A Phase 3 interventional study of Radotinib and Imatinib in Chronic Myeloid Leukemia, Chronic Phase, sponsored by Il-Yang Pharm. Co., Ltd.. Active, not recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by Il-Yang Pharm. Co., Ltd. · Phase 3, Interventional, and Treatment
This is a Phase III, multi-center, open-label, parallel, 2-arm, randomized study to evaluate the efficacy and safety of radotinib 300 mg Bis In Die(BID) versus imatinib 400 mg Quaque Die(QD).
This study will be conducted in Chinese patients with newly diagnosed Ph+ Chronic Myelogenous Leukemia(CML)-Chronic Phase(CP) who are previously untreated for Chronic Myelogenous Leukemia(CML).
Patients randomized to the radotinib arms will receive 300 mg of radotinib BID at approximately 12-hour intervals. Patients randomized to the imatinib 400 mg arm will receive imatinib once a day throughout the study.
The primary efficacy endpoint is the rate of Major Molecular Response(MMR) at 12 months (1 month = 4 weeks = 28 days), defined as BCR ABL1/ABL% ≤ 0.1% by international scale. The Molecular Response(MR) rate will be measured every 3 months by Real-time Quantitative(RQ)-Polymerase Chain Reaction(PCR) in a central laboratory. All patients will be treated and/or followed for 12 months (48 weeks) after randomization.
439 studies on the registry are indexed under Leukemia, Myeloid, Chronic-Phase; 27 are open to participants now.
This study's planned enrollment of 238 is above the median of 43 across 322 interventional studies indexed under Leukemia, Myeloid, Chronic-Phase.
Browse Leukemia, Myeloid, Chronic-Phase studies →Il-Yang Pharm. Co., Ltd. is the lead sponsor of 34 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Oral adminstration of Radotinib 300mg BID (600mg/day) for 12months
Drug: Radotinib
Oral administration of Imatinib 400mg QD (400mg/day) for 12months
Drug: Imatinib
Patients randomized to the radotinib arms will receive 300 mg of radotinib BID (1 in the morning and 1 in the evening, at approximately 12-hour intervals).
Also known as: Supect
Patients randomized to the imatinib 400 mg arm will receive imatinib once a day throughout the study.
Also known as: Glivec
The MMR rate
The MMR rate at 12 months after radotinib or imatinib treatment in patients with newly diagnosed CML-CP.
Time frame: at 12 months after radotinib or imatinib treatment
MMR rate
To compare MMR rate for the best response in patients within specific periods.
Time frame: by 3, 6, 9, and 12 months of treatment.
Complete Cytogenetic Response(CCyR) rate
To compare CCyR rate for the best response in patients within specific periods.
Time frame: by 3, 6, 9, and 12 months of treatment.
The MR 4.0 and MR 4.5 rates
To compare the MR4.0 and MR4.5 rates for the best response in patients within specific periods.
Time frame: by 3, 6, 9, and 12 months of treatment, and late
Disease progression (AP/BC) rate
To compare disease progression for the best response in patients within specific periods.
Time frame: at 3, 6, and 12 months
Failure rate according to European Leukemia Net (ELN) guideline 2013 (ELN 2013*)
To compare failure rate for the best response in patients within specific periods.
Time frame: at 3, 6, and 12 months
Plan to share: Undecided
Ran from Dec 2018 to primary completion in Mar 2023, 50 months.
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This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Radotinib
Leukemia, Myeloid, Chronic-Phase →