QoL-PV-R: Changes in QoL and Symptoms in Patients With Polycythemia Vera Receiving Ruxo in a Routine Clinical Practice

• Sponsor: Multinational Center for Quality of Life Research, Russia (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05566535
• Collaborator: (none)
• Enrollment: 32
• Anticipated Duration (Months): 22

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Polycythemia Vera	Drug: Ruxolitinib

Study Design

• Study Type: Observational
• Anticipated Enrollment: 32 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Changes in Quality of Life (QoL) and Symptoms in Patients With Polycythemia Vera (PV) Receiving Ruxolitinib (Ruxo) in a Routine Clinical Practice
• Anticipated Study Start Date: Oct 1, 2022
• Anticipated Primary Completion Date: May 1, 2024
• Anticipated Study Completion Date: Aug 1, 2024

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in QoL as per SF-36 questionnaire domains at 3 and 9 months of Ruxo treatment [Baseline, 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

1. Change From Baseline in MPN10 Total score over time [Baseline, 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

2. Change From Baseline in severity of each symptom by MPN10 over time [Baseline, 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

3. Percentage of patients achieving a ≥ 50% improvement from Baseline in MPN10 Total Symptom Score over time [1, 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

4. Change From Baseline in QoL as per SF-36 questionnaire domains over 12 months of Ruxo treatment [Baseline, 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

5. The percentage of patients who achieved overall clinicohematologic response at 9 months of treatment with Ruxo [9 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

6. The Percentage of patients who achieved hematocrit (Hct) control at 9 months of treatment with Ruxo [9 months]

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

7. The percentage of patients with positive changes of wellbeing during Ruxo treatment [1, 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

8. The percentage of patients satisfied/dissatisfied with Ruxo treatment over time [1, 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Multinational Center for Quality of Life Research, Russia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Multinational Center for Quality of Life Research, Russia
• ClinicalTrials.gov Identifier: NCT05566535
• Other Study ID Numbers: CINC424BRU04T
• First Posted: Oct 4, 2022
• Last Update Posted: Oct 4, 2022
• Last Verified: Sep 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Multinational Center for Quality of Life Research, Russia: ruxolitinib; quality of life
• Additional relevant MeSH terms: Polycythemia Vera; Polycythemia

Study Results

No Results Posted as of Oct 4, 2022