Overview

This trial is active, not recruiting.

Condition cancer
Treatment nelarabine
Sponsor Novartis
Start date January 2008
End date August 2018
Trial size 300 participants
Trial identifier NCT01376115, 112279

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Time perspective prospective
Arm
Subjects with T-cell acute lymphocytic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LBL) prescribed nelarabine during study period
nelarabine

Primary Outcomes

Measure
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 Outcomes

Measure
Outcome (alive or dead) at one year after the start of treatment
time frame: 1 year

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Official title Drug Use Investigation for ARRANON G (Nelarabine) Injection 250mg
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Novartis.