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

May 10, 2016 updated by: Hawk Kim, Ulsan University Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

73

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Ulsan, Korea, Republic of, 682714
        • Recruiting
        • Ulsan University Hospital
        • Contact:
        • Principal Investigator:
          • Hawk Kim, M.D., Ph.D.
        • Sub-Investigator:
          • Jae Cheol Jo, M.D., Ph.D.
        • Sub-Investigator:
          • Yoonsuk Choi, M.D., Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Major cytogenetic response
Time Frame: 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.
by 12 months after radotinib treatment

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ulsan University Hospital

Investigators

  • Principal Investigator: Hawk Kim, M.D., Ph.D., Ulsan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Anticipated)

March 1, 2019

Study Completion (Anticipated)

March 1, 2019

Study Registration Dates

First Submitted

April 5, 2015

First Submitted That Met QC Criteria

April 20, 2015

First Posted (Estimate)

April 21, 2015

Study Record Updates

Last Update Posted (Estimate)

May 11, 2016

Last Update Submitted That Met QC Criteria

May 10, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RAD-201501

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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