NCT03722420Active, not recruitingPhase 3
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
Source: ClinicalTrials.gov · Last updated 3 Sept 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 238 (estimated)
- First submitted
- 25 Oct 2018
- Start date
- 28 Dec 2018
- Primary completion date
- 3 Mar 2023
- Lead sponsor
- Il-Yang Pharm. Co., Ltd.
- Diseases
- Chronic myeloid leukaemia
- NCT number
- NCT03722420
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 238
- From 28 Dec 2018 to the primary completion date, 3 Mar 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who had been treated with interferon or other targeted anti-cancer therapy which inhibits the growth of leukemic cells
- Patients who previously received radiotherapy
Other illness
- Concurrently clinically significant primary malignancy
- Patients with impaired cardiac function.
- uncontrolled chronic medical condition
Other
- Patients with Philadelphia chromosome negative but BCR-ABL1 positive CML.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University People's Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
Related publications
- Clinical pharmacokinetic characteristics and the food effect of radotinib.Invest New Drugs · 2026 · PMID 41894126
This page is information, not medical advice. Discuss any trial with your doctor.