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RECRUITING
NCT04195347
PHASE1/PHASE2

Study of CM4620 to Reduce the Severity of Pancreatitis Due to Asparaginase

Sponsor: St. Jude Children's Research Hospital

View on ClinicalTrials.gov

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

Interventions

DRUG

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