Overview

Administration of Allogenic Red Blood Cells Loaded L-asparaginase in Cases of Relapse of Acute Lymphoblastic Leukaemia

Status:
Completed
Trial end date:
2009-03-01
Target enrollment:
Participant gender:
Summary
Primary objective : - To explore the relation between 3 doses of GRASPA and duration of asparagine depletion (< 2µmol/l) Secondary objective : - Pharmacokinetic / Pharmacodynamic parameters - toxicity - Study duration : 2 years - Study treatment : Red blood cells loaded with L asparaginase versus native L asparaginase - Associated treatments : COPRALL chemotherapy - Randomization : centralised randomisation on scratching list
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
ERYtech Pharma
Collaborator:
Centre Leon Berard
Treatments:
Asparaginase