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

NCT02421926 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2019-07-08

No results posted yet for this study

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.

Conditions

  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive

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.

Sponsors & Collaborators

  • Asan Medical Center

    lead OTHER

Principal Investigators

  • Kyoo-Hyung Lee, MD, PhD · Asan Medical Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2023-05-31
Completion
2023-05-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02421926 on ClinicalTrials.gov