OncoMatch/Clinical Trials/NCT03459534
A Phase 3 Study for the Efficacy and Safety of Radotinib in CP-CML Patients With Failure or Intolerance to Previous TKIs
Is NCT03459534 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies Radotinib HCl for chronic myeloid leukemia, chronic phase.
Treatment: Radotinib HCl — In a multinational, multicenter, single-arm, open-label and Phase III Radotinib clinical study, chronic phase Ph+ chronic myeloid leukemia patients with failure or intolerance to previous TKIs therapy including Imatinib will be recruited. In this phase 3 study, 173 subjects are expected to be enrolled in a single arm with the administration of Radotinib 400mg twice daily, which includes 10% of dropout rate.
Check if I qualifyExtracted eligibility criteria
Cancer type
Chronic Myeloid Leukemia
Biomarker criteria
Required: BCR fusion
Philadelphia Chromosome Positive
Required: ABL1 fusion
Philadelphia Chromosome Positive
Excluded: BCR T315I point mutation
Patients with T315I point mutations
Excluded: ABL1 T315I point mutation
Patients with T315I point mutations
Disease stage
Required: Stage CHRONIC PHASE
Excluded: Stage ACCELERATED PHASE, BLAST CRISIS
Chronic phase is defined as all of the following conditions that subjects meet.
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: BCR-ABL inhibitor (imatinib)
patients who failed or intolerance the previous TKIs therapy including Imatinib
Lab requirements
Blood counts
Platelets count ≥50 × 10^9/L (≥ 50,000/mm3) (But, transient prior therapy related thrombocytopenia < 50 × 10^9/L (< 50,000/mm3) is acceptable)
Kidney function
Creatinine < 1.5 × ULN
Liver function
Total bilirubin < 1.5 × ULN; SGOT and SGPT < 2.5× ULN; Alkaline Phosphatase ≤ 2.5 × ULN (only if not related to the tumor)
Cardiac function
No impaired cardiac function (see exclusion criteria for details)
Patients who have adequate organ functions as defined below: Total bilirubin < 1.5 × ULN; SGOT and SGPT < 2.5× ULN; Creatinine < 1.5 × ULN; Serum amylase and lipase ≤ 1.5 × ULN; Alkaline Phosphatase ≤ 2.5 × ULN (only if not related to the tumor); Platelets count ≥50 × 10^9/L (≥ 50,000/mm3) (But, transient prior therapy related thrombocytopenia < 50 × 10^9/L (< 50,000/mm3) is acceptable); No impaired cardiac function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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