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

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02422719

Acronym

REVITAL

Enrollment

Registered

2015-04-21

Start date

2015-04-30

Completion date

2019-03-31

Last updated

2016-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Myeloid Leukemia

Keywords

Chronic myeloid leukemia, Intolerance, Resitance, Radotinib

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.

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.

Interventions

DRUGRadotinib

Radotinib 400mg bid

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

South Korea

Contacts

Primary ContactHae Kyung Shin, R.N.

gem9771uuh@naver.com+82-52-230-1418

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026