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
• Status: Active, not recruiting
• 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
• 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

Related Conditions & MeSH terms

• Chronic Myeloid Leukemia
• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Philadelphia Chromosome
• Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

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