Drug Use Investigation for ARRANON G (Nelarabine) Injection 250mg
- Registration Number
- NCT01376115
- Lead Sponsor
- Novartis Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 343
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Subjects administered nelarabine Nelarabine Subjects with T-cell acute lymphocytic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LBL) prescribed nelarabine during study period
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Outcome (alive or dead) at one year after the start of treatment 1 year
Trial Locations
- Locations (1)
University of Tsukuba Hospital
🇯🇵Tsukuba, Japan