Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05566535
Other study ID # CINC424BRU04T
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05558696 - A Study of Bomedemstat (MK-3543) in Participants With Polycythemia Vera (MK-3543-004) Phase 2
Active, not recruiting NCT03289910 - Topotecan Hydrochloride and Carboplatin With or Without Veliparib in Treating Advanced Myeloproliferative Disorders and Acute Myeloid Leukemia or Chronic Myelomonocytic Leukemia Phase 2
Completed NCT02912884 - Treatment of Polycythaemia Vera and Essential Thrombocythaemia: Influence on the Clot Structure
Recruiting NCT02897297 - Myeloproliferative Neoplastic Diseases Observatory From Brest
Completed NCT01949805 - Pegylated Interferon Alpha-2b Versus Hydroxyurea in Polycythemia Vera Phase 3
Completed NCT00666549 - Research Tissue Bank
Completed NCT00241241 - Efficacy and Safety of Pegylated Interferon Alfa in Polycythemia Vera Phase 2
Completed NCT00052520 - Biological Therapy in Treating Patients With Advanced Myelodysplastic Syndrome, Acute or Chronic Myeloid Leukemia, or Acute Lymphoblastic Leukemia Who Are Undergoing Stem Cell Transplantation Phase 1/Phase 2
Active, not recruiting NCT05485948 - A Study to Access Efficacy and Safety of P1101 in Chinese PV Patients Who Are Intolerant or Resistance to HU Phase 2
Completed NCT01588015 - Vaccine Therapy in Preventing Cytomegalovirus Infection in Patients With Hematological Malignancies Undergoing Donor Stem Cell Transplant Phase 1
Completed NCT01243944 - Study of Efficacy and Safety in Polycythemia Vera Subjects Who Are Resistant to or Intolerant of Hydroxyurea: JAK Inhibitor INC424 (INCB018424) Tablets Versus Best Available Care: (The RESPONSE Trial) Phase 3
Recruiting NCT05481151 - A Study to Assess Efficacy, Safety, and Tolerability of P1101 in Adult Patients With PV Phase 3
Recruiting NCT05031897 - Reduced-Intensity Conditioning for the Prevention of Treatment-Related Mortality in Patients Who Undergo a Hematopoietic Stem Cell Transplant Phase 2
Recruiting NCT04116502 - MITHRIDATE: Ruxolitinib Versus Hydroxycarbamide or Interferon as First Line Therapy in High Risk Polycythemia Vera Phase 3
Completed NCT01901432 - A Two-part Study to Assess the Safety and Preliminary Efficacy of Givinostat in Patients With Polycythemia Vera Phase 1/Phase 2
Active, not recruiting NCT04262141 - IMG-7289 in Patients With Essential Thrombocythemia (ET) or Polycythemia Vera (PV) Phase 2
Active, not recruiting NCT04057040 - Hepcidin Mimetic in Patients With Polycythemia Vera (REVIVE) Phase 2
Completed NCT03907436 - The NUTRIENT Trial (NUTRitional Intervention Among myEloproliferative Neoplasms): Feasibility Phase N/A
Completed NCT01981850 - A Phase 2 Study of RO7490677 In Participants With Myelofibrosis Phase 2
Active, not recruiting NCT00588991 - Veliparib and Topotecan With or Without Carboplatin in Treating Patients With Relapsed or Refractory Acute Leukemia, High-Risk Myelodysplasia, or Aggressive Myeloproliferative Disorders Phase 1