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Report for Clinical Trial NCT02422719

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Radotinib Efficacy and Safety Validation in Chronic Phase Chronic Myeloid Leukemia Patients Who Are Intolerant or Resistant to at Least Two Tyrosine Kinase Inhibitors As a Third or Subsequent Line Therapy

The purpose of this study is to determine whether radotinib is effective and safe for patients with chronic myeloid leukemia, chronic phase who are intolerable or resistant to prior 2 or more tyrosine kinase inhibitors.

NCT02422719 Chronic Myeloid Leukemia
MeSH:Leukemia Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive
HPO:Chronic myelogenous leukemia Leukemia Myeloid leukemia

1 Interventions

Name: Radotinib

Description: Radotinib 400mg bid
Type: Drug
Group Labels: 1

Radotinib


Primary Outcomes

Description: The rate of achieving major cytogenetic response [35% or less t(9;22) chromosome by conventional banding technique] in bone marrow by 12 months after radotinib treatment will be the primary end point.

Measure: Rate of Major cytogenetic response

Time: by 12 months after radotinib treatment

Secondary Outcomes

Measure: Rate of Major Molecular response (MR3.0) on each time point

Time: up to 12 months

Measure: The number of Participants with Adverse Events

Time: 12 months

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 T315I

Exclusion Criteria: - T315I mutation - Prior exposure to radotinib - Accelerated or blastic phase - galactose intolerance, severe lactase deficiency or glucose galactose malabsorption - Prior history of intensive cytotoxic chemotherapy except for TKIs - Significant cardiac problem - QTcF > 450 msec - Pancreatitis history prior to study enrollment - Clinically significant malignant disease other than CML - Pregnant or breast feeding woman Inclusion Criteria: - Chronic myeloid leukemia chronic phase (CP-CML) patients who are not tolerable or resistant to prior 2 or more tyrosine kinase inhibitors (TKIs). --- T315I ---

Exclusion Criteria: - T315I mutation - Prior exposure to radotinib - Accelerated or blastic phase - galactose intolerance, severe lactase deficiency or glucose galactose malabsorption - Prior history of intensive cytotoxic chemotherapy except for TKIs - Significant cardiac problem - QTcF > 450 msec - Pancreatitis history prior to study enrollment - Clinically significant malignant disease other than CML - Pregnant or breast feeding woman Chronic Myeloid Leukemia Leukemia Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive The purpose of this study is to determine whether radotinib 400mg bid is effective and safe for patients with chronic myeloid leukemia, chronic phase who are intolerable or resistant to prior 2 or more tyrosine kinase inhibitors. --- T315I ---



HPO Nodes


HPO: