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

Part of paid clinical trials in Charlotte, North Carolina.

Sponsor
St. Jude Children's Research Hospital
Study ID
NCT04195347
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • CM4620 — DRUG
    IV

Study Details

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).

Key Dates

Start date
Sep 4, 2020
Status verified
Jun 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2029

Study Design

Enrollment
42 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: CM4620 Treatment
    Phase I: Cohort 1 patients receive CM4620 IV at dose level 1 on days 1-4. Cohort 2 patients receive CM4620 IV at dose level 2 on days 1-4. Cohort 3 patients receive CM4620 IV at either dose level 1 or 2 on days 1-4 Phase II: Patients will receive CM4620 IV on days 1-4 at the recommended Phase II dose (RP2D) as determined in Phase I.

Primary Outcome Measure

The number of CTCAE grade 3-5 events [ Time Frame: Within 28 days of receiving the medication ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Novant Health Presbyterian Hemby Children's HospitalCharlotteNorth Carolina28204
Jessica Bell, MD
[email protected]
704-384-1900
Jessica Bell, MD (PRINCIPAL_INVESTIGATOR)
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45220
Robin Morris, MD
[email protected]
513-636-2047
St. Jude Children's Research HospitalMemphisTennessee38105
Seth E. Karol, MD
[email protected]
888-226-4343
Seth E. Karol, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Charlotte, NC

By research site
Novant Health Presbyterian Hemby Children's Hospital· Charlotte, NCCincinnati Children's Hospital Medical Center· Cincinnati, OHSt. Jude Children's Research Hospital· Memphis, TN

Related Studies