Spots Global Cancer Trial Database for Observational Study of Nelarabine in Children and Young Adults
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Trial Identification
Brief Title: Observational Study of Nelarabine in Children and Young Adults
Official Title: 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 ID: NCT00866671
Conditions
Interventions
Study Description
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:
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
GSK Investigational Site, Aahur N, , Denmark
GSK Investigational Site, Aalborg, , Denmark
GSK Investigational Site, Koebenhavn Oe, , Denmark
GSK Investigational Site, Odense C, , Denmark
GSK Investigational Site, Bordeaux cedex, , France
GSK Investigational Site, Lille Cedex, , France
GSK Investigational Site, Nantes Cedex 1, , France
GSK Investigational Site, Paris Cedex 10, , France
GSK Investigational Site, Paris cedex 12, , France
GSK Investigational Site, Paris Cedex 19, , France
GSK Investigational Site, Vandoeuvre-Les-Nancy, , France
GSK Investigational Site, Essen, Nordrhein-Westfalen, Germany
GSK Investigational Site, Hamburg, , Germany
GSK Investigational Site, Beer-Sheva, , Israel
GSK Investigational Site, Haifa, , Israel
GSK Investigational Site, Petach-Tikva, , Israel
GSK Investigational Site, Ramat Gan, , Israel
GSK Investigational Site, Bologna, Emilia-Romagna, Italy
GSK Investigational Site, Rotterdam, , Netherlands
GSK Investigational Site, Bydgoszcz, , Poland
GSK Investigational Site, Lublin, , Poland
GSK Investigational Site, Warszawa, , Poland
GSK Investigational Site, Warszawa, , Poland
GSK Investigational Site, Wroclaw, , Poland
GSK Investigational Site, Krasnodar, , Russian Federation
GSK Investigational Site, Moscow, , Russian Federation
GSK Investigational Site, Moscow, , Russian Federation
GSK Investigational Site, Barcelona, , Spain
GSK Investigational Site, Boadilla del Monte (Madrid), , Spain
GSK Investigational Site, Madrid, , Spain
GSK Investigational Site, Madrid, , Spain
Contact Details
Name: GSK Clinical Trials
Affiliation: GlaxoSmithKline
Role: STUDY_DIRECTOR
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