Observational Study of Nelarabine in Children and Young Adults

January 12, 2015 updated by: GlaxoSmithKline

A Multicentre, Single Arm, Observational Phase IV Study to Assess the Safety and Efficacy of Nelarabine in Children and Young Adults (up to 21 Years of Age) With Relapsed or Refractory T-Lineage Acute Lymphoblastic Leukaemia or Lymphoblastic Lymphoma

This international, multicentre, single arm, phase IV study will assess the safety and efficacy of nelarabine in children and young adults with relapsed or refractory T-lineage acute lymphoblastic leukaemia (T-ALL) or lymphoblastic lymphoma (T-LBL) whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens. It is a post-authorisation safety study (PASS) conducted for the purpose of confirming the safety profile and the clinical benefit of nelarabine under licensed conditions of use. The study is observational, non-interventional, and will include approximately 40 children and young adults (up to 21 years of age).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

28

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aahur N, Denmark
        • GSK Investigational Site
      • Aalborg, Denmark, DK-9100
        • GSK Investigational Site
      • Koebenhavn Oe, Denmark, 2100
        • GSK Investigational Site
      • Odense C, Denmark
        • GSK Investigational Site
  • France
      • Bordeaux cedex, France, 33076
        • GSK Investigational Site
      • Lille Cedex, France, 59037
        • GSK Investigational Site
      • Nantes Cedex 1, France, 44093
        • GSK Investigational Site
      • Paris Cedex 10, France, 75475
        • GSK Investigational Site
      • Paris Cedex 19, France, 75935
        • GSK Investigational Site
      • Paris cedex 12, France, 75571
        • GSK Investigational Site
      • Vandoeuvre-Les-Nancy, France, 54511
        • GSK Investigational Site
  • Germany
      • Hamburg, Germany, 20246
        • GSK Investigational Site
    • Nordrhein-Westfalen
      • Essen, Nordrhein-Westfalen, Germany, 45122
        • GSK Investigational Site
  • Israel
      • Beer-Sheva, Israel, 84101
        • GSK Investigational Site
      • Haifa, Israel, 31096
        • GSK Investigational Site
      • Petach-Tikva, Israel
        • GSK Investigational Site
      • Ramat Gan, Israel, 52621
        • GSK Investigational Site
  • Italy
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italy, 40137
        • GSK Investigational Site
  • Netherlands
      • Rotterdam, Netherlands, 3015 GJ
        • GSK Investigational Site
  • Poland
      • Bydgoszcz, Poland
        • GSK Investigational Site
      • Lublin, Poland, 20-093
        • GSK Investigational Site
      • Warszawa, Poland, 00-576
        • GSK Investigational Site
      • Warszawa, Poland, 02-781
        • GSK Investigational Site
      • Wroclaw, Poland, 50-345
        • GSK Investigational Site
  • Russian Federation
      • Krasnodar, Russian Federation, 350007
        • GSK Investigational Site
      • Moscow, Russian Federation, 119049
        • GSK Investigational Site
      • Moscow, Russian Federation, 117997
        • GSK Investigational Site
  • Spain
      • Barcelona, Spain, 08035
        • GSK Investigational Site
      • Boadilla del Monte (Madrid), Spain, 28660
        • GSK Investigational Site
      • Madrid, Spain, 28009
        • GSK Investigational Site
      • Madrid, Spain, 28047
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Male or Female 21 years or younger with Relapsed or refractory T-lineage Acute Lymphoblastic Leukaemia (T-ALL) or lymphoblastic lymphoma (T-LBL)

Description

Inclusion Criteria:

  • ≤ 21 years of age
  • Relapsed or refractory T-lineage acute lymphoblastic leukaemia (T-ALL) or lymphoblastic lymphoma (T-LBL)
  • Prior treatment with at least two chemotherapy regimens
  • Selected for treatment with nelarabine

Exclusion Criteria:

  • Known hypersensitivity to the active substance.
  • Women of childbearing potential who are unable or unwilling to use adequate contraceptive measures
  • Males with partners of child bearing potential who are not willing to use condoms or abstinence
  • Patients with persistent neurological toxicity (CTC grade > = grade 2)
  • Adolescents (aged 16 years and over) and adults for whom the physician prescribes the 1500mg/m2 dose of nelarabine.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Nelarabine
nelarabine 650mg/m2 IV daily for 5 days. repeat every 21 days.
Drug: nelarabine
Nelarabine is a prodrug of 9-β-D-arabinofuranosylguanine (ara-G), a deoxyguanosine analogue.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Neurological adverse events
Time Frame: Up to one year after treatment
Up to one year after treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Other adverse events
Time Frame: Up to one year after treatment
Up to one year after treatment
clinical response rate and survival
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

March 19, 2009

First Submitted That Met QC Criteria

March 19, 2009

First Posted (Estimate)

March 20, 2009

Study Record Updates

Last Update Posted (Estimate)

January 14, 2015

Last Update Submitted That Met QC Criteria

January 12, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 111081

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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