LeukemiaPhase 3NCT01511289
Radotinib Versus Imatinib in Newly Diagnosed Philadelphia Chromosome and Chronic Myeloid Leukemia Chronic Phase Patients
A Phase 3 study testing Imatinib and Radotinib in people with Leukemia and Leukemia, Myeloid, run by Il-Yang Pharm. Co., Ltd. at 22 sites in 4 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Leukemia, Myeloid, Leukemia, Myelogenous, Chronic, BCR-ABL Positive
- What is being tested?
- Imatinib and Radotinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 22 sitesin 4 countries
- Study dates
- Aug 2011to Feb 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Patients with confirmed diagnosis of chronic phase CML within last 3 months
- Patients with cytogenetically confirmed Ph positive CML in early chronic phase
Who cannot join
- Patients with Philadelphia chromosome negative but BCR-ABL positive CML
- Patients who used imatinib for 8 days or longer before study entry
- Patients who had been treated with other targeted anti-cancer therapy, except for Hydrea or Agrylin, which inhibits the growth of leukemic cells
- Patients with impaired cardiac function
- Cytologically confirmed CNS involvement
- Severe or uncontrolled chronic medical condition
- Other significant congenital or acquired bleeding disorders that are not related to underlying leukemia
- Patients who had a major surgery within 4 weeks prior to study entry or has not recovered from side effects of such surgery
Trial locations and contacts
22 sites in 4 countries.
22 sites in 4 countries
South Korea18 sites
Local Institution
Busan, 602-715
Local Institution
Busan, 602-739
Local Institution
Busan, 633-165
Local Institution
Daegu, 700-712
Local Institution
Daejeon, 301-721
Local Institution
Gyeonggi-do, 431-070
Local Institution
Gyeonggi-do, 442-723
Local Institution
Gyeonggi-do, 443-721
Local Institution
Incheon, 405-760
Local Institution
Jeollabuk-do, 561-712
Local Institution
Jeonnam, 519-763
Local Institution
Seoul, 110-746
Local Institution
Seoul, 137-701
Local Institution
Seoul, 138-736
Local Institution
Seoul, 152-703
Local Institution
Seoul, 158-710
Local Institution
Ulsan, 682-714
Local Institution
Wŏnju, 220-701
About this study
Official title: A Phase 3 Multinational, Multi-center, Open-Label, Randomized Study of the Efficacy of Radotinib Versus Imatinib in Newly Diagnosed Ph+ CML Patients in Early Chronic Phase
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).
- Conditions
- Leukemia, Leukemia, Myeloid, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Philadelphia Chromosome, Bone Marrow Diseases, Hematologic Diseases
- Being tested
- Imatinib, Radotinib
- Keywords
- Radotinib, CML-CP, Chronic Myeloid Leukemia, chronic phase
- Medical subject headings
- Leukemia, Leukemia, Myeloid, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Philadelphia Chromosome, Bone Marrow Diseases, Hematologic Diseases, Leukemia, Myeloid, Chronic-Phase
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImatinibDrug
Also called Glivec, Gleevec
400mg/Tab, QD
RadotinibDrug
Also called IY5511HCl
100mg or 200mg/Capsule, 300mg or 400mg BID
| Study group | Role | What they receive |
|---|---|---|
| Imatinib | Active comparator | Imatinib 400mg QD Receives: Drug: Imatinib |
| Radotinib 600mg | Experimental | Radotinib 300mg BID Receives: Drug: Radotinib |
| Radotinib 800mg | Experimental | Radotinib 400mg BID Receives: Drug: Radotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (4)
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
Measured: 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.
Measured: 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.
Measured: 12 month
Rate of subjects with disease progression
Disease progression by month 12 will be compared between each groups.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2012 (estimated)
- Study startAug 2011
- Primary completionFeb 2015
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 LeukemiaStudies 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
- Masking
- None (open label)
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Il-Yang Pharm. Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- IL-YANG PHARM, Study director, IL-YANG Pharmaceutical. Co., LTD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01511289
- Sponsor's protocol ID
- IY5511A3001
- Status last verified
- Jan 2016
- First submitted
- 3 Jan 2012
- Last updated
- 24 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kwak JY, Kim SH, Oh SJ, Zang DY, Kim H, Kim JA, Do YR, Kim HJ, Park JS, Choi CW, Lee WS, Mun YC, Kong JH, Chung JS, Shin HJ, Kim DY, Park J, Jung CW, Bunworasate U, Comia NS, Jootar S, Reksodiputro AH, Caguioa PB, Lee SE, Kim DW. Phase III Clinical Trial (RERISE study) Results of Efficacy and Safety of Radotinib Compared with Imatinib in Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia. Clin Cancer Res. 2017 Dec 1;23(23):7180-7188. doi: 10.1158/1078-0432.CCR-17-0957. Epub 2017 Sep 22.
PubMed 28939746
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Multinational, Multi-center, Open-Label, Randomized Study of the Efficacy of Radotinib Versus Imatinib in Newly Diagnosed Ph+ CML Patients in Early Chronic Phase
- ClinicalTrials.gov ID
- NCT01511289
- Acronym / sponsor ID
- IY5511A3001
- Conditions
- Leukemia, Leukemia, Myeloid, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Philadelphia Chromosome, Bone Marrow Diseases, Hematologic Diseases
- Keywords
- Radotinib, CML-CP, Chronic Myeloid Leukemia, chronic phase
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Il-Yang Pharm. Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Feb 2015 (actual)
- First posted
- 18 Jan 2012 (estimated)
- 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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Imatinib | Active comparator | Drug: ImatinibImatinib 400mg QD |
| Radotinib 600mg | Experimental | Drug: RadotinibRadotinib 300mg BID |
| Radotinib 800mg | Experimental | Drug: RadotinibRadotinib 400mg BID |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with confirmed diagnosis of chronic phase CML within last 3 months
- Patients with cytogenetically confirmed Ph positive CML in early chronic phase
Key exclusion criteria (8 listed)
- Patients with Philadelphia chromosome negative but BCR-ABL positive CML
- Patients who used imatinib for 8 days or longer before study entry
- Patients who had been treated with other targeted anti-cancer therapy, except for Hydrea or Agrylin, which inhibits the growth of leukemic cells
- Patients with impaired cardiac function
- Cytologically confirmed CNS involvement
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 |
|---|---|---|
| ImatinibAlso: Glivec, Gleevec400mg/Tab, QD | Drug | Imatinib |
| RadotinibAlso: IY5511HCl100mg or 200mg/Capsule, 300mg or 400mg BID | Drug | Radotinib 600mg, Radotinib 800mg |
Primary outcome
Rate of Major Molecular Response(MMR) by 12 months
Time frame: 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.
4 secondary outcomes
Rate of complete cytogenetic response (CCyR) by 12 months
Time frame: 12 months
Rate of complete molecular response (CMR) by 12 months
Time frame: 12 months
Rate of major molecular response (MMR) at 12 months
Time frame: 12 month
Rate of subjects with disease progression
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2016.
- Derived from this study: PubMed 28939746Kwak JY, Kim SH, Oh SJ, Zang DY, Kim H, Kim JA, Do YR, Kim HJ, Park JS, Choi CW, Lee WS, Mun YC, Kong JH, Chung JS, Shin HJ, Kim DY, Park J, Jung CW, Bunworasate U, Comia NS, Jootar S, Reksodiputro AH, Caguioa PB, Lee SE, Kim DW. Phase III Clinical Trial (RERISE study) Results of Efficacy and Safety of Radotinib Compared with Imatinib in Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia. Clin Cancer Res. 2017 Dec 1;23(23):7180-7188. doi: 10.1158/1078-0432.CCR-17-0957. Epub 2017 Sep 22.
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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.
IL-YANG PHARM study director
IL-YANG Pharmaceutical. Co., LTD
22 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Imatinib and Radotinib in people with Leukemia and Leukemia, Myeloid, run by Il-Yang Pharm. Co., Ltd. at 22 sites in 4 countries.
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 2 inclusion and 8 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: finished, as of the sponsor's last update on 24 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in South Korea, Philippines, Indonesia, Thailand. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate of Major Molecular Response(MMR) by 12 months (time frame: 12 months). 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 NCT01511289, 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 24 Feb 2016.