission	9 months
Secondary	The Percentage of patients who achieved hematocrit (Hct) control at 9 months of treatment with Ruxo	Hematocrit control is Ht <45% with the absence of phlebotomy eligibility beginning at 3 months visit and continuing through 9 months	9 months
Secondary	The percentage of patients with positive changes of wellbeing during Ruxo treatment	The number of patients who reported improvement as per Patient Global Impression of Changes scale at different time-points of treatment will be analyzed	1, 3, 6, 9 and 12 months of Ruxo treatment
Secondary	The percentage of patients satisfied/dissatisfied with Ruxo treatment over time	The number of patients satisfied/dissatisfied with treatment according to Patient' Treatment Satisfaction Checklist at different time-points of treatment will be analyzed	1, 3, 6, 9 and 12 months of Ruxo treatment