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NCT03709017 Clinical Trial

Iclusig PMS in CML or Ph+ALL Patients

Chronic Myeloid Leukemia Clinical Trial

Official title:
Post-Marketing Surveillance of Safety and Effectiveness of Iclusig® Tablets in Korean Patients With CML or Ph+ ALL Under the "Risk Management Plan"

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03709017
Other study ID # 297-402-00002
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date August 7, 2018
Est. completion date June 2023

Study information
Verified date December 2022
Source Korea Otsuka Pharmaceutical Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a Post-Marketing Surveillance (PMS) of Iclusig® Tablets in accordance with Korean regulations on Risk Management Plan (RMP). This PMS is to assess safety and effectiveness data after administrating Ponatinib (of Iclusig® Tablets) per approved indication, usage and dosage.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 50
Est. completion date June 2023
Est. primary completion date November 29, 2022
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria: - Patients who are prescribed Iclusig® per Prescribing information (PI) for the purpose of treatment Exclusion Criteria: - Patients with known or suspected hypersensitivity to ponatinib or to any ingredient of the drug - Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Ponatinib
Iclusig 45mg, 15mg

Locations
Country Name City State
Korea, Republic of Kosin University Gaspel Hospital Busan

Sponsors (1)
Lead Sponsor Collaborator
Korea Otsuka Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary The incidence rate and the number of Adverse Events (AE)/Adverse Drug Reactions (ADR), Serious AE/ADR, Unexpected AE/ADR until 14 days after last administration
Secondary The number of subjects who satisfy CHR at 3 months and 6 months from administration
Secondary The percentage of subjects who satisfy CHR at 3 months and 6 months from administration
Secondary The number of subjects who satisfy MCyR at 3 months and 6 months from administration
Secondary The percentage of subjects who satisfy MCyR at 3 months and 6 months from administration
Secondary The number of subjects who satisfy MMR at 3 months and 6 months from administration
Secondary The percentage of subjects who satisfy MMR at 3 months and 6 months from administration
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