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

Novartis

Status: Completed

Conditions: Cancer

Treatments: Drug: Nelarabine

Study type: Observational

Funder types: Industry

Identifiers

NCT01376115

112279

Details and patient eligibility

About

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.

Enrollment: 343 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

343 participants in 1 patient group

Subjects administered nelarabine

Description:

Subjects with T-cell acute lymphocytic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LBL) prescribed nelarabine during study period

Treatment:

Drug: Nelarabine