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Acute B-Cell Lymphoblastic Leukaemia clinical trials

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NCT ID: NCT03156790 Recruiting - Clinical trials for Acute B-Cell Lymphoblastic Leukaemia

PK, PD, Safety and Immunogenicity of Spectrila in Adults With Acute B-cell Lymphoblastic Leukaemia

Start date: April 26, 2019
Phase: Phase 2
Study type: Interventional

This is a non-controlled, single-arm, open-label clinical trial to describe the PK, PD, immunogenicity and safety of ASNase. All subjects enrolled will receive the IP recombinant ASNase (Spectrila®). Since Spectrila is already approved in the European Economic Area for first-line treatment of ALL patients of all age groups and showed similar efficacy and safety in comparison to Asparaginase medac no blinding or control groups are necessary. As underlying treatment protocol the BRALL 2014 treatment protocol will be used.