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 (Jun 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
Treatments studied
Targeted therapy
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.
Frequently asked questions
Is NCT03459534 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received BCR-ABL inhibitor.
Does this trial require BCR?
Yes, BCR fusion is a required biomarker for enrollment.
Does this trial require ABL1?
Yes, ABL1 fusion is a required biomarker for enrollment.
Are patients with BCR alterations eligible?
No. BCR T315I point mutation is an exclusion criterion.
Are patients with ABL1 alterations eligible?
No. ABL1 T315I point mutation is an exclusion criterion.
What disease stage is eligible?
Stage CHRONIC PHASE is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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