Last updated: 11/03/2018 12:46:26
This product has been transferred to Novartis. GSK Clinical Study Register is no longer maintained for this study. The most up to date information is available on clinicaltrials.gov.
Drug Use Investigation for ARRANON G (nelarabine) Injection 250mg
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
No longer a GSK study
No longer a GSK study
Trial overview
Official title: Drug Use Investigation for ARRANON G (nelarabine) Injection 250mg
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
The number of adverse events in Japanese subjects treated with nelarabine based on prescribing information under the conditions of general clinical practice.
Timeframe: 1 year
Any incidence of adverse events related to neurological disorder, hypotension, and blood disorder and their details
Timeframe: 1 year
Secondary outcomes:
Outcome (alive or dead) at one year after the start of treatment
Timeframe: 1 year
Interventions:
Enrollment:
300
Primary completion date:
Not applicable
Observational study model:
Other
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Cancer, Neoplasms
Product
nelarabine
Collaborators
Not applicable
Study date(s)
January 2008 to August 2017
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable
Accepts healthy volunteers
none
- Diagnosis of T-cell acute lymphocytic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LBL)
- Subjects with hypersensitivity to nelarabine
Inclusion and exclusion 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
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
No longer a GSK study
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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