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Status unknownNCT03709017Updated Dec 7, 2022

Iclusig PMS in CML or Ph+ALL Patients

An observational study in Chronic Myeloid Leukemia and Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia, sponsored by Korea Otsuka Pharmaceutical Co., Ltd.. Status unknown at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2022-12-07.

Sponsored by Korea Otsuka Pharmaceutical Co., Ltd. · Observational

The sponsor has not verified this record recently (last verified Dec 2022), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
50
Ages
19 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Myeloid Leukemia
  • Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia
03

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Inclusion criteria

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

Exclusion criteria

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
04

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No

Interventions

  • DrugPonatinib

    Iclusig 45mg, 15mg

    Also known as: Iclusig

05

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. The number of subjects who satisfy CHR

    Time frame: at 3 months and 6 months from administration

  2. The percentage of subjects who satisfy CHR

    Time frame: at 3 months and 6 months from administration

  3. The number of subjects who satisfy MCyR

    Time frame: at 3 months and 6 months from administration

  4. The percentage of subjects who satisfy MCyR

    Time frame: at 3 months and 6 months from administration

  5. The number of subjects who satisfy MMR

    Time frame: at 3 months and 6 months from administration

  6. The percentage of subjects who satisfy MMR

    Time frame: at 3 months and 6 months from administration

06

Study locations

1 site
  • Kosin University Gaspel Hospital
    Busan, Korea, Republic of
07

Registry details

Key details

Study ID
NCT03709017
Lead sponsor
Korea Otsuka Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Oct 17, 2018
Start date
Aug 7, 2018
Primary completion
Nov 29, 2022
Completion
Jun 2023 (estimated)
Last update
Dec 7, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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