A Phase 3 Study for the Efficacy and Safety of Radotinib in CP-CML Patients With Failure or Intol… (NCT03459534) | Clinical Trial Compass
RecruitingPhase 3
A Phase 3 Study for the Efficacy and Safety of Radotinib in CP-CML Patients With Failure or Intolerance to Previous TKIs
Russia173 participantsStarted 2018-06-25
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male or female patients aged 18 years old
✓. Chronic Phase Ph+ Chronic Myeloid Leukemia patients who failed or intolerance the previous TKIs therapy including Imatinib Imatinib
✓. ECOG scale 0, 1 or 2
✓. Chronic phase is defined as all of the following conditions that subjects meet.
✓. Patients who have adequate organ functions as defined below:
✓. Women of childbearing potential should have a negative serum or urine pregnancy test within 14 days of the enrollment.
✓. Women of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and for a period of at least 1 month (4 weeks) after the last dose of investigational product in such a manner that the risk of pregnancy is minimized.
Exclusion criteria
✕. Patients who have been diagonised accelerated phase and blast crisis CML in previous therapy if only once.
✕. Patients with CCyR at the time of screening
✕. Any below impaired cardiac function:
✕. Patients with T315I point mutations
✕. Patients with central nervous system involvement as cytopathologically confirmed