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

• Sponsor: Novartis Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01376115
• Collaborator: (none)
• Enrollment: 343
• Location: 1
• Actual Duration (Months): 117.2
• Patients Per Site Per Month: 2.9

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cancer	Drug: Nelarabine

Study Design

• Study Type: Observational
• Actual Enrollment: 343 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Drug Use Investigation for ARRANON G (Nelarabine) Injection 250mg
• Actual Study Start Date: Jan 18, 2008
• Actual Primary Completion Date: Oct 24, 2017
• Actual Study Completion Date: Oct 24, 2017

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. The number of adverse events in Japanese subjects treated with nelarabine based on prescribing information under the conditions of general clinical practice. [1 year]

2. Any incidence of adverse events related to neurological disorder, hypotension, and blood disorder and their details [1 year]

Secondary Outcome Measures

1. Outcome (alive or dead) at one year after the start of treatment [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	University of Tsukuba Hospital	Tsukuba		Japan

Sponsors and Collaborators

• Novartis Pharmaceuticals

Investigators

• Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novartis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT01376115
• Other Study ID Numbers: 112279
• First Posted: Jun 20, 2011
• Last Update Posted: Nov 1, 2017
• Last Verified: Oct 1, 2017

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

Study Results

No Results Posted as of Nov 1, 2017