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
Overview
- Phase
- Not Applicable
- Intervention
- nelarabine
- Conditions
- Leukaemia, Lymphoblastic, Acute
- Sponsor
- GlaxoSmithKline
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Neurological adverse events
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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).
Investigators
Eligibility Criteria
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.
Arms & Interventions
Nelarabine
nelarabine 650mg/m2 IV daily for 5 days. repeat every 21 days.
Intervention: nelarabine
Outcomes
Primary Outcomes
Neurological adverse events
Time Frame: Up to one year after treatment
Secondary Outcomes
- Other adverse events(Up to one year after treatment)
- clinical response rate and survival(one year)