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RecruitingPhase 1 / Phase 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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
Up to 21 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 4 months
  • Procedures mentioned: Infusions

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "CM4620 will be given days 1-4 as an IV infusion beginning within 36 hours of the onset of acute pancreatitis associated abdominal pain and within 8 hours of enrollment."
  • "Patients will be followed for about 4 months after treatment."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety of CM4620 and whether it can make sudden swelling of the pancreas less severe. It is for children and young adults under age 22 with acute lymphoblastic leukemia or lymphoma who developed this problem after taking asparaginase during cancer treatment.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have sudden swelling of the pancreas, with amylase or lipase blood levels at least 3 times the upper normal limit, plus belly pain or scan results that show this problem.
  • Have received any form of asparaginase in the past 49 days.
  • Be under age 22, have acute lymphoblastic leukemia or lymphoma, and be receiving treatment meant to cure the cancer.

Who can't join

  • Have had swelling of the pancreas before.
  • Have a QTc over 450 milliseconds before treatment. QTc measures part of the heart’s electrical rhythm.
  • Have creatinine or total bilirubin blood levels over 3 times the upper normal limit for your age, without signs of leukemia cells in the organs or breakdown of red blood cells. These tests help check kidney and liver health.
  • Have received another study drug in the past 7 days.
  • Have an egg allergy or a known allergy to any part of CM4620.
  • Are pregnant or breastfeeding. Females who could become pregnant must have a negative pregnancy test before joining.
  • Do not agree to use effective birth control for at least 12 months after treatment ends, if you or your partner could become pregnant.
  • You or your legal guardian or representative cannot or will not give written consent to join.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (3)

NC

OH

TN