Randomized Evaluation of Radotinib Versus Imatinib in Phase III Study for Efficacy With Chinese Patients (RERISE China)

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Myeloid Leukemia, Chronic Phase
• Intervention / Treatment: Drug: Radotinib; Drug: Imatinib

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 Type: Interventional
• Enrollment (Estimated): 238
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100044
    • Peking University People's Hospital(北京大学人民医院)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Radotinib 300mg; Oral adminstration of Radotinib 300mg BID (600mg/day) for 12months	Drug: Radotinib; 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).; Other Names: Supect
Active Comparator: Imatinib 400mg; Oral administration of Imatinib 400mg QD (400mg/day) for 12months	Drug: Imatinib; Patients randomized to the imatinib 400 mg arm will receive imatinib once a day throughout the study.; Other Names: Glivec

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The MMR rate	The MMR rate at 12 months after radotinib or imatinib treatment in patients with newly diagnosed CML-CP.	at 12 months after radotinib or imatinib treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MMR rate	To compare MMR rate for the best response in patients within specific periods.	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.	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.	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.	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.	at 3, 6, and 12 months

Collaborators and Investigators

• Sponsor: Il-Yang Pharm. Co., Ltd.
• Investigators: Principal Investigator: Jiang Qian, Peking University People's Hospital(北京大学人民医院)

Study record dates

Study Major Dates

• Study Start (Actual): December 28, 2018
• Primary Completion (Actual): March 3, 2023
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: October 25, 2018
• First Submitted That Met QC Criteria: October 25, 2018
• First Posted (Actual): October 29, 2018

Study Record Updates

• Last Update Posted (Estimated): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Disease Attributes; Bone Marrow Diseases; Hematologic Diseases; Myeloproliferative Disorders; Chronic Disease; Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Tyrosine Kinase Inhibitors; Imatinib Mesylate
• Other Study ID Numbers: RT51CN03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No