A Study to Evaluate Efficacy and Safety of Glinib in Newly Diagnosed CML Patients (IDEAL)
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|ClinicalTrials.gov Identifier: NCT02204722|
Recruitment Status : Terminated (Sponsor's decision to halt the study.)
First Posted : July 30, 2014
Last Update Posted : June 15, 2018
|Condition or disease||Intervention/treatment||Phase|
|Chronic Myeloid Leukemia||Drug: 600mg/day of Imatinib Drug: 400mg/day of Imatinib||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||55 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||October 13, 2014|
|Actual Primary Completion Date :||May 23, 2017|
|Actual Study Completion Date :||January 9, 2018|
Experimental: Group B
the group who has more than 10% of the BCR-ABL(IS) level for three months will receive 600mg/day of Imatinib after three months.
Drug: 600mg/day of Imatinib
Experimental: Group A
the group who has more than 10% of the BCR-ABL(IS) level for three months will maintain the dose, 400mg/day of Imatinib, after three months.
Drug: 400mg/day of Imatinib
- MMR rate at 12 months in two groups [ Time Frame: 12 months ]MMR rate at 12 months in two groups will be compared. Group A is consisted of patients with equal or less than 10% of BDR-ABL, Group B is consisted of patients with more than 10% of BDR-ABL.
- CCyR in group A and B [ Time Frame: 12 months ]CCyR rate for 12 months and the duration of the complete CCyR will be evaluated.
- MMR in group A and B [ Time Frame: 12 months ]MMR rate for 12 months and the duration of MMR will be measured.
- CMR in group A and B [ Time Frame: 12 months ]
- Survival rate in group A and B [ Time Frame: 12 months ]
- Progression rate to AP/BC in group A and B [ Time Frame: 12 months ]
- the actual administration [ Time Frame: 12 months ]the total dose will be divided by total days of the treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02204722
|Korea, Republic of|
|Asan Medical Center|
|Seoul, Korea, Republic of, 138736|
|Principal Investigator:||Kyu-Hyoung Lee, M.D.||Asan Medical Center|
|Principal Investigator:||Jin-hee Park, M.D.||Gachon University Gil Medical Center|
|Principal Investigator:||Chul-won Choi, M.D.||Korea University Guro Hospital|
|Principal Investigator:||Sae-ryun Lee, M.D.||Korea University|
|Principal Investigator:||Yong Park, M.D.||Korea University Anam Hospital|
|Principal Investigator:||Joo-sup Joeng, M.D.||Pusan National University Hospital|
|Principal Investigator:||Jung-ok Lee, M.D.||Seoul National University Bundang Hospital|
|Principal Investigator:||Chul-won Jung, M.D.||Seoul Medical Center|
|Principal Investigator:||Sung-soo Yoon, M.D.||Seoul National University Hospital|
|Principal Investigator:||Kyung-ha Kim, M.D.||Soonchunhyang University Hospital Seoul|
|Principal Investigator:||Joon-sung Park, M.D.||Ajou University School of Medicine|
|Principal Investigator:||Duk-yeon Cho, M.D.||Chungnam National University Hospital|
|Principal Investigator:||Sung-nam Im, M.D.||Inje University|