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

NCT ID: NCT01376115

Last Updated: 2017-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

343 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-18

Study Completion Date

2017-10-24

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Subjects administered nelarabine

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

Nelarabine

Intervention Type DRUG

Interventions

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Nelarabine

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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University of Tsukuba Hospital

Tsukuba, , Japan

Site Status

Countries

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Japan

Other Identifiers

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112279

Identifier Type: -

Identifier Source: org_study_id