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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01376115
First received: June 16, 2011
Last updated: NA
Last verified: June 2011
History: No changes posted
  Purpose

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 Intervention
Cancer
 Drug: Nelarabine

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Drug Use Investigation for ARRANON G (Nelarabine) Injection 250mg

Resource links provided by NLM:

Drug Information available for: Nelarabine
U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • Any incidence of adverse events related to neurological disorder, hypotension, and blood disorder and their details [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Outcome (alive or dead) at one year after the start of treatment [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: January 2008
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01376115

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01376115     History of Changes
Other Study ID Numbers: 112279
Study First Received: June 16, 2011
Last Updated: June 16, 2011
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

ClinicalTrials.gov processed this record on May 16, 2013