Study of CM4620 to Reduce the Severity of Pancreatitis Due to Asparaginase

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 estim

Trial Details

NCT ID
NCT04195347
Phase
PHASE1 / PHASE2
Sponsor
St. Jude Children's Research Hospital
Status
RECRUITING
Cancer Type
Pancreatic Cancer
Interventions
  • CM4620
Locations (sample)
  • Charlotte, North Carolina, United States|35.22709,-80.84313
  • Cincinnati, Ohio, United States|39.12711,-84.51439
  • Memphis, Tennessee, United States|35.14953,-90.04898

Key Eligibility 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 pancr…
  • 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.

For full eligibility, visit ClinicalTrials.gov.

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