NCT06945146Completed
Genomics Study in CML Patients With Ponatinib Treatment
The Comprehensive Assessment of BCR-ABL1 Gene Expression and Genetic Variations by qRT-PCR and NGS Assays in Chronic Myeloid Leukemia Patients Who Are Treated With Ponatinib (CAP Study)
Source: ClinicalTrials.gov · Last updated 25 Apr 2025
Brief summary (registry, in English)
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 polymerase chain reaction (qRT-PCR) and next-generation sequencing (NGS) in patients with CML of any stage who failed prior multiple targeted therapies except ponatinib.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 65 (actual)
- First submitted
- 18 Apr 2025
- Start date
- 1 Sept 2020
- Primary completion date
- 31 Aug 2024
- Lead sponsor
- Dong-Wook Kim
- Diseases
- Chronic myeloid leukaemia
- NCT number
- NCT06945146
What you commit to
- Study type: Observational
- Participants enrolled: 65
- From 1 Sept 2020 to the primary completion date, 31 Aug 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who were previously treated with ponatinib
Other illness
- Any other cancers within 3 years
Age
- Patients aged below 18 years of age
Other
- Diagnosis of severe comorbidity at baseline
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Seoul St. Mary's Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.