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

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2017 by Novartis ( Novartis Pharmaceuticals )
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01376115
First received: June 16, 2011
Last updated: June 30, 2017
Last verified: June 2017
  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: Other
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 ]

Estimated Enrollment: 300
Actual Study Start Date: January 18, 2008
Estimated Study Completion Date: October 18, 2017
Estimated Primary Completion Date: October 18, 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

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01376115

Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682 Novartis.email@novartis.com
Contact: Novartis Pharmaceuticals

Locations
Japan
University of Tsukuba Hospital Recruiting
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
Study First Received: June 16, 2011
Last Updated: June 30, 2017

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

ClinicalTrials.gov processed this record on July 26, 2017