Initiation of an international collaborative ring Trial for the measurement of asparaginase activity during ALL treatment

Basic data for this project

Description

Almost all clinical trial groups currently address scientific hypotheses regarding the Asparaginase therapy. Dose intensity, scheduling, silent or allergic inactivaton - many aspects need to be elucidated. In addition, individual therapeutic decisions like the switch form an E.coli-prparation to Erwinase or from a non-pegylated to a pegylated preparation need objective analyses of the individual activity pattern. Drug Monitoring (TDM) therefore has been established in various labs all over Europe. Different labs however use different analytical assays. The assays utilize AHA or Asparaginase as substrate and some quantify the assay directly by the analysis of the product of the enzymatic reaction same alternatively again follows different rules. (NH3-Release, utilize additional enzymatic reactions, others). The AHA-assay as lab based routine method in Münster is validated against traded proteins. The MAAT-assay as marketed standard assay is calibrated against E.coli asparaginase. Other assays directly quantify the NH3-release by Nessler´s reaction. Due to this diversity in analytical solutions, a unique interpretation of the different trial results and individual observations becomes more and more challenging. The project therefore intends to set up and run an independent external cross validation process of the different labs and various analytical prcedures.