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CM4620 for Pancreatitis

Q: Are patients being actively sought for this clinical trial?

This trial, as indicated by clinicaltrials.gov is still recruiting patients. The listing for this study was first made on September 4th, 2020 with the most recent update being June 15th, 2022.

Q: How many total participants are in this clinical trial?

Yes, the trial is currently open for enrollment. According to the listing on clinicaltrials.gov, the study was first posted on September 4th 2020 and was last updated June 15th 2022. They are recruiting for a total of 42 patients at 1 location.

Q: What are the goals that this research is looking to achieve?

The success of this study will be determined by the number of CTCAE grade 3-5 events, which will be measured over a month-long period. Other indicators of CM4620's efficacy include pseudocyst levels and the incidence of systemic inflammatory response syndrome.

Phase 1 & 2

Recruiting

Led By Seth E. Karol, MD

Research Sponsored by St. Jude Children's Research Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient with acute lymphoblastic leukemia/ lymphoma age < 22 years receiving therapy with curative intent.

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48-72 hours after study entry

Awards & highlights

Study Summary

This trial is testing a new drug, CM4620, to see if it's safe and effective in reducing the severity of pancreatitis in children.

Who is the study for?

This trial is for children and young adults under 22 with acute lymphoblastic leukemia/lymphoma who are undergoing treatment. They must have recent pancreatitis linked to asparaginase therapy, no history of egg allergy or sensitivity to CM4620 components, normal kidney and liver function tests, no other investigational drugs taken in the last week, no prior pancreatitis episodes, a safe QTc interval on ECG, not be pregnant or breastfeeding, and agree to use contraception.Check my eligibility

What is being tested?

The study is testing CM4620's safety and ability to reduce the severity of pancreatitis caused by asparaginase in young patients. It will look at what doses are safe (phase I) and how well it works to prevent serious complications like pseudocysts or necrotizing pancreatitis (phase II).See study design

What are the potential side effects?

While specific side effects of CM4620 aren't listed here, common ones may include allergic reactions due to egg-derived components in the drug formulation. The trial will monitor for any dose-limiting toxicities.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am under 22 and being treated for acute lymphoblastic leukemia/lymphoma with the goal of curing it.

Select...

I have acute pancreatitis with high enzyme levels and either pain or imaging that confirms it.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48-72 hours after study entry

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~48-72 hours after study entry

This trial's timeline: 3 weeks for screening, Varies for treatment, and 48-72 hours after study entry for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Responses to CM4620

The number of CTCAE grade 3-5 events

Secondary outcome measures

Effect of CM4620 measured by levels of pancreatic enzymes

Effect of CM4620: Incidence of SIRS

Effect of CM4620: Necrosis

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: CM4620 TreatmentExperimental Treatment1 Intervention

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

St. Jude Children's Research HospitalLead Sponsor

428 Previous Clinical Trials

5,306,571 Total Patients Enrolled

CalciMedica, Inc.Industry Sponsor

7 Previous Clinical Trials

687 Total Patients Enrolled

3 Trials studying Acute Pancreatitis

244 Patients Enrolled for Acute Pancreatitis

Seth E. Karol, MDPrincipal InvestigatorSt. Jude Children's Research Hospital

3 Previous Clinical Trials

999 Total Patients Enrolled

Media Library

CM4620 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04195347 — Phase 1 & 2

Acute Pancreatitis Research Study Groups: CM4620 Treatment

Acute Pancreatitis Clinical Trial 2023: CM4620 Highlights & Side Effects. Trial Name: NCT04195347 — Phase 1 & 2

CM4620 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04195347 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are patients being actively sought for this clinical trial?

"This trial, as indicated by clinicaltrials.gov is still recruiting patients. The listing for this study was first made on September 4th, 2020 with the most recent update being June 15th, 2022."

Answered by AI

How many total participants are in this clinical trial?

"Yes, the trial is currently open for enrollment. According to the listing on clinicaltrials.gov, the study was first posted on September 4th 2020 and was last updated June 15th 2022. They are recruiting for a total of 42 patients at 1 location."

Answered by AI

What are the goals that this research is looking to achieve?

"The success of this study will be determined by the number of CTCAE grade 3-5 events, which will be measured over a month-long period. Other indicators of CM4620's efficacy include pseudocyst levels and the incidence of systemic inflammatory response syndrome."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2020. "Study of CM4620 to Reduce the Severity of Pancreatitis Due to Asparaginase". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04195347.

All > Chronic Pancreatitis