Clinical trial · Observational
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Myelogenous Leukemia, BCR-ABL1 Positive | Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ponatinib | Drug | Ponatinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- CML patients failed to TKIs except Ponatinib
- description
- The study will involve 100 patients with BCR-ABL1-positive CML who failed to prior targeted therapy other than ponatinib. Patients receiving ponatinib 45 mg once daily as a second-line or later therapy will be enrolled.
- interventionNames
- Drug: Ponatinib
Primary outcomes (1)
- measure
- Dynamics of BCR-ABL1 gene expression by qRT-PCR
- timeFrame
- 24 months
- description
- To explore the dynamics of BCR-ABL1 kinetics by Ponatinib
Secondary outcomes (2)
- measure
- Type and frequency of novel genetic variations (mutations, gene expressions, CNV, INDEL, etc.)
- timeFrame
- 24 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients who are willing to and capable of providing informed consent * Adults with BCR-ABL1-positive CML 1. Males and females aged 18 years and above 2. 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 Criteria: * 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
References
Publications (0)
Data not yet available