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

Phase

1/2

Condition

Pancreatitis

Treatment

CM4620

Clinical Study ID

NCT04195347

CRSPA

NCI-2019-08205

Ages < 21
All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

Acute pancreatitis with elevation of amylase OR lipase ≥ 3x the upper limit ofnormal AND at least 1 of: abdominal pain consistent with acute pancreatitis ORimaging 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 therapywith curative intent.

Exclusion

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 upperlimit 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 musthave a negative urine or serum pregnancy test prior to enrollment. Males and femalesof childbearing potential must agree to use effective contraception for at leasttwelve months following the completion of therapy.
Inability or unwillingness of research participant or legal guardian/representativeto give written informed consent.

Study Design

CM4620

1/2

September 04, 2020

January 31, 2029

Study Description

This is an open label safety and efficacy evaluation with comparison of toxicity to a historical control population (TOTXVI). There will be 3 cohorts of patients enrolled, and the dose for each cohort will be determined based on the toxicities experienced in the ongoing and prior cohorts.

An initial 9 patients (cohort 1) will be enrolled and will receive dose level 1 and monitored for toxicity. If the therapy is well tolerated, 6 patients (cohort 2) will be treated at dose level 2. Subsequent enrollment of 9 patients (cohort 3) will be at either dose level 1 or 2 based on tolerability. The keyboard design will be used to determine the dosing for cohorts 2 and 3. Additional patients will be enrolled at the recommended phase II dose (RP2D) until a total of 24 patients have been treated at that dose, including any treated during the dose-finding phase.

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. For patients with prior abdominal pain or in those unable to communicate the location/characteristic of their pain, a change in the characteristic of the pain or new enzyme elevation/imaging findings after previously normal studies will determine the timing of onset of pancreatitis.

Patients will be followed for about 4 months after treatment.

Connect with a study center

Novant Health Presbyterian Hemby Children's Hospital
Charlotte, North Carolina 28204
United States
Active - Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio 45220
United States
Active - Recruiting
St. Jude Children's Research Hospital
Memphis, Tennessee 38105
United States
Active - Recruiting

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