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Study of CM4620 to Reduce the Severity of Pancreatitis Due to Asparaginase
Sponsor: St. Jude Children's Research Hospital
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).
Official title: CRSPA: Phase I/II Study of CM4620 to Reduce the Severity of Pancreatitis Due to Asparaginase
Key Details
Gender
All
Age Range
Any - 21 Years
Study Type
INTERVENTIONAL
Enrollment
42
Start Date
2020-09-04
Completion Date
2029-01
Last Updated
2025-12-23
Healthy Volunteers
No
Conditions
Interventions
CM4620
IV
Locations (2)
Novant Health Presbyterian Hemby Children's Hospital
Charlotte, North Carolina, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, United States