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NCT01376115 Clinical Trial

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

Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01376115
Other study ID # 112279
Secondary ID
Status Completed
Phase N/A
First received June 16, 2011
Last updated October 30, 2017
Start date January 18, 2008
Est. completion date October 24, 2017

Study information
Verified date October 2017
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 343
Est. completion date October 24, 2017
Est. primary completion date October 24, 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Nelarabine

Locations
Country Name City State
Japan University of Tsukuba Hospital Tsukuba

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary The number of adverse events in Japanese subjects treated with nelarabine based on prescribing information under the conditions of general clinical practice. 1 year
Primary Any incidence of adverse events related to neurological disorder, hypotension, and blood disorder and their details 1 year
Secondary Outcome (alive or dead) at one year after the start of treatment 1 year
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