Iclusig PMS in CML or Ph+ALL Patients

Otsuka

Status: Active, not recruiting

Conditions: Chronic Myeloid Leukemia; Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia

Treatments: Drug: Ponatinib

Study type: Observational

Funder types: Industry

Identifiers

NCT03709017

297-402-00002

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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