Chronic Myeloid Leukemia, Chronic PhasePhase 3NCT03722420
Randomized Evaluation of Radotinib Versus Imatinib in Phase III Study for Efficacy With Chinese Patients (RERISE China)
A Phase 3 study testing Radotinib and Imatinib in people with Chronic Myeloid Leukemia, Chronic Phase, run by Il-Yang Pharm. Co., Ltd. at 1 site in China.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Myeloid Leukemia, Chronic Phase
- What is being tested?
- Radotinib and Imatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 238 participants
- Where
- 1 siteChina
- Study dates
- 28 Dec 2018to 31 Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- China who are 18 years of age or older.
- Eastern cooperative oncology group (ECOG) score 0, 1, or 2.
- Patients with confirmed diagnosis of CML-CP within last 6 months.
- Patients with cytogenetically confirmed Ph+ CML in chronic phase
- Patients with typical BCR-ABL1 transcript type such as b2a2 and b3a2.
- Patients with adequate organ function.
- Women of childbearing potential should have negative serum or urine pregnancy test within 14 days before study entry.
- Patients providing written informed consent before initiation of any study-related activities.
Who cannot join
- Patients with Philadelphia chromosome negative but BCR-ABL1 positive CML.
- Patients who had been treated with interferon or other targeted anti-cancer therapy which inhibits the growth of leukemic cells
- Concurrently clinically significant primary malignancy
- Patients who previously received radiotherapy
- Patients with impaired cardiac function.
- uncontrolled chronic medical condition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase III, Multi-center, Open-Label, Randomized Study of the Efficacy of Radotinib Versus Imatinib in Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myeloid Leukemia Chinese Patients in Chronic Phase
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).
Read the detailed description
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.
- Conditions
- Chronic Myeloid Leukemia, Chronic Phase
- Being tested
- Radotinib, Imatinib
- Medical subject headings
- Leukemia, Myeloid, Chronic-Phase
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadotinibDrug
Also called Supect
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).
ImatinibDrug
Also called Glivec
Patients randomized to the imatinib 400 mg arm will receive imatinib once a day throughout the study.
| Study group | Role | What they receive |
|---|---|---|
| Radotinib 300mg | Experimental | Oral adminstration of Radotinib 300mg BID (600mg/day) for 12months Receives: Drug: Radotinib |
| Imatinib 400mg | Active comparator | Oral administration of Imatinib 400mg QD (400mg/day) for 12months Receives: Drug: Imatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
The MMR rate
The MMR rate at 12 months after radotinib or imatinib treatment in patients with newly diagnosed CML-CP.
Measured: at 12 months after radotinib or imatinib treatment
Secondary outcomes (5)
MMR rate
To compare MMR rate for the best response in patients within specific periods.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at 3, 6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2018
- Study start28 Dec 2018
- Primary completion3 Mar 2023
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Myeloid Leukemia, Chronic PhaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel, 2 arms
- Masking
- None (open label)
- Enrolment
- 238 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Il-Yang Pharm. Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jiang Qian, Principal investigator, Peking University People's Hospital(北京大学人民医院)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03722420
- Sponsor's protocol ID
- RT51CN03
- Status last verified
- Sep 2026
- First submitted
- 25 Oct 2018
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lee Y, Kim J, Kang M, Han J, Kim NY, Shin JS, Park MS, Jiang Q, Lee JI. Clinical pharmacokinetic characteristics and the food effect of radotinib. Invest New Drugs. 2026 Apr;44(2):187-195. doi: 10.1007/s10637-026-01610-6. Epub 2026 Mar 27.
PubMed 41894126
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multi-center, Open-Label, Randomized Study of the Efficacy of Radotinib Versus Imatinib in Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myeloid Leukemia Chinese Patients in Chronic Phase
- ClinicalTrials.gov ID
- NCT03722420
- Acronym / sponsor ID
- RT51CN03
- Conditions
- Chronic Myeloid Leukemia, Chronic Phase
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 238 participants (estimated)
- Lead sponsor
- Il-Yang Pharm. Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Dec 2018 (actual)
- Primary completion
- 3 Mar 2023 (actual)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 29 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel, 2 arms
| Arm | Type | Receives |
|---|---|---|
| Radotinib 300mg | Experimental | Drug: RadotinibOral adminstration of Radotinib 300mg BID (600mg/day) for 12months |
| Imatinib 400mg | Active comparator | Drug: ImatinibOral administration of Imatinib 400mg QD (400mg/day) for 12months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- China who are 18 years of age or older.
- Eastern cooperative oncology group (ECOG) score 0, 1, or 2.
- Patients with confirmed diagnosis of CML-CP within last 6 months.
- Patients with cytogenetically confirmed Ph+ CML in chronic phase
- Patients with typical BCR-ABL1 transcript type such as b2a2 and b3a2.
Key exclusion criteria (6 listed)
- Patients with Philadelphia chromosome negative but BCR-ABL1 positive CML.
- Patients who had been treated with interferon or other targeted anti-cancer therapy which inhibits the growth of leukemic cells
- Concurrently clinically significant primary malignancy
- Patients who previously received radiotherapy
- Patients with impaired cardiac function.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RadotinibAlso: SupectPatients 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). | Drug | Radotinib 300mg |
| ImatinibAlso: GlivecPatients randomized to the imatinib 400 mg arm will receive imatinib once a day throughout the study. | Drug | Imatinib 400mg |
Primary outcome
The MMR rate
Time frame: at 12 months after radotinib or imatinib treatment
The MMR rate at 12 months after radotinib or imatinib treatment in patients with newly diagnosed CML-CP.
5 secondary outcomes
MMR rate
Time frame: by 3, 6, 9, and 12 months of treatment.
Complete Cytogenetic Response(CCyR) rate
Time frame: by 3, 6, 9, and 12 months of treatment.
The MR 4.0 and MR 4.5 rates
Time frame: by 3, 6, 9, and 12 months of treatment, and late
Disease progression (AP/BC) rate
Time frame: at 3, 6, and 12 months
Failure rate according to European Leukemia Net (ELN) guideline 2013 (ELN 2013*)
Time frame: at 3, 6, and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Derived from this study: PubMed 41894126Lee Y, Kim J, Kang M, Han J, Kim NY, Shin JS, Park MS, Jiang Q, Lee JI. Clinical pharmacokinetic characteristics and the food effect of radotinib. Invest New Drugs. 2026 Apr;44(2):187-195. doi: 10.1007/s10637-026-01610-6. Epub 2026 Mar 27.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiang Qian principal investigator
Peking University People's Hospital(北京大学人民医院)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Radotinib and Imatinib in people with Chronic Myeloid Leukemia, Chronic Phase, run by Il-Yang Pharm. Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The MMR rate (time frame: at 12 months after radotinib or imatinib treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03722420, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.