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

NCT01376115 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 343

Last updated 2017-11-01

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Nelarabine

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-18
Primary Completion
2017-10-24
Completion
2017-10-24
FDA Drug
Yes

Countries

  • Japan

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01376115 on ClinicalTrials.gov