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

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ClinicalTrials.gov Identifier: NCT01376115
Recruitment Status : Completed
First Posted : June 20, 2011
Last Update Posted : November 1, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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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.

Condition or disease Intervention/treatment
Cancer Drug: Nelarabine

Study Design
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Study Type : Observational
Actual Enrollment : 343 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Drug Use Investigation for ARRANON G (Nelarabine) Injection 250mg
Actual Study Start Date : January 18, 2008
Actual Primary Completion Date : October 24, 2017
Actual Study Completion Date : October 24, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Nelarabine

Groups and Cohorts
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Group/Cohort Intervention/treatment
Subjects administered nelarabine
Subjects with T-cell acute lymphocytic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LBL) prescribed nelarabine during study period
 Drug: Nelarabine


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. Outcome (alive or dead) at one year after the start of treatment [ Time Frame: 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Subjects with the following diseases in Japanese adults and children

  1. T-cell acute lymphocytic leukemia (T-ALL)
  2. T-cell lymphoblastic lymphoma (T-LBL)
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01376115


Locations
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Japan
University of Tsukuba Hospital
Tsukuba, Japan
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01376115     History of Changes
Other Study ID Numbers: 112279
First Posted: June 20, 2011    Key Record Dates
Last Update Posted: November 1, 2017
Last Verified: October 2017

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No