A Study to Evaluate the Demographics and Treatment Patterns of Myelofibrosis Patients Treated With Ruxolitinib in Turkey

A Retrospective Chart Review Study to Evaluate the Demographics and Treatment Patterns of Myelofibrosis in Routine Practice After Ruxolitinib Approval in Turkey

This was a non-interventional retrospective study. Data from patients who were diagnosed with myelofibrosis (MF) (primary MF, post-polycythemia vera MF & post-essential thrombocythemia MF) and treated with ruxolitinib for at least 3 months collectively were collected. The baseline visit was the visit that the patient started ruxolitinib treatment. Data was collected between January 01, 2015 and December 31, 2022. The main baseline clinical and laboratory data of the cohort with at least 3 months of ruxolitinib treatment was documented in order to identify real life patient data in Turkey.

All the data was transferred to a clinical report form (CRF), then to the Statistical Package for the Social Sciences (SPSS) software in an anonymous fashion. The source documents were secured for quality control of the data. The quality control of the data was controlled by an unbiased data entry coordinator.

Study Overview

• Status: Completed
• Conditions: Myelofibrosis

• Study Type: Observational
• Enrollment (Actual): 355

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • East Hanover, New Jersey, United States, 07936
      • Novartis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This was a retrospective, non-interventional cohort study.

Description

Inclusion Criteria:

• Diagnosed with MF
• Treated with ruxolitinib for at least 3 months

Exclusion Criteria:

None identified.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Ruxolitinib Group 1; Patients diagnosed with intermediate-1 risk MF according to the Dynamic International Prognostic Scoring System Plus (DIPSS+) at the initial visit who were treated with ruxolitinib.
Ruxolitinib Group 2; Patients diagnosed with intermediate-2 and High risk MF according to the DIPSS+ at the initial visit who were treated with ruxolitinib.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age		Baseline
Number of Patients by Gender		Baseline
Number of Patients by Clinical Characteristic Category	Clinical characteristics included: Janus Kinase (JAK) mutation (yes/no); MF-relevant type of mutation; MF Type; Cytogenic risk assessment (favorable/unfavorable karyotype)	Baseline
Time From Diagnosis to Initiation of Ruxolitinib		Baseline
Number of Patients by DIPSS+ Risk Stratification	DIPSS+ is a prognostic scoring system used to assign MF patients into 1 of 4 risk categories based on the 8 risk factors: age, hemoglobin level, leukocyte count, percentage of circulating blast cells, presence of constitutional symptoms, platelet count, need for red blood cell transfusion, and unfavorable karyotype. The 4 risk categories are as follows: Low risk (0 points); Intermediate-1 risk (1 point); Intermediate-2 risk (2-3 points); High risk (4-6 points)	Baseline, Month 12
Percentage of Patients With Blood Transfusions		Baseline, Month 3, 6, and 12
Percentage of Patients With Splenomegaly		Baseline, Month 3, 6, and 12
Change From Baseline in Percentage of Patients With Splenomegaly		Baseline, Month 12
Percentage of Patients Categorized by Spleen Size	Spleen size was categorized as follows: 20 centimeters (cm) or smaller; Bigger than 20 cm	Baseline, Month 3, 6, and 12
Hemoglobin Levels		Baseline, Month 3, 6, and 12
Hematocrit Levels		Baseline, Month 3, 6, and 12
White Blood Cell (Leukocyte) Count		Baseline, Month 3, 6, and 12
Platelet Count		Baseline, Month 3, 6, and 12
Lactate Dehydrogenase (LDH) Levels		Baseline, Month 3, 6, and 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients With Hematological and Non-hematological Adverse Events		Up to 12 months
Percentage of Patients With Anemia and Thrombocytopenia		Baseline, Month 3, 6, and 12
Percentage of Patients With Treatment Adjustments due to Anemia and Thrombocytopenia	Treatment adjustments included dose modification, treatment interruption, and treatment discontinuation.	Month 3, 6, and 12

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2022
• Primary Completion (Actual): June 28, 2023
• Study Completion (Actual): June 28, 2023

Study Registration Dates

• First Submitted: January 13, 2026
• First Submitted That Met QC Criteria: January 13, 2026
• First Posted (Actual): January 22, 2026

Study Record Updates

• Last Update Posted (Actual): January 22, 2026
• Last Update Submitted That Met QC Criteria: January 13, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Real life; Retrospective; Chart review
• Additional Relevant MeSH Terms: Hematologic Diseases; Bone Marrow Diseases; Myeloproliferative Disorders; Hemic and Lymphatic Diseases; Primary Myelofibrosis
• Other Study ID Numbers: CINC424ATR01