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CM4620 for Pancreatitis

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.

Must not have

Prior episode of pancreatitis.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48-72 hours after study entry

Awards & highlights

No Placebo-Only Group

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.

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).

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had pancreatitis before.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Responses to CM4620

The number of CTCAE grade 3-5 events

Secondary study objectives

Effect of CM4620 measured by levels of pancreatic enzymes

Effect of CM4620: Incidence of SIRS

Effect of CM4620: Necrosis

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 3Eligibility criteria met