NCT03709017

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 7, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 11, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 17, 2018

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 29, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

December 7, 2022

Status Verified

December 1, 2022

Enrollment Period

4.3 years

First QC Date

October 11, 2018

Last Update Submit

December 6, 2022

Conditions

Chronic Myeloid LeukemiaPhiladelphia Chromosome-positive Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • The number of subjects who satisfy CHR

    at 3 months and 6 months from administration

  • The percentage of subjects who satisfy CHR

    at 3 months and 6 months from administration

  • The number of subjects who satisfy MCyR

    at 3 months and 6 months from administration

  • The percentage of subjects who satisfy MCyR

    at 3 months and 6 months from administration

  • The number of subjects who satisfy MMR

    at 3 months and 6 months from administration

  • +1 more secondary outcomes

Interventions

PonatinibDRUG

Iclusig 45mg, 15mg

Also known as: Iclusig

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Patients who are prescribed Iclusig® per Prescribing information (PI) for the purpose of treatment

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kosin University Gaspel Hospital

Busan, South Korea

Location

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

ponatinib

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsMyeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2018

First Posted

October 17, 2018

Study Start

August 7, 2018

Primary Completion

November 29, 2022

Study Completion

June 1, 2023

Last Updated

December 7, 2022

Record last verified: 2022-12

Locations

KR(1)