Clinical trial · Interventional
Radotinib as 3rd or Later Line Therapy in CP-CML
Radotinib Efficacy and Safety Validation in Chronic Phase Chronic Myeloid Leukemia Patients Who Are Intolerant or Resistant to at Least Two Tyrosine Kinase Inhibitors As a Third or Subsequent Line Therapy
NCT02422719CI-TRIAL-00022084REVITALunknownPhase 2ClinicalTrials.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)
The purpose of this study is to determine whether radotinib is effective and safe for patients with chronic myeloid leukemia, chronic phase who are intolerable or resistant to prior 2 or more tyrosine kinase inhibitors.
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 Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radotinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Radotinib
- description
- Radotinib treatement single arm
- interventionNames
- Drug: Radotinib
Primary outcomes (1)
- measure
- Rate of Major cytogenetic response
- timeFrame
- by 12 months after radotinib treatment
- description
- The rate of achieving major cytogenetic response \[35% or less t(9;22) chromosome by conventional banding technique\] in bone marrow by 12 months after radotinib treatment will be the primary end point.
Secondary outcomes (2)
- measure
- Rate of Major Molecular response (MR3.0) on each time point
- timeFrame
- up to 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Chronic myeloid leukemia chronic phase (CP-CML) patients who are not tolerable or resistant to prior 2 or more tyrosine kinase inhibitors (TKIs). * ECOG 0, 1, 2 * Patients who are agree and signed to informed consent. Exclusion Criteria: * T315I mutation * Prior exposure to radotinib * Accelerated or blastic phase * galactose intolerance, severe lactase deficiency or glucose galactose malabsorption * Prior history of intensive cytotoxic chemotherapy except for TKIs * Significant cardiac problem * QTcF \> 450 msec * Pancreatitis history prior to study enrollment * Clinically significant malignant disease other than CML * Pregnant or breast feeding woman
References
Publications (0)
Data not yet available
No reference posted for this study.