MedTrace Logo

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

NCT03722420 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 238

Last updated 2024-10-28

No results posted yet for this study

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

Interventions

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).

DRUG

Imatinib

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

Sponsors & Collaborators

  • Il-Yang Pharm. Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Jiang Qian · Peking University People's Hospital(北京大学人民医院)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-28
Primary Completion
2023-03-03
Completion
2025-06-30

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03722420 on ClinicalTrials.gov