Skip to main content
OpenTrials
Completed

NCT Number: NCT07357441

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Myelofibrosis Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Myeloproliferative Disorders Primary Myelofibrosis

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis

East Hanover, New Jersey, 07936, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

None identified.

Treatment and study plan

Primary outcomes

  1. Age

    Time frame: Baseline

  2. Number of Patients by Gender

    Time frame: Baseline

  3. Number of Patients by Clinical Characteristic Category

    Time frame: Baseline

    Clinical characteristics included:

    • Janus Kinase (JAK) mutation (yes/no)
    • MF-relevant type of mutation
    • MF Type
    • Cytogenic risk assessment (favorable/unfavorable karyotype)

  4. Time From Diagnosis to Initiation of Ruxolitinib

    Time frame: Baseline

  5. Number of Patients by DIPSS+ Risk Stratification

    Time frame: Baseline, Month 12

    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)

  6. Percentage of Patients With Blood Transfusions

    Time frame: Baseline, Month 3, 6, and 12

  7. Percentage of Patients With Splenomegaly

    Time frame: Baseline, Month 3, 6, and 12

  8. Change From Baseline in Percentage of Patients With Splenomegaly

    Time frame: Baseline, Month 12

  9. Percentage of Patients Categorized by Spleen Size

    Time frame: Baseline, Month 3, 6, and 12

    Spleen size was categorized as follows:

    • 20 centimeters (cm) or smaller
    • Bigger than 20 cm

  10. Hemoglobin Levels

    Time frame: Baseline, Month 3, 6, and 12

  11. Hematocrit Levels

    Time frame: Baseline, Month 3, 6, and 12

  12. White Blood Cell (Leukocyte) Count

    Time frame: Baseline, Month 3, 6, and 12

  13. Platelet Count

    Time frame: Baseline, Month 3, 6, and 12

  14. Lactate Dehydrogenase (LDH) Levels

    Time frame: Baseline, Month 3, 6, and 12

Secondary outcomes

  1. Number of Patients With Hematological and Non-hematological Adverse Events

    Time frame: Up to 12 months

  2. Percentage of Patients With Anemia and Thrombocytopenia

    Time frame: Baseline, Month 3, 6, and 12

  3. Percentage of Patients With Treatment Adjustments due to Anemia and Thrombocytopenia

    Time frame: Month 3, 6, and 12

    Treatment adjustments included dose modification, treatment interruption, and treatment discontinuation.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 22, 2026
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.