RecruitingPhase 1Phase 2NCT04195347

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

CRSPA: Phase I/II Study of CM4620 to Reduce the Severity of Pancreatitis Due to Asparaginase

Sponsor

St. Jude Children's Research Hospital

Enrollment

42 participants

Start Date

Sep 4, 2020

Study Type

INTERVENTIONAL

Conditions

Acute Pancreatitis

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).

Eligibility

Max Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a drug called CM4620 can reduce the severity of pancreatitis (severe inflammation of the pancreas) that occurs as a side effect of asparaginase chemotherapy in young patients being treated for leukemia or lymphoma. **You may be eligible if...** - You are under 22 years old and being treated for acute lymphoblastic leukemia or lymphoma with curative intent - You received asparaginase chemotherapy within the past 49 days - You have developed acute pancreatitis (elevated amylase or lipase plus abdominal pain or imaging findings) **You may NOT be eligible if...** - You have had pancreatitis before - Your heart's electrical activity (QTc interval) is too prolonged at baseline - Your kidney or liver function is significantly impaired - You have received another experimental drug within the past 7 days - You are allergic to eggs or any component of the study drug Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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