Back to resultsRadotinib as 3rd or Later Line Therapy in CP-CML (REVITAL)
Primary Purpose
Chronic Myeloid Leukemia
Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Radotinib
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Myeloid Leukemia focused on measuring Chronic myeloid leukemia, Intolerance, Resitance, Radotinib
Eligibility 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
Sites / Locations
- Ulsan University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Radotinib
Arm Description
Radotinib treatement single arm
Outcomes
Primary Outcome Measures
Rate of Major cytogenetic response
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
The number of Participants with Adverse Events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02422719
Brief Title
Radotinib as 3rd or Later Line Therapy in CP-CML
Acronym
REVITAL
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 Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2015 (undefined)
Primary Completion Date
March 2019 (Anticipated)
Study Completion Date
March 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ulsan University Hospital
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Myeloid Leukemia
Keywords
Chronic myeloid leukemia, Intolerance, Resitance, Radotinib
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
73 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Radotinib
Arm Type
Experimental
Arm Description
Radotinib treatement single arm
Intervention Type
Drug
Intervention Name(s)
Radotinib
Other Intervention Name(s)
Supect
Intervention Description
Radotinib 400mg bid
Primary Outcome Measure Information:
Title
Rate of Major cytogenetic response
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.
Time Frame
by 12 months after radotinib treatment
Secondary Outcome Measure Information:
Title
Rate of Major Molecular response (MR3.0) on each time point
Time Frame
up to 12 months
Title
The number of Participants with Adverse Events
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hae Kyung Shin, R.N.
Phone
+82-52-230-1418
Email
gem9771uuh@naver.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hawk Kim, M.D., Ph.D.
Organizational Affiliation
Ulsan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ulsan University Hospital
City
Ulsan
ZIP/Postal Code
682714
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hawk Kim, M.D., Ph.D.
Phone
+82-52-250-8892
Email
kimhawkmd@gmail.com
First Name & Middle Initial & Last Name & Degree
Hawk Kim, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Jae Cheol Jo, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Yoonsuk Choi, M.D., Ph.D.
12. IPD Sharing Statement
Learn more about this trial
Radotinib as 3rd or Later Line Therapy in CP-CML
We'll reach out to this number within 24 hrs