Actively Recruiting
Study of CM4620 to Reduce the Severity of Pancreatitis Due to Asparaginase
Led by St. Jude Children's Research Hospital · Updated on 2026-04-24
42
Participants Needed
2
Research Sites
434 weeks
Total Duration
On this page
Sponsors
S
St. Jude Children's Research Hospital
Lead Sponsor
C
CalciMedica, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Study of CM4620 to Reduce the Severity of Pancreatitis Due to Asparaginase
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Acute pancreatitis with amylase or lipase elevated at least 3 times the upper limit of normal plus abdominal pain or imaging consistent with pancreatitis
- Received any form of asparaginase within the prior 49 days
- Patient with acute lymphoblastic leukemia or lymphoma under 22 years old receiving curative therapy
You will not qualify if you...
- Prior episode of pancreatitis
- Baseline QTc interval greater than 450 milliseconds
- Creatinine or total bilirubin more than 3 times the upper limit of normal without leukemic infiltrate or hemolysis
- Received another investigational agent within 7 days prior to enrollment
- Allergy to eggs or known hypersensitivity to any component of CM4620
- Positive pregnancy test or breastfeeding; females of childbearing potential must have negative pregnancy test and agree to use effective contraception for 12 months post-therapy
- Inability or unwillingness of participant or guardian to provide written informed consent
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Novant Health Presbyterian Hemby Children's Hospital
Charlotte, North Carolina, United States, 28204
Actively Recruiting
2
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Actively Recruiting
Research Team
S
Seth E. Karol, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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