Observational Study of Nelarabine in Children and Young Adults

Overview

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).

Full Title of Study: “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”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: September 2014

Interventions

  • Drug: nelarabine
    • Nelarabine is a prodrug of 9-β-D-arabinofuranosylguanine (ara-G), a deoxyguanosine analogue.

Arms, Groups and Cohorts

  • Nelarabine
    • nelarabine 650mg/m2 IV daily for 5 days. repeat every 21 days.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 21 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • GlaxoSmithKline
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • GSK Clinical Trials, Study Director, GlaxoSmithKline

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