Observational Study of Nelarabine in Children and Young Adults
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
1 other identifier
observational
28
9 countries
31
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Feb 2009
Longer than P75 for all trials
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 19, 2009
CompletedFirst Posted
Study publicly available on registry
March 20, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedJanuary 14, 2015
January 1, 2015
5.6 years
March 19, 2009
January 12, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Neurological adverse events
Up to one year after treatment
Secondary Outcomes (2)
Other adverse events
Up to one year after treatment
clinical response rate and survival
one year
Study Arms (1)
Nelarabine
nelarabine 650mg/m2 IV daily for 5 days. repeat every 21 days.
Interventions
Nelarabine is a prodrug of 9-β-D-arabinofuranosylguanine (ara-G), a deoxyguanosine analogue.
Eligibility Criteria
Male or Female 21 years or younger with Relapsed or refractory T-lineage Acute Lymphoblastic Leukaemia (T-ALL) or lymphoblastic lymphoma (T-LBL)
You may qualify if:
- ≤ 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (31)
GSK Investigational Site
Aahur N, Denmark
GSK Investigational Site
Aalborg, DK-9100, Denmark
GSK Investigational Site
Koebenhavn Oe, 2100, Denmark
GSK Investigational Site
Odense C, Denmark
GSK Investigational Site
Bordeaux, 33076, France
GSK Investigational Site
Lille, 59037, France
GSK Investigational Site
Nantes, 44093, France
GSK Investigational Site
Paris, 75475, France
GSK Investigational Site
Paris, 75571, France
GSK Investigational Site
Paris, 75935, France
GSK Investigational Site
Vandœuvre-lès-Nancy, 54511, France
GSK Investigational Site
Hamburg, Hamburg, 20246, Germany
GSK Investigational Site
Essen, North Rhine-Westphalia, 45122, Germany
GSK Investigational Site
Beersheba, 84101, Israel
GSK Investigational Site
Haifa, 31096, Israel
GSK Investigational Site
Petah Tikva, Israel
GSK Investigational Site
Ramat Gan, 52621, Israel
GSK Investigational Site
Bologna, Emilia-Romagna, 40137, Italy
GSK Investigational Site
Rotterdam, 3015 GJ, Netherlands
GSK Investigational Site
Bydgoszcz, Poland
GSK Investigational Site
Lublin, 20-093, Poland
GSK Investigational Site
Warsaw, 00-576, Poland
GSK Investigational Site
Warsaw, 02-781, Poland
GSK Investigational Site
Wroclaw, 50-345, Poland
GSK Investigational Site
Krasnodar, 350007, Russia
GSK Investigational Site
Moscow, 117997, Russia
GSK Investigational Site
Moscow, 119049, Russia
GSK Investigational Site
Barcelona, 08035, Spain
GSK Investigational Site
Boadilla Del Monte (Madrid), 28660, Spain
GSK Investigational Site
Madrid, 28009, Spain
GSK Investigational Site
Madrid, 28047, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 19, 2009
First Posted
March 20, 2009
Study Start
February 1, 2009
Primary Completion
September 1, 2014
Study Completion
September 1, 2014
Last Updated
January 14, 2015
Record last verified: 2015-01