Korean Post-marketing Surveillance for Sprycel®

Bristol-Myers Squibb (BMS)

Status: Completed

Conditions: Leukemia-Lymphoma; Leukemia, Myelomonocytic, Chronic

Study type: Observational

Funder types: Industry

Identifiers

NCT01464047

CA180-370

Details and patient eligibility

About

The purpose of this post-marketing surveillance is to investigate and confirm the type and incidence of newly identified adverse events and any other factors affecting safety and efficacy of Sprycel® so that the regulatory authority can manage the marketing approval properly.

Enrollment: 670 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Newly diagnosed with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase
• Adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including Imatinib
• Adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL) with resistance or intolerance to prior therapy

Exclusion criteria

• According to Warning/Caution in local label

Trial design

670 participants in 1 patient group

Patients with CML or Ph+ ALL