NCT04195347RecruitingPhase 1/2
Study of CM4620 to Reduce the Severity of Pancreatitis Due to Asparaginase
CRSPA: Phase I/II Study of CM4620 to Reduce the Severity of Pancreatitis Due to Asparaginase
Source: ClinicalTrials.gov · Last updated 3 Jun 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 42 (estimated)
- First submitted
- 25 Nov 2019
- Start date
- 4 Sept 2020
- Primary completion date
- Jan 2027
- Lead sponsor
- St. Jude Children's Research Hospital
- NCT number
- NCT04195347
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 42
- From 4 Sept 2020 to the primary completion date, Jan 2027
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior episode of pancreatitis.
- Receipt of another investigational agent within the prior 7 days.
Other illness
- History of allergy to eggs or known hypersensitivity to any component of CM4620.
Lab values
- 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.
- 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.
Other
- Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
Who the study is looking for
- 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.
Age in the registry: - to 21 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Novant Health Presbyterian Hemby Children's Hospital Coordinator of this site? Confirm its status | Charlotte | United States | Recruiting |
| Cincinnati Children's Hospital Medical Center Coordinator of this site? Confirm its status | Cincinnati | United States | Recruiting |
| St. Jude Children's Research Hospital Coordinator of this site? Confirm its status | Memphis | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.