RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

CRSPA: Phase I/II Study of CM4620 to Reduce the Severity of Pancreatitis Due to Asparaginase

Quick Facts

Study Start:2020-09-04
Study Completion:2027-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04195347

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified to 21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Receipt of any form of asparaginase within the prior 35 days.
  3. * Patient with acute lymphoblastic leukemia/ lymphoma age \< 22 years receiving therapy with curative intent.
  1. * Prior episode of pancreatitis.
  2. * QTc at baseline \> 450 msec.
  3. * 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.
  4. * Receipt of another investigational agent within the prior 7 days.
  5. * History of allergy to eggs or known hypersensitivity to any component of CM4620.
  6. * 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.
  7. * Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.

Contacts and Locations

Study Contact

Seth E. Karol, MD
CONTACT
866-278-5833
referralinfo@stjude.org

Principal Investigator

Seth E. Karol, MD
PRINCIPAL_INVESTIGATOR
St. Jude Children's Research Hospital

Study Locations (Sites)

Novant Health Presbyterian Hemby Children's Hospital
Charlotte, North Carolina, 28204
United States
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
United States

Collaborators and Investigators

Sponsor: St. Jude Children's Research Hospital

  • Seth E. Karol, MD, PRINCIPAL_INVESTIGATOR, St. Jude Children's Research Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-09-04
Study Completion Date2027-12

Study Record Updates

Study Start Date2020-09-04
Study Completion Date2027-12

Terms related to this study

Keywords Provided by Researchers

  • Acute Pancreatitis
  • Asparaginase
  • Asparaginase Associated Pancreatitis
  • Acute Lymphoblastic Leukemia
  • Acute Lymphoblastic Lymphoma
  • CM4620
  • Children
  • SIRS
  • Systemic Inflammatory Response
  • Young Adults

Additional Relevant MeSH Terms

  • Acute Pancreatitis