Treatment for pancreatitis caused by asparaginase in young patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and effectiveness of CM4620 in children and young adults suffering from acute pancreatitis due to asparaginase. It is designed as a phase I/II open-label trial, where patients will receive CM4620 via IV infusion shortly after the onset of pancreatitis symptoms. The study will monitor the tolerability of the drug and assess its ability to reduce the severity of pancreatitis, including the prevention of complications such as pseudocysts and necrotizing pancreatitis. The trial will involve multiple cohorts, with dosing adjusted based on observed toxicities.

Why it matters

Who can join: the full rules

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 49 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.

Where it's running

• Novant Health Presbyterian Hemby Children's Hospital
  Charlotte, North Carolina, United States Recruiting
• Cincinnati Children's Hospital Medical Center
  Cincinnati, Ohio, United States Recruiting
• St. Jude Children's Research Hospital
  Memphis, Tennessee, United States Recruiting

Study contacts

• Principal investigator: Seth E. Karol, MD — St. Jude Children's Research Hospital
• Study coordinator: Seth E. Karol, MD
• Email: referralinfo@stjude.org
• Phone: 888-226-4343

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Fecal microbiota transplant to prevent infections after late-phase severe acute pancreatitis

  This trial will test whether giving healthy donor gut bacteria (fecal microbiota transplantation) through a feeding tube in the late phase of moderately severe or severe acute pancreatitis can prevent infectious complications.

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• How often splanchnic vein clots occur in acute pancreatitis and whether they relate to disease severity

  This project will see if people with acute pancreatitis develop blood clots in the splenic, portal, or superior mesenteric veins and whether those clots are linked to more severe illness.

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• Fecal microbiota transplant for people with moderate to severe acute pancreatitis

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  Recruiting at 2 sites Changhai Hospital · Shanghai, Shanghai Municipality and 1 other locations · NCT07153809

• Blood markers to detect infected pancreatic necrosis

  We will test whether specific blood markers can help predict or diagnose infected pancreatic necrosis in adults with necrotizing pancreatitis.

  Recruiting University of Minnesota · Minneapolis, Minnesota · NCT06899087

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.