Iclusig PMS in CML or Ph+ALL Patients
Active, not recruiting
- Conditions
- Chronic Myeloid LeukemiaPhiladelphia Chromosome-positive Acute Lymphoblastic Leukemia
- Registration Number
- NCT03709017
- Lead Sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 50
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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method The number of subjects who satisfy MCyR at 3 months and 6 months from administration The number of subjects who satisfy CHR at 3 months and 6 months from administration The percentage of subjects who satisfy MCyR 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 MMR at 3 months and 6 months from administration The percentage of subjects who satisfy MMR at 3 months and 6 months from administration
Trial Locations
- Locations (1)
Kosin University Gaspel Hospital
🇰🇷Busan, Korea, Republic of
Kosin University Gaspel Hospital🇰🇷Busan, Korea, Republic of