Clinical trial · Interventional
Radotinib Versus Imatinib in Newly Diagnosed Philadelphia Chromosome and Chronic Myeloid Leukemia Chronic Phase Patients
A Phase 3 Multinational, Multi-center, Open-Label, Randomized Study of the Efficacy of Radotinib Versus Imatinib in Newly Diagnosed Ph+ CML Patients in Early Chronic Phase
NCT01511289CI-TRIAL-00021074completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- 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)
In this study, the efficacy and safety of two radotinib doses, 300 mg twice daily and 400 mg twice daily, will be compared with imatinib 400 mg once daily in newly diagnosed patients with Philadelphia chromosome-positive (Ph+) Chronic Myelogenous Leukemia in the chronic phase (CML-CP).
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bone Marrow Diseases | — | UNRESOLVED | — |
| Hematologic Diseases | — | UNRESOLVED | — |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Leukemia, Myelogenous, Chronic, BCR-ABL Positive | Leukemia | ONTOLOGY_EXACT | 0.85 |
| Leukemia, Myeloid | Myeloid Leukemia | ALIAS | 0.90 |
| Philadelphia Chromosome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Imatinib | Drug | Imatinib | ALIAS |
| Radotinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Imatinib
- description
- Imatinib 400mg QD
- interventionNames
- Drug: Imatinib
- type
- EXPERIMENTAL
- label
- Radotinib 600mg
- description
- Radotinib 300mg BID
- interventionNames
- Drug: Radotinib
- type
- EXPERIMENTAL
- label
- Radotinib 800mg
- description
- Radotinib 400mg BID
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with confirmed diagnosis of chronic phase CML within last 3 months * Patients with cytogenetically confirmed Ph positive CML in early chronic phase Exclusion Criteria: * Patients with Philadelphia chromosome negative but BCR-ABL positive CML * Patients who used imatinib for 8 days or longer before study entry * Patients who had been treated with other targeted anti-cancer therapy, except for Hydrea or Agrylin, which inhibits the growth of leukemic cells * Patients with impaired cardiac function * Cytologically confirmed CNS involvement * Severe or uncontrolled chronic medical condition * Other significant congenital or acquired bleeding disorders that are not related to underlying leukemia * Patients who had a major surgery within 4 weeks prior to study entry or has not recovered from side effects of such surgery
References
Publications (1)
- DERIVEDKwak JY, Kim SH, Oh SJ, Zang DY, Kim H, Kim JA, Do YR, Kim HJ, Park JS, Choi CW, Lee WS, Mun YC, Kong JH, Chung JS, Shin HJ, Kim DY, Park J, Jung CW, Bunworasate U, Comia NS, Jootar S, Reksodiputro AH, Caguioa PB, Lee SE, Kim DW. Phase III Clinical Trial (RERISE study) Results of Efficacy and Safety of Radotinib Compared with Imatinib in Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia. Clin Cancer Res. 2017 Dec 1;23(23):7180-7188. doi: 10.1158/1078-0432.CCR-17-0957. Epub 2017 Sep 22. PMID 28939746