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

Asan Medical Center

Status: Withdrawn

Conditions: Leukemia, Myelogenous, Chronic, BCR-ABL Positive

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

Study type: Observational

Funder types: Other

Identifiers

NCT02421926

H-99

Details and patient eligibility

About

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 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

0 participants in 1 patient group

IDEAL-E observational group

Description:

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.

Treatment:

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