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

Withdrawn

Interventions: Drug: IDEAL-E observation (investigators choice of imatinib, nilotinib, dasatinib, radotinib)

Brief Summary: 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.

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
IDEAL-E observational group	IDEAL-E observation (investigators choice of imatinib, nilotinib, dasatinib, radotinib)	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.

Primary Outcome Measures

Name	Time	Method
progression-free survival rate	5-year

Secondary Outcome Measures

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

Locations (12): Gachon University Gil Hospital
🇰🇷
Incheon, Korea, Republic of
Korea University Anam Hospital
🇰🇷
Seoul, Korea, Republic of
Chungnam National University Hospital
🇰🇷
Daejeon, Korea, Republic of
Seoul National University Hospital
🇰🇷
Seoul, Korea, Republic of
Ajou University Hospital
🇰🇷
Suwon, Korea, Republic of
Korea University Ansan Hospital
🇰🇷
Ansan, Korea, Republic of
Busan National University Hospital
🇰🇷
Busan, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷
Seongnam, Gyong-gi Province, Korea, Republic of
Haeundae Paik Hospital
🇰🇷
Busan, Korea, Republic of
Soonchyunhyang University Hospital
🇰🇷
Seoul, Korea, Republic of
Korea University Guro Hospital
🇰🇷
Seoul, Korea, Republic of
Asan Medical Center
🇰🇷
Seoul, Korea, Republic of