Leukemia, Myelogenous, Chronic, BCR-ABL Positive Clinical Trial
— IDEAL-EOfficial title:
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
NCT number | NCT02421926 |
Other study ID # | H-99 |
Secondary ID | |
Status | Withdrawn |
Phase | |
First received | |
Last updated | |
Start date | October 2014 |
Est. completion date | May 2023 |
Verified date | July 2019 |
Source | Asan Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | May 2023 |
Est. primary completion date | May 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
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(GlinibĀ®) 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(GlinibĀ®) 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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Korea University Ansan Hospital | Ansan | |
Korea, Republic of | Busan National University Hospital | Busan | |
Korea, Republic of | Haeundae Paik Hospital | Busan | |
Korea, Republic of | Chungnam National University Hospital | Daejeon | |
Korea, Republic of | Gachon University Gil Hospital | Incheon | |
Korea, Republic of | Seoul National University Bundang Hospital | Seongnam | Gyong-gi Province |
Korea, Republic of | Asan Medical Center | Seoul | |
Korea, Republic of | Korea University Anam Hospital | Seoul | |
Korea, Republic of | Korea University Guro Hospital | Seoul | |
Korea, Republic of | Seoul National University Hospital | Seoul | |
Korea, Republic of | Soonchyunhyang University Hospital | Seoul | |
Korea, Republic of | Ajou University Hospital | Suwon |
Lead Sponsor | Collaborator |
---|---|
Asan Medical Center |
Korea, Republic of,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | cumulative incidence of hematologic adverse events | 2-year | ||
Other | cumulative incidence of hematologic adverse events | 5-year | ||
Other | cumulative incidence of non-hematologic adverse events | 2-year | ||
Other | cumulative incidence of non-hematologic adverse events | 5-year | ||
Primary | progression-free survival rate | 5-year | ||
Secondary | failure-free survival rate | 2-year | ||
Secondary | failure-free survival rate | 5-year | ||
Secondary | cumulative incidence of progression to accelerated phase / blast crisis | 2-year | ||
Secondary | cumulative incidence of progression to accelerated phase / blast crisis | 5-year | ||
Secondary | overall survival | 2-year | ||
Secondary | overall survival | 5-year | ||
Secondary | progression-free survival rate | 2-year |
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