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

• ClinicalTrials.gov Identifier: NCT03722420
• Recruitment Status: Active, not recruiting
• First Posted: October 29, 2018
• Last Update Posted: January 4, 2022
• Sponsor: Il-Yang Pharm. Co., Ltd.
• Information provided by (Responsible Party): Il-Yang Pharm. Co., Ltd.

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).

Condition or disease	Intervention/treatment	Phase
Chronic Myeloid Leukemia, Chronic Phase	Drug: Radotinib; Drug: Imatinib	Phase 3

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

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 238 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Parallel, 2 arms
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: December 28, 2018
• Estimated Primary Completion Date: December 31, 2023
• Estimated Study Completion Date: December 31, 2023

Arms and Interventions

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 Name: 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 Name: Glivec

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. MMR rate [ Time Frame: by 3, 6, 9, and 12 months of treatment. ]
   To compare MMR rate for the best response in patients within specific periods.
2. Complete Cytogenetic Response(CCyR) rate [ Time Frame: by 3, 6, 9, and 12 months of treatment. ]
   To compare CCyR rate for the best response in patients within specific periods.
3. The MR 4.0 and MR 4.5 rates [ Time Frame: by 3, 6, 9, and 12 months of treatment, and late ]
   To compare the MR4.0 and MR4.5 rates for the best response in patients within specific periods.
4. Disease progression (AP/BC) rate [ Time Frame: at 3, 6, and 12 months ]
   To compare disease progression for the best response in patients within specific periods.
5. Failure rate according to European Leukemia Net (ELN) guideline 2013 (ELN 2013*) [ Time Frame: at 3, 6, and 12 months ]
   To compare failure rate for the best response in patients within specific periods.

Eligibility Criteria

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

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

Contacts and Locations

Locations

China

Peking University People's Hospital(北京大学人民医院)

Beijing, China, 100044

Sponsors and Collaborators

Il-Yang Pharm. Co., Ltd.

Investigators

• Principal Investigator: Jiang Qian; Peking University People's Hospital(北京大学人民医院)

More Information

• Responsible Party: Il-Yang Pharm. Co., Ltd.
• ClinicalTrials.gov Identifier: NCT03722420
• Other Study ID Numbers: RT51CN03
• First Posted: October 29, 2018
• Last Update Posted: January 4, 2022
• Last Verified: January 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Imatinib Mesylate; Antineoplastic Agents; Protein Kinase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action