Study of CM4620 to Reduce the Severity of Pancreatitis Due to Asparaginase
Recruiting
Phase 1
Phase 2
Interventional Study
Acute Pancreatitis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- Up to 21
- Sex
- Any
- Trial phase
- Phase 1/2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 42 (estimated)
- Sponsor
- St. Jude Children's Research Hospital · Other
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About This Trial
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 admi…
Trial Locations
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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.
* …
Contacts