Observational Study of Nelarabine in Children and Young Adults

Completed

• Conditions: Leukaemia, Lymphoblastic, Acute
• Interventions: Drug: nelarabine

• Registration Number: NCT00866671
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-03-19
• Study First Submitted QC: 2009-03-19
• Study First Posted: 2009-03-20
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-12
• Last Update Posted: 2015-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Nelarabine	nelarabine	nelarabine 650mg/m2 IV daily for 5 days. repeat every 21 days.

Primary Outcome Measures

Name	Time	Method
Neurological adverse events	Up to one year after treatment

Secondary Outcome Measures

Name	Time	Method
Other adverse events	Up to one year after treatment
clinical response rate and survival	one year

Trial Locations

Locations (1)

GSK Investigational Site; 🇪🇸 Madrid, Spain