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OpenTrials
Completed

NCT Number: NCT01376115

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

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.

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Key information

Conditions

Cancer Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Tsukuba Hospital

Tsukuba, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

nelarabine

Drug

Primary outcomes

  1. The number of adverse events in Japanese subjects treated with nelarabine based on prescribing information under the conditions of general clinical practice.

    Time frame: 1 year

  2. Any incidence of adverse events related to neurological disorder, hypotension, and blood disorder and their details

    Time frame: 1 year

Secondary outcomes

  1. Outcome (alive or dead) at one year after the start of treatment

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Important dates

Study start
2008
Primary completion
2017
Study completion
2017
First posted
Jun 20, 2011
Registry last updated
Nov 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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