A Phase 3 interventional study of Imatinib and Radotinib in Leukemia, Leukemia, Myeloid and Leukemia, Myelogenous, Chronic, BCR-ABL Positive, sponsored by Il-Yang Pharm. Co., Ltd.. Completed at 22 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-02-24.
Sponsored by Il-Yang Pharm. Co., Ltd. · Phase 3, Interventional, and Treatment
In this study, the efficacy and safety of two radotinib doses, 300 mg twice daily and 400 mg twice daily, will be compared with imatinib 400 mg once daily in newly diagnosed patients with Philadelphia chromosome-positive (Ph+) Chronic Myelogenous Leukemia in the chronic phase (CML-CP).
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 242 is above the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →Il-Yang Pharm. Co., Ltd. is the lead sponsor of 31 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Imatinib 400mg QD
Drug: Imatinib
Radotinib 300mg BID
Drug: Radotinib
Radotinib 400mg BID
Drug: Radotinib
400mg/Tab, QD
Also known as: Glivec, Gleevec
100mg or 200mg/Capsule, 300mg or 400mg BID
Also known as: IY5511HCl
Rate of Major Molecular Response(MMR) by 12 months
Rate of Major Molecular Response (MMR) at Any Time within 12 months. MMR by 12 months will be assessed as responder if the patient has response at any time within 12 months. A major molecular response rate is defined as the ratio (%) of BCR-ABL/ABL ≤ 0.1% by international scale or a 3-log reduction in BCR-ABL transcript level from standardized baseline, as measured by standardized RQ-PCR assay.
Time frame: 12 months
Rate of complete cytogenetic response (CCyR) by 12 months
Complete cytogenetic response is defined as complete disappearance of Philadelphia-positive in at least 20 metaphases examined. Chromosome analysis performed on less than 20 metaphases will not be accepted for this study
Time frame: 12 months
Rate of complete molecular response (CMR) by 12 months
Complete molecular response is defined as negative BCR-ABL transcript levels, as measured twice by the internationally standardized RQ-PCR assay. The rate of complete molecular response by cycle 12 is defined as an at least 4.5 log reduction in BCR-ABL transcript levels from standardized baseline or BCR-ABL/ABL % ≤ 0.005% by the international scale.
Time frame: 12 months
Rate of major molecular response (MMR) at 12 months
Rate of Major Molecular response will be assessed at 12 months at that timepoint. Number of Participants With Major Molecular Response (MMR) at 12 months.
Time frame: 12 month
Rate of subjects with disease progression
Disease progression by month 12 will be compared between each groups.
Time frame: 12 months
This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
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Il-Yang Pharm. Co., Ltd.