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

Chronic Myeloid Leukemia Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02422719
• Other study ID #: RAD-201501
• Status: Recruiting
• Phase: Phase 2
• First received: April 5, 2015
• Last updated: May 10, 2016
• Start date: April 2015
• Est. completion date: March 2019

Study information

• Verified date: May 2016
• Source: Ulsan University Hospital
• Contact: Hae Kyung Shin, R.N.
• Phone: +82-52-230-1418
• Email: gem9771uuh[@]naver.com
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 73
• Est. completion date: March 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Myeloid Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Leukemia, Myeloid, Chronic-Phase

Intervention

Drug:
• Radotinib
Radotinib 400mg bid

Locations

Country	Name	City	State
Korea, Republic of	Ulsan University Hospital	Ulsan

Sponsors (1)

Lead Sponsor	Collaborator
Ulsan University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Rate of Major Molecular response (MR3.0) on each time point		up to 12 months	No
Secondary	The number of Participants with Adverse Events		12 months	Yes