Efficacy and Safety of Dose Redution of Radotinib as a First Line Treament in Ph+ CML
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorIl-Yang Pharm. Co., Ltd.
About this trial
The goal of this observational study is to learn about the efficacy and safety profile when Radotinib dose redution is performed in Ph+ CML subjects.
The main efficacy is checked by MMR rate by 12 months from IP treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female patients aged 19 years old or older
Patients with confirmed diagnosis of chronic phase CML within last 8weeks(throung chromosome testing or bone marrow testing)
Blast in peripheral blood and bone marrow <15%
The sum of blast and promyelocyte in peripheral blood and bone marrow <30%
Disqualifiers
Patients with Philadelphia chromosome negative
Patients who used Radotinib for 8 days or longer before study entry
Patients who had been treated with other targeted anti-cancer therapy, except for Hydrea or Agrylin, which inhibits the growth of leukemic cells
Patients who have hypersensitivity to active ingredient or any of the excipients of this investigational product.
Trial population
Newly diagnosed, CP-CML patients
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Radotinib Hydrochloride
Drug200mg BID, every day up to 12months
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
To evaluate MMR rate up to 12months following the treatment of Radotinib
Time frame
up to 12monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov