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

Launched by ST. JUDE CHILDREN'S RESEARCH HOSPITAL · Dec 9, 2019

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ClinConnect Summary

This clinical trial, called the CM4620 study, is looking at a new treatment to help reduce the severity of pancreatitis in children and young adults who have this condition due to a medicine called asparaginase. The trial aims to find out if CM4620 is safe for patients who are also receiving cancer treatment, as well as how effective it is at preventing serious complications like pseudocyst or necrotizing pancreatitis.

To be eligible for this study, participants must be under 22 years old and have acute pancreatitis confirmed by certain tests and symptoms. They should have received asparaginase treatment within the last 35 days. Participants will be monitored closely to ensure their safety and to see how well the treatment works. If you or someone you know might be interested in joining this study, it's important to discuss it with a healthcare provider to understand the details and any potential risks involved.

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Eligibility criteria

• Inclusion Criteria:
• • Acute pancreatitis with elevation of amylase OR lipase ≥ 3x the upper limit of normal AND at least 1 of: abdominal pain consistent with acute pancreatitis OR imaging findings consistent with acute pancreatitis.
• • Receipt of any form of asparaginase within the prior 35 days.
• • Patient with acute lymphoblastic leukemia/ lymphoma age \< 22 years receiving therapy with curative intent.
• Exclusion Criteria:
• • Prior episode of pancreatitis.
• • QTc at baseline \> 450 msec.
• • Creatinine \> 3x the upper limit of normal for age or total bilirubin \>3x the upper limit for normal for age without evidence of leukemic infiltrate or hemolysis.
• • Receipt of another investigational agent within the prior 7 days.
• • History of allergy to eggs or known hypersensitivity to any component of CM4620.
• • Positive pregnancy test or breastfeeding. Females of childbearing potential must have a negative urine or serum pregnancy test prior to enrollment. Males and females of childbearing potential must agree to use effective contraception for at least twelve months following the completion of therapy.
• • Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.