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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01376115
First Posted: June 20, 2011
Last Update Posted: November 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  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: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Drug Use Investigation for ARRANON G (Nelarabine) Injection 250mg

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

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 ]
  • Any incidence of adverse events related to neurological disorder, hypotension, and blood disorder and their details [ Time Frame: 1 year ]

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

Enrollment: 343
Actual Study Start Date: January 18, 2008
Study Completion Date: October 24, 2017
Primary Completion Date: October 24, 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
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
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
Japan
University of Tsukuba Hospital
Tsukuba, Japan
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01376115     History of Changes
Other Study ID Numbers: 112279
First Submitted: June 16, 2011
First Posted: June 20, 2011
Last Update Posted: November 1, 2017
Last Verified: October 2017

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