REVITAL: Radotinib as 3rd or Later Line Therapy in CP-CML

Sponsor

Ulsan University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02422719

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Myeloid Leukemia	Drug: Radotinib	Phase 2

Detailed Description

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. The primary end point is major cytogenetic response by 12 months.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

73 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2015

Anticipated Primary Completion Date :

Mar 1, 2019

Anticipated Study Completion Date :

Mar 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Radotinib Radotinib treatement single arm	Drug: Radotinib Radotinib 400mg bid Other Names: Supect

Arm

Intervention/Treatment

Experimental: Radotinib

Radotinib treatement single arm

Drug: Radotinib

Radotinib 400mg bid

Other Names:

Supect

Outcome Measures

Primary Outcome Measures

Rate of Major cytogenetic response [by 12 months after radotinib treatment]
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.

Secondary Outcome Measures

Rate of Major Molecular response (MR3.0) on each time point [up to 12 months]
The number of Participants with Adverse Events [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).
ECOG 0, 1, 2
Patients who are agree and signed to informed consent.

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