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

Not yet recruiting
Conditions
Polycythemia Vera
Registration Number
NCT05566535
Lead Sponsor
Multinational Center for Quality of Life Research, Russia
Brief 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

Detailed Description

Not available

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
32
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
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Exclusion Criteria
  • Patients enrolled in clinical trials
  • Patients with contraindications to Ruxo in accordance with instruction for use
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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Change From Baseline in QoL as per SF-36 questionnaire domains at 3 and 9 months of Ruxo treatmentBaseline, 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

Secondary Outcome Measures
NameTimeMethod
Percentage of patients achieving a ≥ 50% improvement from Baseline in MPN10 Total Symptom Score over time1, 3, 6, 9 and 12 months of Ruxo treatment

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

Change From Baseline in QoL as per SF-36 questionnaire domains over 12 months of Ruxo treatmentBaseline, 1, 3, 6, 9 and 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

The percentage of patients who achieved overall clinicohematologic response at 9 months of treatment with Ruxo9 months

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

The Percentage of patients who achieved hematocrit (Hct) control at 9 months of treatment with Ruxo9 months

Hematocrit control is Ht \<45% with the absence of phlebotomy eligibility beginning at 3 months visit and continuing through 9 months

The percentage of patients with positive changes of wellbeing during Ruxo treatment1, 3, 6, 9 and 12 months of 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

The percentage of patients satisfied/dissatisfied with Ruxo treatment over time1, 3, 6, 9 and 12 months of Ruxo treatment

The number of patients satisfied/dissatisfied with treatment according to Patient' Treatment Satisfaction Checklist at different time-points of treatment will be analyzed

Change From Baseline in severity of each symptom by MPN10 over timeBaseline, 1, 3, 6, 9 and 12 months of Ruxo treatment

The difference in MPN10 symptom score means at different time-points of Ruxo treatment as compared to their Baseline will be analyzed

Change From Baseline in MPN10 Total score over timeBaseline, 1, 3, 6, 9 and 12 months of Ruxo treatment

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

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