Clinical trial
A multicentre, open, randomized, Phase II/III study, evaluating efficacy and safety of erythrocytes encapsulating L-Asparaginase (GRASPA�) versus reference L-asparaginase treatment in combination with standard polychemotherapy in patients with first recur
Determine the efficacy and safety of GRASPA� at a dose equivalent to 150 IU/kg of L-asparaginase combined with standard polychemotherapy in several populations of patients with first recurrence of ALL Ph-, i.e. children from 1 to 17 years old, adults from 18 to 55 years old, with or without known hypersensitivity to L-asparaginase.
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Study start date | 2013-01-31 |