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

NCT07357441 | Completed

• 1 other identifier: CINC424ATR01
• Study Type: observational
• Target: 355
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Myelofibrosis

Keywords

Real life; Retrospective; Chart review

Outcome Measures

Primary Outcomes (14)

• 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 Outcomes (3)

• 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

  Month 3, 6, and 12

Study Arms (2)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This was a retrospective, non-interventional cohort study.

You may qualify if:

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

You may not qualify if:

• None identified.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis

East Hanover, New Jersey, 07936, United States

Location

MeSH Terms

Conditions

Primary Myelofibrosis

Condition Hierarchy (Ancestors)

Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2026
• First Posted: January 22, 2026
• Study Start: April 7, 2022
• Primary Completion: June 28, 2023
• Study Completion: June 28, 2023
• Last Updated: January 22, 2026

Record last verified: 2026-01

Locations

US (1)