Efficacy and Safety of Dose Redution of Radotinib as a First Line Treament in Ph+ CML (NCT06665412) | Clinical Trial Compass
RecruitingNot Applicable
Efficacy and Safety of Dose Redution of Radotinib as a First Line Treament in Ph+ CML
South Korea168 participantsStarted 2024-10-24
Plain-language summary
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.
Who can participate
Age range19 Years
SexALL
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Inclusion criteria
✓. 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)
✓. Patients with positive Philadelphia chromosome and confirmed expression of BCR:ABL1 transcript
✓. ECOG scale 0, 1 or 2
✓. Patients who have adequate organ functions as defined below:
✓. Women of childbearing potential should have a negative serum or urine pregnancy test
✓. Women of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and for a period of at least 1 month (4 weeks) after the last dose of investigational product in such a manner that the risk of pregnancy is minimized.
✓. Patients providing written informed consent form before the study related screening procedures.
Exclusion criteria
✕. 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.
What they're measuring
1
To evaluate MMR rate up to 12months following the treatment of Radotinib