Iclusig PMS in CML or Ph+ALL Patients
NCT03709017 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 50
Last updated 2022-12-07
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.
Conditions
- Chronic Myeloid Leukemia
- Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia
Interventions
- DRUG
-
Ponatinib
Iclusig 45mg, 15mg
Sponsors & Collaborators
-
Korea Otsuka Pharmaceutical Co., Ltd.
lead INDUSTRY
Eligibility
- Min Age
- 19 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-08-07
- Primary Completion
- 2022-11-29
- Completion
- 2023-06-30
Countries
- South Korea
Study Locations
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