The purpose of this study is to provide treatment with lyophilized S95014 in pediatric patients with ALL who completed the CL2-95014-002 study during the induction phase and who are clinically benefitting from S95014 without major toxicity.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
75
Each patient was administrated, over 1 to 2 hours, every 2 weeks Lyophilized S95014 intravenously at the dose of 1000, 2000 or 2500U/m2, as per investigator's judgement. In total, 9 infusions of lyophilized S95014 were administrated (at week 7, 9, 11, 15, 17, 19, 23, 25 and 27).Patients received other backbone chemotherapy agents as per ALL-MB 2015.
Regional Children Clinical Hospital
Chelyabinsk, Russia
Children Regional Clinical Hospital
Krasnodar, Russia
Russian Children Clinical Hospital
Moscow, Russia
Regional Children Hospital
Nizhny Novgorod, Russia
Incidence of Adverse Events (AEs) (Safety and Tolerability)
All Adverse events (AEs) including Treatment Emergent Adverse Events (TEAEs) causality and severity based on NCI CTCAE 5.0.
Time frame: Through study completion, approximately 19 months
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V.A. Almazov National Medical Research Center
Saint Petersburg, Russia
Regional Children Clinical Hospital
Yekaterinburg, Russia