Extension Study of IDEAL (Imatinib) for Chronic Myelgenous Leukemia (CML)

Overview

This study is an extension study (prospective observational study) of 'IDEAL' study (A Study to Evaluate Efficacy and Safety of Imatinib (Glinib) 600mg/day depending on Early Molecular Response in Newly Diagnosed Patients with Chronic Myeloid Leukemia in Chronic Phase, NCT02204722) to evaluate the duration of treatment response, disease progression, and survival status up to 5 years after the inclusion.

Full Title of Study: “Extension Study of a Study to Evaluate Efficacy and Safety of Imatinib (Glinib®) 600mg/Day Depending on Early Molecular Response in Newly Diagnosed Patients With Chronic Myeloid Leukemia in Chronic Phase”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: May 2023

Detailed Description

We have started a prospective study of evaluating efficacy and safety of imatinib 600mg/day depending on early molecular response in newly diagnosed patients with chronic myelogenous leukemia in chronic phase (IDEAL, NCT02204722), which will enroll 150 patients and follow up them for 1 years for the purpose of evaluating the primary endpoints – difference of major molecular response rate at 1 year. However, Chronic myelogenous is a disease which needs long-term for the outcome of treatment with BCR-ABL tyrosine kinase inhibitor. After the end of follow-up period of IDEAL study, subjects who agree with this extension study (IDEAL-E) will be enrolled and be followed up for additional 4 years to evaluate the duration of treatment response, disease progression, and survival status. Subjects who will be enrolled in this prospective observational study will be treated with drugs – imatinib 300-600mg / nilotinib 600mg / dasatinib 100mg – which has been chosen by the each investigator according to the drug compliance and overall response. The drug choice will be at the discretion of each investigator, and the overall adverse event / molecular response will be monitored every 6 months in this prospective observational study.

Interventions

  • Drug: IDEAL-E observation (investigators choice of imatinib, nilotinib, dasatinib, radotinib)
    • After the end of follow-up period of IDEAL study, subjects who agree with this extension study (IDEAL-E) will be enrolled and be followed up for additional 4 years to evaluate the duration of treatment response, disease progression, and survival status. Subjects who will be enrolled in this prospective observational study will be treated with drugs – imatinib 300-600mg / nilotinib 600mg / dasatinib 100mg / radotinib 800mg – which has been chosen by the each investigator according to the drug compliance and overall response. The drug choice will be at the discretion of each investigator, and the overall adverse event / molecular response will be monitored every 6 months in this prospective observational study.

Arms, Groups and Cohorts

  • IDEAL-E observational group
    • Subjects who were newly diagnosed as chronic phase chronic myelogenous leukemia, were enrolled to ‘IDEAL’ study, finished the total study period of ‘IDEAL’ study or were dropped during the study period.

Clinical Trial Outcome Measures

Primary Measures

  • progression-free survival rate
    • Time Frame: 5-year

Secondary Measures

  • failure-free survival rate
    • Time Frame: 2-year
  • failure-free survival rate
    • Time Frame: 5-year
  • cumulative incidence of progression to accelerated phase / blast crisis
    • Time Frame: 2-year
  • cumulative incidence of progression to accelerated phase / blast crisis
    • Time Frame: 5-year
  • overall survival
    • Time Frame: 2-year
  • overall survival
    • Time Frame: 5-year
  • progression-free survival rate
    • Time Frame: 2-year

Participating in This Clinical Trial

Inclusion Criteria

  • Patients who were newly diagnosed as chronic phase chronic myelogenous leukemia, were enrolled to 'IDEAL study (A Phase IV Study to Evaluate Efficacy and Safety of Imatinib(Glinib®) 600mg/day Depending on Early Molecular Response in Newly Diagnosed Patients with Chronic Myeloid Leukemia in Chronic Phase, NCT02204722) – Subjects who agreed with the participation of this study after informed consent Exclusion Criteria:

  • Patients who were newly diagnosed as chronic phase chronic myelogenous leukemia, agree with the participation to 'IDEAL study (A Phase IV Study to Evaluate Efficacy and Safety of Imatinib(Glinib®) 600mg/day Depending on Early Molecular Response in Newly Diagnosed Patients with Chronic Myeloid Leukemia in Chronic Phase, NCT02204722) after informed consent, but were excluded finally from the 'IDEAL' study

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Asan Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Kyoo-Hyung Lee, Professor – Asan Medical Center
  • Overall Official(s)
    • Kyoo-Hyung Lee, MD, PhD, Principal Investigator, Asan Medical Center

References

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