Iclusig PMS in CML or Ph+ALL Patients

December 6, 2022 updated by: Korea Otsuka Pharmaceutical Co., Ltd.

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who are prescribed Iclusig® tablets and provide written informed consent will be enrolled. The number of patients to be enrolled by each investigator will vary.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The incidence rate and the number of Adverse Events (AE)/Adverse Drug Reactions (ADR), Serious AE/ADR, Unexpected AE/ADR
Time Frame: until 14 days after last administration
until 14 days after last administration

Secondary Outcome Measures

Outcome Measure
Time Frame
The number of subjects who satisfy CHR
Time Frame: at 3 months and 6 months from administration
at 3 months and 6 months from administration
The percentage of subjects who satisfy CHR
Time Frame: at 3 months and 6 months from administration
at 3 months and 6 months from administration
The number of subjects who satisfy MCyR
Time Frame: at 3 months and 6 months from administration
at 3 months and 6 months from administration
The percentage of subjects who satisfy MCyR
Time Frame: at 3 months and 6 months from administration
at 3 months and 6 months from administration
The number of subjects who satisfy MMR
Time Frame: at 3 months and 6 months from administration
at 3 months and 6 months from administration
The percentage of subjects who satisfy MMR
Time Frame: at 3 months and 6 months from administration
at 3 months and 6 months from administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Korea Otsuka Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 7, 2018

Primary Completion (Actual)

November 29, 2022

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

October 11, 2018

First Submitted That Met QC Criteria

October 15, 2018

First Posted (Actual)

October 17, 2018

Study Record Updates

Last Update Posted (Estimate)

December 7, 2022

Last Update Submitted That Met QC Criteria

December 6, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 297-402-00002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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