Observational Study of Nelarabine in Children and Young Adults
Status:
Completed
Trial end date:
2014-09-01
Target enrollment:
Participant gender:
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).