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Report for Clinical Trial NCT03459534

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase 3 Multinational, Multi-center, Single-arm, Open-label Study for the Efficacy and Safety of Radotinib in Ph+ Chronic Phase Chronic Myeloid Leukemia Patients With Failure or Intolerance to Previous TKIs Therapy Including Imatinib

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.

NCT03459534 Leukemia, Myeloid, Chronic Phase
MeSH:Leukemia Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid, Chronic-Phase
HPO:Chronic myelogenous leukemia Leukemia Myeloid leukemia

1 Interventions

Name: Radotinib HCl

Description: Brand name/manufacturer: Supect Cap./IL-YANG PHARM. Co., Ltd. Active ingredient: radotinib HCl 106.8mg (100mg as radotinib) or HCl 213.6mg (200mg as radotinib) Appearance and formulation: hard capsule with a light blue cap and a body containing pale yellow powder Storage conditions: Store in an airtight light proof container at room temperature.
Type: Drug
Group Labels: 1

Radotinib HCl


Primary Outcomes

Description: MCyR is defined as 0~35% CCyR+PCyR based on ≥20 metaphase myelocytes. Chromosome test results from <20 metaphase myelocytes will be excluded from the analysis.

Measure: Major Cytogenetic Response (MCyR)

Time: at month 6

Secondary Outcomes

Description: CCyR is defined as complete loss of Ph chromosome based on ≥20 metaphase myelocytes. Chromosome test results from <20 metaphase myelocytes will be excluded from the analysis.

Measure: Cytogenetic Response (CCyR)

Time: at month 12/24, by month 24

Description: MMR is defined as a ≥3-log reduction in BCR-ABL1 transcript level from the standardized reference or BCR-ABL1/ABL % of ≤0.1% according to the international reference when the level of BCR-ABL1 gene was measured by RQ-PCR, a standardized quantitative genetic method.

Measure: Major molecular response

Time: at month 12/24, by month 24

Description: OS is defined as the duration from the first day of Radotinib administration to the day of death for certain causes.

Measure: Overall Survival(OS)

Time: by month 24

Description: PFS is defined as the duration from the first day of Radotinib administration to the earliest day of disease progression or death for certain causes.

Measure: Progression Free Survival (PFS)

Time: by month 24

Other Outcomes

Description: Incidence rate of BCR-ABL1 point mutations that are newly found during the course of radotinib treatment

Measure: BCR-ABL1 point mutation

Time: up to month 24

Description: To measure the concentration of radotinib in blood

Measure: correlation between the concentration of radotinib in blood and the response (efficacy and safety)

Time: up to month 24

Description: Toxicities will be evaluated in all subjects treated with radotinib.

Measure: Incidence of Radotinib-Adverse Events

Time: up to month 24

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 T315I

- Medical history of clinically confirmed myocardial infarction - Medical history of unstable angina (within last 12 months) - Other clinically significant cardiac disease 4. Patients with T315I point mutations 5. Patients with central nervous system involvement as cytopathologically confirmed 6. Severe or uncontrolled chronic disease 7. Significant medical history of congenital or acquired bleeding disorders that are not related to leukemia 8. Patients who previously received radiotherapy to at least 25% of the bodies with high portion of bone marrow 9. Patients who received the major surgery within 4 weeks before the initiation of the IP administration or who failed to recover from the surgery that was performed before then. --- T315I ---



HPO Nodes


HPO: