Aarhus University Hospital is about to start an ALLTogether study of Pharmacokinetics and Immunogenicity of the First Doses of PEG-Asparaginase.
The company Aarhus University Hospital is commencing recruitment for the clinical trial of the Pharmacokinetics and Immunogenicity of the First Doses of PEG-Asparaginase -An ALLTogether Pilot Study.
The condition is Acute Lymphoblastic Leukemia.
A new clinical trial is recruiting patients in the following locations: Denmark.
The trial officially began on the July 1, 2020 and is planned to complete on April 1, 2023.
Acute lymphoblastic leukemia (ALL) is the most common malignant disease in childhood. Survival rates exceed 90% in children and 75% in adults (aged 18-45 years). During the induction period Asparaginase is an indispensable part of the multiagent treatment, but is often associated with hypersensitivity, either with clinical allergy or silent inactivation. In both cases, Asparaginase is inactivated. It is well known that truncation of Asparaginase treatment due to inactivation reduces survival. To approach understanding Asparaginase dynamics and hypersensitivity in ALL patients it is important to examine the pharmacokinetics of Asparaginase. The aim of this study is to identify serological parameters for prediction of hypersensitivity reaction after the first doses of PEG-Asparaginase given intravenously on the ALLTogether protocol.
The population that can be enrolled into this study includes:
- Treated for acute lymphoblastic leukemia (ALL) on the ALL2GETHER pilot protocol.
The link to the complete study profile: https://ichgcp.net/clinical-trials-registry/NCT04843150.
