Actively Recruiting
Efficacy and Safety of Dose Redution of Radotinib as a First Line Treament in Ph+ CML
Led by Il-Yang Pharm. Co., Ltd. · Updated on 2024-10-30
168
Participants Needed
2
Research Sites
114 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy and Safety of Dose Redution of Radotinib as a First Line Treament in Ph+ CML
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients aged 19 years old or older
- Confirmed diagnosis of chronic phase chronic myeloid leukemia within the last 8 weeks by chromosome or bone marrow testing
- Chronic phase CML defined by: blast cells in blood and bone marrow less than 15%, sum of blast and promyelocyte cells less than 30%, basophils in blood less than 20%, platelet count at least 50,000/mm3 (transient low platelets from prior therapy accepted), and no cancer spread outside the bone marrow except liver and spleen enlargement
- Positive Philadelphia chromosome and confirmed BCR:ABL1 transcript expression
- ECOG performance status of 0, 1, or 2
- Adequate organ function with normal bilirubin, liver enzymes, creatinine, amylase, lipase, and alkaline phosphatase levels
- Women of childbearing potential must have a negative pregnancy test and use effective contraception during the study and for 1 month after last dose
- Provide written informed consent before screening
You will not qualify if you...
- Philadelphia chromosome negative patients
- Patients who used Radotinib for 8 days or more before study entry
- Patients treated with other targeted anti-cancer therapies except Hydrea or Agrylin
- Hypersensitivity to Radotinib or its ingredients
- Impaired cardiac function including inability to measure QT interval, left bundle branch block, pacemaker, long QT syndrome or family history, QTcF >450 msec, clinically significant bradycardia, recent heart attack or unstable angina, or other serious heart diseases
- CNS involvement confirmed by cytology unless asymptomatic
- Severe or uncontrolled chronic illnesses such as diabetes or infections
- Significant bleeding disorders not related to leukemia
- Prior radiotherapy to 25% or more of bone marrow
- Major surgery within 4 weeks before study or unresolved side effects from surgery
- Other significant cancers diagnosed within 5 years except basal cell carcinoma
- Current use of strong CYP3A4 inhibitors or inducers that cannot be safely stopped
- Current use of medications that may prolong QT interval that cannot be safely stopped
- Gastrointestinal diseases or conditions affecting drug absorption
- History of acute or chronic pancreatitis within 1 year
- Acute or chronic liver, pancreas, or severe kidney disease
- Positive for hepatitis B surface antigen or hepatitis C antibody unless inactive or eligible by investigator
- Positive HIV antibody test
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Hallym University Sacred Heart Hosptial
Anyang-si, Gyeonnggi-do, South Korea, 14068
Actively Recruiting
2
Keimyung University Daegu Dongsan Hospital
Daegu, South Korea, 42601
Not Yet Recruiting
Research Team
N
Na Yun Kim
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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