Study of CM4620 to Reduce the Severity of Pancreatitis Due to Asparaginase
Status:
Recruiting
Trial end date:
2023-12-01
Target enrollment:
Participant gender:
Summary
This is a phase I/II clinical trial assessing the tolerability and efficacy of CM4620 in
children and young adults with acute pancreatitis caused by asparaginase. The tolerability of
CM4620 when given to patients receiving frontline chemotherapy will be determined. The
effectiveness in reducing the severity of pancreatitis will be estimated.
Primary Objectives
To assess the safety of CM4620 administration in children and young adults with asparaginase
associated pancreatitis (AAP).
To profile dose-limiting toxicities and responses of the patients treated in the dose-finding
phase.
To estimate the efficacy of CM4620 to prevent pseudocyst or necrotizing pancreatitis in
children with AAP.
Secondary Objectives
To determine the effect of CM4620 on the incidence of severe pancreatitis
To determine the effect of CM4620 on the incidence of Systemic Inflammatory Response Syndrome
(SIRS).