NCT01376115

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. 1.T-cell acute lymphocytic leukemia (T-ALL)
  2. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
343

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 18, 2008

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

June 16, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 20, 2011

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 24, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 24, 2017

Completed
Last Updated

November 1, 2017

Status Verified

October 1, 2017

Enrollment Period

9.8 years

First QC Date

June 16, 2011

Last Update Submit

October 30, 2017

Conditions

Cancer

Outcome Measures

Primary Outcomes (2)

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

    1 year

  • Any incidence of adverse events related to neurological disorder, hypotension, and blood disorder and their details

    1 year

Secondary Outcomes (1)

  • Outcome (alive or dead) at one year after the start of treatment

    1 year

Study Arms (1)

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

Interventions

NelarabineDRUG
Subjects administered nelarabine

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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)

You may qualify if:

  • Diagnosis of T-cell acute lymphocytic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LBL)

You may not qualify if:

  • Subjects with hypersensitivity to nelarabine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Tsukuba Hospital

Tsukuba, Japan

Location

MeSH Terms

Conditions

Neoplasms

Interventions

nelarabine

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2011

First Posted

June 20, 2011

Study Start

January 18, 2008

Primary Completion

October 24, 2017

Study Completion

October 24, 2017

Last Updated

November 1, 2017

Record last verified: 2017-10

Locations

JP(1)