← Back to all trials
Recruiting
NCT03459534
A Phase 3 Study for the Efficacy and Safety of Radotinib in CP-CML Patients With Failure or Intolerance to Previous TKIs
Conditions: Chronic Myeloid Leukemia, Chronic Phase, CML, Chronic Phase, CML, Refractory, CML - Philadelphia Chromosome
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 173
Sponsor: Il-Yang Pharm. Co., Ltd.
Location: Territorial State Budgetary Institution Barnaul
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.
Eligibility Criteria
Inclusion Criteria:
1. Male or female patients aged 18 years old
2. Chronic Phase Ph+ Chronic Myeloid Leukemia patients who failed or intolerance the previous TKIs therapy including Imatinib Imatinib
3. ECOG scale 0, 1 or 2
4. Chronic phase is defined as all of the following conditions that subjects meet.
* Blast in peripheral blood and bone marrow \
Source: ClinicalTrials.gov (NCT03459534). StuddyBuddy aggregates publicly available trial information.
