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

NCT03722420 | Active Not Recruiting Phase 3

• 1 other identifier: RT51CN03
• Study Type: interventional
• Target: 238
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Myeloid Leukemia, Chronic Phase

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• MMR rate

  by 3, 6, 9, and 12 months of treatment.

• Complete Cytogenetic Response(CCyR) rate

  by 3, 6, 9, and 12 months of treatment.

• The MR 4.0 and MR 4.5 rates

  by 3, 6, 9, and 12 months of treatment, and late

• Disease progression (AP/BC) rate

  at 3, 6, and 12 months

• Failure rate according to European Leukemia Net (ELN) guideline 2013 (ELN 2013*)

  at 3, 6, and 12 months

Study Arms (2)

Radotinib 300mg

EXPERIMENTAL

Oral adminstration of Radotinib 300mg BID (600mg/day) for 12months

Drug: Radotinib

Imatinib 400mg

ACTIVE COMPARATOR

Oral administration of Imatinib 400mg QD (400mg/day) for 12months

Drug: Imatinib

Interventions

Radotinib DRUG

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).

Also known as: Supect

Radotinib 300mg

Imatinib DRUG

Patients randomized to the imatinib 400 mg arm will receive imatinib once a day throughout the study.

Also known as: Glivec

Imatinib 400mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Il-Yang Pharm. Co., Ltd.: lead

Study Sites (1)

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

Beijing, 100044, China

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Chronic-Phase

Interventions

4-methyl-N-(3-(4-methylimidazol-1-yl)-5-trifluoromethylphenyl)-3-(4-pyrazin-2-ylpyrimidin-2-ylamino)benzamide; Imatinib Mesylate

Condition Hierarchy (Ancestors)

Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Jiang Qian

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel, 2 arms

Study Record Dates

• First Submitted: October 25, 2018
• First Posted: October 29, 2018
• Study Start: December 28, 2018
• Primary Completion: March 3, 2023
• Study Completion: June 30, 2025
• Last Updated: October 28, 2024

Record last verified: 2024-10

Locations

CN (1)