Genomics Study in CML Patients With Ponatinib Treatment

Plain-language summary

This study examines genomic features in patients with chronic myeloid leukemia (CML) receiving Ponatinib treatment. It enrolled BCR-ABL1-positive adults aged 18 and older who were resistant to or intolerant of prior targeted therapies. This non-phase study was conducted and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Completed

Sponsor

Dong-Wook Kim

Intervention

Ponatinib

Start date

9/1/2020

Estimated completion

9/25/2024

Countries

South Korea

Related genes

Locations

• Seoul, South Korea

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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