PEG-Asparaginase Associated Pancreatitis, Hepatotoxicity and Hyperlipidemia in Children With ALL (AAP2008)

Study Description

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

The purpose of this study is to create a model enabling us to predict pancreatitis, hyperlipidemia and hepatotoxicity during treatment with PEG-Asparaginase in children with Acute Lymphoblastic Leukemia.

Condition or disease
Acute Lymphoblastic Leukemia; Pancreatitis

Detailed Description:

Leukemia is the leading cause of cancer in children in Europe and the U.S. with an annual incidence of appoximately 3,5 cases per 100.000 children 0-14,9 years.

Although the rate of cure has increased significantly, treatment is still unsuccesfull in appoximately 20 % of the patients. There is great variation in the how the individual patient processes the different chemotherapeutic agents. Furthermore there is a signifikant difference regarding the severity of sideeffects and toxicities. So far it has not been possible to predict which patients are at speciel risk of developing toxicities.

Acute pancreatitis is a severe sideffect/toxicity when treating ALL. Patients are at risk of developing pancreatitis, because of the drug Asparaginase. The condition can not be prevented and in severe cases, e.g. hemorhaggic pancreatitis the only solution is to discontinue the drug, in spite of the fact that Asparaginase is on of the most important drugs when treating leukemia.

In the current study we will map the occurence of pancreatitis, hepatotoxicity and hyperlipidemia among approximately 1000 children and adolescents with leukemia. This study is unique because it is the largest study of its kind regarding Asparaginase associated pancreatitis. Among other things it will involve extensive genetic analysis.

We believe that this study will improve the possibilities, not only, for individualized treatmentVi mener at dette studie vil forbedre mulighederne for individ orienteret behandling, but also for other studies like this regarding other toxicities in patients with cancer.

Study Design

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Observational
Actual Enrollment :	31 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	PEG-Asparaginase Associated Pancreatitis, Hepatotoxicity and Hyperlipidemia in Children With ALL
Study Start Date :	July 2011
Actual Primary Completion Date :	December 2013
Actual Study Completion Date :	June 2014

Groups and Cohorts

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
ALL, Asparaginase, pancreatitis; Patients that have been scanned and have had blood tests

Outcome Measures

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Risk of pancreatitis [ Time Frame: During asparaginase therapy ]
   Risk of pancreatitis in relation to host genomic variants, inflammatory markers and ultrasound changes in the weeks prior to clinical pancreatitia

Secondary Outcome Measures :

1. Course of pancreatitis [ Time Frame: In the months following pancreatitis ]

   Risk of complications, specifically cysts, pain and diabetes in the months following pancratitis.

   Risk of 2nd episode of pancreatitis if reexposed to asparaginase

Eligibility Criteria

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	1 Year to 18 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Children aged 1-17.9, diagnosed with ALL and undergoing treatment with Peg-Asparaginase.

Criteria

Inclusion Criteria:

• IR- or SR- type ALL, and treatment with Peg-Asparaginase

Exclusion Criteria:

• HR ALL, and changing subgroup from IR or SR to HR

Contacts and Locations

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Denmark
Rigshospitalet
Copenhagen, Denmark, 2100

Sponsors and Collaborators

Rigshospitalet, Denmark

Technical University of Denmark

Investigators

Study Chair:	Kjeld Schmiegelow, M.D.	Rigshospitalet, Denmark

More Information

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Kjeld Schmiegelow, Professor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:	NCT01393249 History of Changes
Other Study ID Numbers:	RR240778PEGASP; H2-2010-002 ( Registry Identifier: VEK RegionH )
First Posted:	July 13, 2011
Last Update Posted:	December 9, 2016
Last Verified:	December 2016

Keywords provided by Kjeld Schmiegelow, Rigshospitalet, Denmark:

Acute Lymphoblastic Leukemia; Pediatric; Asparaginase; Pancreatitis

Additional relevant MeSH terms:

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Pancreatitis; Hyperlipidemias; Hyperlipoproteinemias; Leukemia; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases	Immunoproliferative Disorders; Immune System Diseases; Pancreatic Diseases; Digestive System Diseases; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Pegaspargase; Asparaginase; Antineoplastic Agents