Drug Use Investigation for ARRANON G (Nelarabine) Injection 250mg

• Status: Completed
• Trial end date: 2017-10-24
• Target enrollment: 0
• Participant gender: All

Summary

To investigate safety and efficacy on Japanese subjects treated with nelarabine injection for intravenous use in clinical settings of the following diseases:

1. T-cell acute lymphocytic leukemia (T-ALL)

2. T-cell lymphoblastic lymphoma (T-LBL) Also, "any adverse events involving neurological disorder, hypotension, and blood disorder and their details" are to be investigated as an item of particular concern. In addition, subject outcome (alive or dead) at one year after the start of treatment will also be investigated.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis; Novartis Pharmaceuticals

Criteria

Inclusion Criteria:

• Diagnosis of T-cell acute lymphocytic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LBL)

Exclusion Criteria:

• Subjects with hypersensitivity to nelarabine