An observational study in Leukaemia, Lymphoblastic, Acute, sponsored by GlaxoSmithKline. Completed at 31 sites in 9 countries. Open to participants aged Up to 21 Years. Per ClinicalTrials.gov, last updated 2015-01-14.
Sponsored by GlaxoSmithKline · Observational
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).
5,441 studies on the registry are indexed under Leukemia; 637 are open to participants now.
This study's enrollment of 28 is below the median of 120 across 744 observational studies indexed under Leukemia.
Browse Leukemia studies →GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Male or Female 21 years or younger with Relapsed or refractory T-lineage Acute Lymphoblastic Leukaemia (T-ALL) or lymphoblastic lymphoma (T-LBL)
Exclusion Criteria:
nelarabine 650mg/m2 IV daily for 5 days. repeat every 21 days.
Drug: nelarabine
Nelarabine is a prodrug of 9-β-D-arabinofuranosylguanine (ara-G), a deoxyguanosine analogue.
Neurological adverse events
Time frame: Up to one year after treatment
Other adverse events
Time frame: Up to one year after treatment
clinical response rate and survival
Time frame: one year
This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.
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GlaxoSmithKline