Back to resultsRandomized Evaluation of Radotinib Versus Imatinib in Phase III Study for Efficacy With Chinese Patients (RERISE China)
Primary Purpose
Chronic Myeloid Leukemia, Chronic Phase
Status
Active
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Radotinib
Imatinib
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Myeloid Leukemia, Chronic Phase
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- Peking University People's Hospital(北京大学人民医院)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Radotinib 300mg
Imatinib 400mg
Arm Description
Oral adminstration of Radotinib 300mg BID (600mg/day) for 12months
Oral administration of Imatinib 400mg QD (400mg/day) for 12months
Outcomes
Primary Outcome Measures
The MMR rate
The MMR rate at 12 months after radotinib or imatinib treatment in patients with newly diagnosed CML-CP.
Secondary Outcome Measures
MMR rate
To compare MMR rate for the best response in patients within specific periods.
Complete Cytogenetic Response(CCyR) rate
To compare CCyR rate for the best response in patients within specific periods.
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.
Disease progression (AP/BC) rate
To compare disease progression for the best response in patients within specific periods.
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.
Full Information
NCT ID
NCT03722420
First Posted
October 25, 2018
Last Updated
September 26, 2023
Sponsor
Il-Yang Pharm. Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03722420
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 28, 2018 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Il-Yang Pharm. Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Myeloid Leukemia, Chronic Phase
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Parallel, 2 arms
Masking
None (Open Label)
Allocation
Randomized
Enrollment
238 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Radotinib 300mg
Arm Type
Experimental
Arm Description
Oral adminstration of Radotinib 300mg BID (600mg/day) for 12months
Arm Title
Imatinib 400mg
Arm Type
Active Comparator
Arm Description
Oral administration of Imatinib 400mg QD (400mg/day) for 12months
Intervention Type
Drug
Intervention Name(s)
Radotinib
Other Intervention Name(s)
Supect
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Imatinib
Other Intervention Name(s)
Glivec
Intervention Description
Patients randomized to the imatinib 400 mg arm will receive imatinib once a day throughout the study.
Primary Outcome Measure Information:
Title
The MMR rate
Description
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
Secondary Outcome Measure Information:
Title
MMR rate
Description
To compare MMR rate for the best response in patients within specific periods.
Time Frame
by 3, 6, 9, and 12 months of treatment.
Title
Complete Cytogenetic Response(CCyR) rate
Description
To compare CCyR rate for the best response in patients within specific periods.
Time Frame
by 3, 6, 9, and 12 months of treatment.
Title
The MR 4.0 and MR 4.5 rates
Description
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
Title
Disease progression (AP/BC) rate
Description
To compare disease progression for the best response in patients within specific periods.
Time Frame
at 3, 6, and 12 months
Title
Failure rate according to European Leukemia Net (ELN) guideline 2013 (ELN 2013*)
Description
To compare failure rate for the best response in patients within specific periods.
Time Frame
at 3, 6, and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiang Qian
Organizational Affiliation
Peking University People's Hospital(北京大学人民医院)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University People's Hospital(北京大学人民医院)
City
Beijing
ZIP/Postal Code
100044
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Randomized Evaluation of Radotinib Versus Imatinib in Phase III Study for Efficacy With Chinese Patients (RERISE China)
We'll reach out to this number within 24 hrs