Treatment for pancreatitis caused by asparaginase in young patients
CRSPA: Phase I/II Study of CM4620 to Reduce the Severity of Pancreatitis Due to Asparaginase
This study is testing a new treatment called CM4620 to see if it can help children and young adults with pancreatitis caused by asparaginase feel better and avoid serious complications.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | N/A to 21 Years |
| Sex | All |
| Sponsor | St. Jude Children's Research Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Charlotte, North Carolina and 1 other locations) |
| Trial ID | NCT04195347 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children and young adults under 22 years old with acute pancreatitis linked to asparaginase treatment.
Not a fit: Patients with a history of pancreatitis or those with certain pre-existing health conditions may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the severity of pancreatitis in young patients undergoing chemotherapy for leukemia or lymphoma.
How similar studies have performed: While this approach is novel, similar studies have shown promise in managing complications associated with chemotherapy-induced pancreatitis.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Charlotte, North Carolina and 1 other locations
- Novant Health Presbyterian Hemby Children's Hospital — Charlotte, North Carolina, 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.