Status:
COMPLETED
Observational Study of Nelarabine in Children and Young Adults
Lead Sponsor:
GlaxoSmithKline
Conditions:
Leukaemia, Lymphoblastic, Acute
Eligibility:
All Genders
Up to 21 years
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 leu...
Eligibility Criteria
Inclusion
- ≤ 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
- 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.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00866671
Start Date
February 1 2009
End Date
September 1 2014
Last Update
January 14 2015
Active Locations (31)
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1
GSK Investigational Site
Aahur N, Denmark
2
GSK Investigational Site
Aalborg, Denmark, DK-9100
3
GSK Investigational Site
Koebenhavn Oe, Denmark, 2100
4
GSK Investigational Site
Odense C, Denmark