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

NCT07150793 | Completed

• 1 other identifier: CAMN107AJP11
• Study Type: observational
• Target: 754
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Myeloid Leukemia, Chronic

Keywords

Tyrosine Kinase Inhibitor; Real-world

Outcome Measures

Primary Outcomes (8)

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

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

  Up to approximately 9 years

• Number of Patients who Switched TKI Treatment by LoT and TKI

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

  Up to approximately 9 years

• Number of Patients who Discontinued TKI Treatment by Type of TKI

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

  Up to approximately 9 years

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

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

  Up to approximately 9 years

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

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

  Up to approximately 9 years

• TKI Dose by LoT

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

  Baseline, up to approximately 9 years

• TKI Persistence Rate by LoT

  Months 6, 12, 18, and Year 5

• Duration of TKI Treatment by LoT

  Up to approximately 9 years

Secondary Outcomes (5)

• Annual Incidence of Inpatient and Outpatient Visits by LoT

  Up to approximately 9 years

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

  Up to approximately 9 years

• Annual Incidence of CML-related Healthcare Resource Use by LoT

  Up to approximately 9 years

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

  Up to approximately 9 years

• Number of Patients With Adverse Events by TKI

  Up to approximately 9 years

Study Arms (1)

CML Cohort

Patients diagnosed with chronic phase CML who received treatment with a TKI in Japan between 01 January 2011 and 31 December 2019.

Eligibility Criteria

• Age: 15 Years+
• 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 not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis

East Hanover, New Jersey, 07936, United States

Location

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Condition Hierarchy (Ancestors)

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

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: August 27, 2025
• First Posted: September 2, 2025
• Study Start: July 5, 2022
• Primary Completion: February 8, 2023
• Study Completion: February 8, 2023
• Last Updated: September 2, 2025

Record last verified: 2025-08

Locations

US (1)