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New treatment option for Acute Pancreatitis
Official title Study of CM4620 to Reduce the Severity of Pancreatitis Due to Asparaginase
ClinicalTrials.gov ID: NCT04195347
What this study is testing
What is CM4620?
CM4620 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute pancreatitis.
Also referred to as CM4620-IE.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 4 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 21
You may be able to join if
- Acute pancreatitis with elevation of amylase OR lipase ≥ 3x the upper limit of normal AND at least 1 of: abdominal pain consistent with acute...
- Receipt of any form of asparaginase within the prior 49 days.
- Patient with acute lymphoblastic leukemia/ lymphoma age \< 22 years receiving therapy with curative intent.
You likely can't join if
- Prior episode of pancreatitis.
- QTc at baseline \> 450 msec.
- Creatinine \> 3x the upper limit of normal for age or total bilirubin \>3x the upper limit for normal for age without evidence of leukemic infiltrate...
- 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 must have a negative urine or serum pregnancy test prior to enrollment...
See the full eligibility criteria
- 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.
- Receipt of any form of asparaginase within the prior 49 days.
- Patient with acute lymphoblastic leukemia/ lymphoma age \< 22 years receiving therapy with curative intent.
- Prior episode of pancreatitis.
- QTc at baseline \> 450 msec.
- Creatinine \> 3x the upper limit of normal for age or total bilirubin \>3x the upper limit 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 must have a negative urine or serum pregnancy test prior to enrollment. Males and females of childbearing potential must agree to use effective...
- Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
The study team makes the final eligibility decision.
Where it's taking place
- Charlotte, North Carolina, United States
- Cincinnati, Ohio, United States
- Memphis, Tennessee, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 4 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, up to 21 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Charlotte, North Carolina, United States; Cincinnati, Ohio, United States; Memphis, Tennessee, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.