Cancer
Conditions
Brief 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.
Interventions
DRUGNelarabine
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of adverse events in Japanese subjects treated with nelarabine based on prescribing information under the conditions of general clinical practice. | 1 year |
| Any incidence of adverse events related to neurological disorder, hypotension, and blood disorder and their details | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Outcome (alive or dead) at one year after the start of treatment | 1 year |
Countries
Japan
Outcome results
None listed