Description:
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).
Title
- Brief Title: Randomized Evaluation of Radotinib Versus Imatinib in Phase III Study for Efficacy With Chinese Patients (RERISE China)
- 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
Clinical Trial IDs
- ORG STUDY ID:
RT51CN03
- NCT ID:
NCT03722420
Conditions
- Chronic Myeloid Leukemia, Chronic Phase
Interventions
Drug | Synonyms | Arms |
---|
Radotinib | Supect | Radotinib 300mg |
Imatinib | Glivec | Imatinib 400mg |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Radotinib 300mg | Experimental | Oral adminstration of Radotinib 300mg BID (600mg/day) for 12months | |
Imatinib 400mg | Active Comparator | Oral administration of Imatinib 400mg QD (400mg/day) for 12months | |
Eligibility Criteria
Inclusion Criteria:
1. China who are 18 years of age or older.
2. Eastern cooperative oncology group (ECOG) score 0, 1, or 2.
3. Patients with confirmed diagnosis of CML-CP within last 6 months.
4. Patients with cytogenetically confirmed Ph+ CML in chronic phase
5. Patients with typical BCR-ABL1 transcript type such as b2a2 and b3a2.
6. Patients with adequate organ function.
7. Women of childbearing potential should have negative serum or urine pregnancy test
within 14 days before study entry.
8. Patients providing written informed consent before initiation of any study-related
activities.
Exclusion Criteria:
1. Patients with Philadelphia chromosome negative but BCR-ABL1 positive CML.
2. Patients who had been treated with interferon or other targeted anti-cancer therapy
which inhibits the growth of leukemic cells
3. Concurrently clinically significant primary malignancy
4. Patients who previously received radiotherapy
5. Patients with impaired cardiac function.
6. uncontrolled chronic medical condition
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | The MMR rate |
Time Frame: | at 12 months after radotinib or imatinib treatment |
Safety Issue: | |
Description: | The MMR rate at 12 months after radotinib or imatinib treatment in patients with newly diagnosed CML-CP. |
Secondary Outcome Measures
Measure: | MMR rate |
Time Frame: | by 3, 6, 9, and 12 months of treatment. |
Safety Issue: | |
Description: | To compare MMR rate for the best response in patients within specific periods. |
Measure: | Complete Cytogenetic Response(CCyR) rate |
Time Frame: | by 3, 6, 9, and 12 months of treatment. |
Safety Issue: | |
Description: | To compare CCyR rate for the best response in patients within specific periods. |
Measure: | The MR 4.0 and MR 4.5 rates |
Time Frame: | by 3, 6, 9, and 12 months of treatment, and late |
Safety Issue: | |
Description: | To compare the MR4.0 and MR4.5 rates for the best response in patients within specific periods. |
Measure: | Disease progression (AP/BC) rate |
Time Frame: | at 3, 6, and 12 months |
Safety Issue: | |
Description: | To compare disease progression for the best response in patients within specific periods. |
Measure: | Failure rate according to European Leukemia Net (ELN) guideline 2013 (ELN 2013*) |
Time Frame: | at 3, 6, and 12 months |
Safety Issue: | |
Description: | To compare failure rate for the best response in patients within specific periods. |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Il-Yang Pharm. Co., Ltd. |
Last Updated
December 21, 2020