Status:
COMPLETED
Genomics Study in CML Patients With Ponatinib Treatment
Lead Sponsor:
Dong-Wook Kim
Collaborating Sponsors:
Ulsan National Institute of Science and Technology
Takeda
Conditions:
Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Eligibility:
All Genders
18+ years
Brief Summary
This study will evaluate whether responsiveness and adverse events (AEs) to second-line or later ponatinib treatment are associated with genetic variations as measured by real-time quantitative polyme...
Detailed Description
Ponatinib treatment will be initiated per usual treatment procedure at 45 mg once daily p.o., which will be gradually decreased to 30 mg and 15 mg according to the predefined criteria based on respons...
Eligibility Criteria
Inclusion
- Patients who are willing to and capable of providing informed consent
- Adults with BCR-ABL1-positive CML
- Males and females aged 18 years and above
- Adequate organ function
- Subjects who were resistant or intolerant to prior targeted therapy other than ponatinib and with an indication for ponatinib treatment according to the acceptance criteria by the Ministry of Food and Drug Safety (MFDS)
- Women of childbearing potential (WOCBP) should have a negative serum or urine pregnancy test (with a sensitivity of at least 25 IU/L or equivalent to HCG) within 24 hours before initiating ponatinib treatment
- Female subjects who are not breastfeeding
Exclusion
- Patients who were previously treated with ponatinib
- Patients aged below 18 years of age
- Diagnosis of severe comorbidity at baseline
- Any other cancers within 3 years
Key Trial Info
Start Date :
September 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 25 2024
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT06945146
Start Date
September 1 2020
End Date
September 25 2024
Last Update
April 25 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Seoul St. Mary's Hospital
Seoul, South Korea, 137-701