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

July 5, 2019 updated by: Kyoo-Hyung Lee, Asan Medical Center

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Ansan, Korea, Republic of
        • Korea University Ansan Hospital
      • Busan, Korea, Republic of
        • Busan National University Hospital
      • Busan, Korea, Republic of
        • Haeundae Paik Hospital
      • Daejeon, Korea, Republic of
        • Chungnam National University Hospital
      • Incheon, Korea, Republic of
        • Gachon University Gil Hospital
      • Seoul, Korea, Republic of
        • Seoul National University Hospital
      • Seoul, Korea, Republic of
        • Asan Medical Center
      • Seoul, Korea, Republic of
        • Korea University Guro Hospital
      • Seoul, Korea, Republic of
        • Korea University Anam Hospital
      • Seoul, Korea, Republic of
        • Soonchyunhyang University Hospital
      • Suwon, Korea, Republic of
        • Ajou University Hospital
    • Gyong-gi Province
      • Seongnam, Gyong-gi Province, Korea, Republic of
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who were newly dianosed as chronic phase chronic myelogenous leukemia, were enrolled to 'IDEAL' study, and were followed up

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.
Other Names:
  • glinib, sprycel, tasigna, supect

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
progression-free survival rate
Time Frame: 5-year
5-year

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Time Frame
cumulative incidence of hematologic adverse events
Time Frame: 2-year
2-year
cumulative incidence of hematologic adverse events
Time Frame: 5-year
5-year
cumulative incidence of non-hematologic adverse events
Time Frame: 2-year
2-year
cumulative incidence of non-hematologic adverse events
Time Frame: 5-year
5-year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Investigators

  • Principal Investigator: Kyoo-Hyung Lee, MD, PhD, Asan Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Anticipated)

May 1, 2023

Study Completion (Anticipated)

May 1, 2023

Study Registration Dates

First Submitted

April 16, 2015

First Submitted That Met QC Criteria

April 20, 2015

First Posted (Estimate)

April 21, 2015

Study Record Updates

Last Update Posted (Actual)

July 8, 2019

Last Update Submitted That Met QC Criteria

July 5, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-99

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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