Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Myeloid Leukemia, Chronic Phase | Chronic Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Imatinib | Drug | Imatinib | ALIAS |
| Radotinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Radotinib 300mg
- description
- Oral adminstration of Radotinib 300mg BID (600mg/day) for 12months
- interventionNames
- Drug: Radotinib
- type
- ACTIVE_COMPARATOR
- label
- Imatinib 400mg
- description
- Oral administration of Imatinib 400mg QD (400mg/day) for 12months
- interventionNames
- Drug: Imatinib
Primary outcomes (1)
- measure
- The MMR rate
- timeFrame
- at 12 months after radotinib or imatinib treatment
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDLee Y, Kim J, Kang M, Han J, Kim NY, Shin JS, Park MS, Jiang Q, Lee JI. Clinical pharmacokinetic characteristics and the food effect of radotinib. Invest New Drugs. 2026 Apr;44(2):187-195. doi: 10.1007/s10637-026-01610-6. Epub 2026 Mar 27. PMID 41894126