Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02422719
Recruitment Status : Unknown
Verified May 2016 by Hawk Kim, Ulsan University Hospital.
Recruitment status was:  Recruiting
First Posted : April 21, 2015
Last Update Posted : May 11, 2016
Sponsor:
Information provided by (Responsible Party):
Hawk Kim, Ulsan University Hospital

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 73 participants
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 : April 2015
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019


Arm Intervention/treatment
Experimental: Radotinib
Radotinib treatement single arm
Drug: Radotinib
Radotinib 400mg bid
Other Name: Supect




Primary Outcome Measures :
  1. 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.


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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02422719


Contacts
Layout table for location contacts
Contact: Hae Kyung Shin, R.N. +82-52-230-1418 gem9771uuh@naver.com

Locations
Layout table for location information
Korea, Republic of
Ulsan University Hospital Recruiting
Ulsan, Korea, Republic of, 682714
Contact: Hawk Kim, M.D., Ph.D.    +82-52-250-8892    kimhawkmd@gmail.com   
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.         
Sponsors and Collaborators
Ulsan University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Hawk Kim, M.D., Ph.D. Ulsan University Hospital

Layout table for additonal information
Responsible Party: Hawk Kim, Associate Professor, Ulsan University Hospital
ClinicalTrials.gov Identifier: NCT02422719     History of Changes
Other Study ID Numbers: RAD-201501
First Posted: April 21, 2015    Key Record Dates
Last Update Posted: May 11, 2016
Last Verified: May 2016
Keywords provided by Hawk Kim, Ulsan University Hospital:
Chronic myeloid leukemia
Intolerance
Resitance
Radotinib
Additional relevant MeSH terms:
Layout table for MeSH terms
Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases