Radotinib as 3rd or Later Line Therapy in CP-CML
REVITAL
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
1 other identifier
interventional
73
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2015
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 5, 2015
CompletedFirst Posted
Study publicly available on registry
April 21, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2019
CompletedMay 11, 2016
May 1, 2016
3.9 years
April 5, 2015
May 10, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
by 12 months after radotinib treatment
Secondary Outcomes (2)
Rate of Major Molecular response (MR3.0) on each time point
up to 12 months
The number of Participants with Adverse Events
12 months
Study Arms (1)
Radotinib
EXPERIMENTALRadotinib treatement single arm
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ulsan University Hospital
Ulsan, 682714, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hawk Kim, M.D., Ph.D.
Ulsan University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
April 5, 2015
First Posted
April 21, 2015
Study Start
April 1, 2015
Primary Completion
March 1, 2019
Study Completion
March 1, 2019
Last Updated
May 11, 2016
Record last verified: 2016-05