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Completed

NCT Number: NCT07150793

A Study of Real-world Treatment and Burden of Chronic Myeloid Leukemia Patients in Japan

The main goal of this study was to describe treatment patterns of patients with chronic myeloid leukemia (CML) who were treated with tyrosine kinase inhibitors (TKIs) in Japan.

This was a retrospective observational study with secondary use of data from the Medical Data Vision (MDV) hospital-based database. The index date was the date of the first prescription of any TKI of interest registered within the selection period (01 January 2011 to 31 December 2019). The follow-up period was from the index date until the end of the study period, end of continuous follow-up in the MDV database, or death, whichever came first.

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Key information

Conditions

Myeloid Leukemia, Chronic Bone Marrow Diseases Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

15 year and older

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.

Patients who met all the below inclusion criteria and none of the exclusion criteria were included in the study.

Inclusion criteria

  • Patients who had at least one TKI prescription during the selection period,
  • a confirmed diagnosis of chronic phase CML recorded before or at the index date,
  • were aged 15 years or older at the index date, and
  • had at least 12-months continuous pre-index period.

Exclusion criteria

  • Patients who had at least one TKI prescription in the 12 months preceding the index date (washout period to catch the 1st line of treatment [LoT]),
  • a confirmed diagnosis of CML blast crisis or accelerated phase recorded prior to, at, or within 6 months after the index date,
  • a confirmed diagnosis of acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) within 6 months after the index date,
  • a medical record of chemotherapy (not including hydroxyurea) within 6 months after the index date,
  • a stem cell transplant procedure recorded during the pre-index period.

Treatment and study plan

Primary outcomes

  1. Number of Patients by Line of Treatment (LoT) and TKI Received

    Time frame: Up to approximately 9 years

    TKIs included imatinib, bosutinib, dasatinib, nilotinib, and ponatinib.

  2. Number of Patients who Switched TKI Treatment by LoT and TKI

    Time frame: Up to approximately 9 years

    TKIs included imatinib, bosutinib, dasatinib, nilotinib, and ponatinib.

  3. Number of Patients who Discontinued TKI Treatment by Type of TKI

    Time frame: Up to approximately 9 years

    TKIs included imatinib, bosutinib, dasatinib, nilotinib, and ponatinib.

  4. Number of Patients who Discontinued TKI Treatment for at Least One Year by Type of TKI

    Time frame: Up to approximately 9 years

    TKIs included imatinib, bosutinib, dasatinib, nilotinib, and ponatinib.

  5. Number of Patients who Restarted any TKI Treatment After Discontinuing the TKI of Interest by Type of TKI

    Time frame: Up to approximately 9 years

    TKIs included imatinib, bosutinib, dasatinib, nilotinib, and ponatinib.

  6. TKI Dose by LoT

    Time frame: Baseline, up to approximately 9 years

    TKIs included imatinib, bosutinib, dasatinib, nilotinib, and ponatinib.

  7. TKI Persistence Rate by LoT

    Time frame: Months 6, 12, 18, and Year 5

  8. Duration of TKI Treatment by LoT

    Time frame: Up to approximately 9 years

Secondary outcomes

  1. Annual Incidence of Inpatient and Outpatient Visits by LoT

    Time frame: Up to approximately 9 years

  2. Annual Mean Cost of All-cause Healthcare Resource Use by LoT

    Time frame: Up to approximately 9 years

    All-cause care included inpatient and outpatient visits. The following costs were calculated in Japanese yen (JPN):

    • Total costs
    • Inpatient costs
    • Outpatient costs
    • Pharmacy costs

  3. Annual Incidence of CML-related Healthcare Resource Use by LoT

    Time frame: Up to approximately 9 years

    CML-related care included:

    • Major BCR-ABL1 procedures (diagnostic and response to treatment testing)
    • Complete blood count testing - peripheral blood general testing
    • Hematological examination diagnosis fee
    • TKI prescriptions

  4. Annual Mean Cost of CML-related Healthcare Resource Use by LoT

    Time frame: Up to approximately 9 years

    CML-related care costs were calculated in Japanese Yen (JPY) and included the following:

    • Total CML-related costs
    • Major BCR-ABL1 procedure costs
    • Complete blood count testing - peripheral blood general testing costs
    • Hematological examination costs
    • TKI prescription costs

  5. Number of Patients With Adverse Events by TKI

    Time frame: Up to approximately 9 years

    TKIs included imatinib, bosutinib, dasatinib, nilotinib, and ponatinib.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

Real-world Treatment and Burden of Chronic Myeloid Leukemia Patients in Japan - A Retrospective Claims Database Analysis

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 2, 2025
Registry last updated
Sep 2, 2025

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.

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