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Genomics Study in CML Patients With Ponatinib Treatment

NCT06945146 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 65

Last updated 2025-04-25

No results posted yet for this study

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 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

  • Chronic Myelogenous Leukemia, BCR-ABL1 Positive

Interventions

DRUG

Ponatinib

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 responsiveness to treatment and AEs in the course of the treatment.

Sponsors & Collaborators

  • Ulsan National Institute of Science and Technology

    collaborator UNKNOWN

  • Takeda

    collaborator INDUSTRY

  • Dong-Wook Kim

    lead OTHER

Principal Investigators

  • Dong-Wook Kim, MD, PhD · Eulji University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2024-08-31
Completion
2024-09-25
FDA Drug
Yes

Countries

  • South Korea

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06945146 on ClinicalTrials.gov