Study of CM4620 to Reduce the Severity of Pancreatitis Due to Asparaginase
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|ClinicalTrials.gov Identifier: NCT04195347|
Recruitment Status : Recruiting
First Posted : December 11, 2019
Last Update Posted : April 19, 2022
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.
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.
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).
|Condition or disease||Intervention/treatment||Phase|
|Acute Pancreatitis||Drug: CM4620||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||CRSPA: Phase I/II Study of CM4620 to Reduce the Severity of Pancreatitis Due to Asparaginase|
|Actual Study Start Date :||September 4, 2020|
|Estimated Primary Completion Date :||June 2023|
|Estimated Study Completion Date :||December 2023|
Experimental: CM4620 Treatment
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
Patients will receive CM4620 IV on days 1-4 at the recommended Phase II dose (RP2D) as determined in Phase I.
Other Name: CM4620-IE
- The number of CTCAE grade 3-5 events [ Time Frame: Within 28 days of receiving the medication ]Drug safety measuring the number of CTCAE grade 3-5 events
- Responses to CM4620 [ Time Frame: 28-35 days after study entry. ]We will evaluate the rate of pancreatic necrosis or pseudocyst formation using radiographic imaging
- Effect of CM4620 measured by levels of pancreatic enzymes [ Time Frame: 72 hours after study entry ]Pancreatitis measured by levels of pancreatic enzymes
- Effect of CM4620: Necrosis [ Time Frame: 28-35 days from study entry ]Necrosis measured by levels of pancreatic enzymes
- Effect of CM4620: Pseudocyst [ Time Frame: 28-35 days from study entry ]Pseudocyst measured by levels of pancreatic enzymes
- Effect of CM4620: Incidence of SIRS [ Time Frame: 48-72 hours after study entry ]Presence or absence of systemic inflammatory response syndrome
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04195347
|Contact: Seth E. Karol, MDfirstname.lastname@example.org|
|United States, Tennessee|
|St. Jude Children's Research Hospital||Recruiting|
|Memphis, Tennessee, United States, 38105|
|Contact: Seth E. Karol, MD 866-278-5833 email@example.com|
|Principal Investigator: Seth E. Karol, MD|
|Principal Investigator:||Seth E. Karol, MD||St. Jude Children's Research Hospital|