NCT04195347 Study of CM4620 to Reduce the Severity of Pancreatitis Due to Asparaginase
| NCT ID | NCT04195347 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | St. Jude Children's Research Hospital |
| Condition | Acute Pancreatitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 42 participants |
| Start Date | 2020-09-04 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 42 participants in total. It began in 2020-09-04 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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 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.
Contact & Investigator
Seth E. Karol, MD
PRINCIPAL INVESTIGATOR
St. Jude Children's Research Hospital
Frequently Asked Questions
Who can join the NCT04195347 clinical trial?
This trial is open to participants of all sexes, up to 21 Years, studying Acute Pancreatitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04195347 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04195347 currently recruiting?
Yes, NCT04195347 is actively recruiting participants. Contact the research team at referralinfo@stjude.org for enrollment information.
Where is the NCT04195347 trial being conducted?
This trial is being conducted at Charlotte, United States, Cincinnati, United States, Memphis, United States.
Who is sponsoring the NCT04195347 clinical trial?
NCT04195347 is sponsored by St. Jude Children's Research Hospital. The principal investigator is Seth E. Karol, MD at St. Jude Children's Research Hospital. The trial plans to enroll 42 participants.