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

This study has been completed.

Sponsor:

Collaborator:

Technical University of Denmark

Information provided by (Responsible Party):

Kjeld Schmiegelow, Rigshospitalet, Denmark

ClinicalTrials.gov Identifier:

NCT01393249

First received: July 12, 2011

Last updated: December 8, 2016

Last verified: December 2016

History of Changes

Purpose

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
Acute Lymphoblastic Leukemia Pancreatitis


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	PEG-Asparaginase Associated Pancreatitis, Hepatotoxicity and Hyperlipidemia in Children With ALL

Resource links provided by NLM:

Genetics Home Reference related topics: hereditary pancreatitis

MedlinePlus related topics: Pancreatitis

Drug Information available for: Asparaginase Pegaspargase

Genetic and Rare Diseases Information Center resources: Acute Lymphoblastic Leukemia Lymphosarcoma

U.S. FDA Resources

Further study details as provided by Kjeld Schmiegelow, Rigshospitalet, Denmark:

Primary Outcome Measures:

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:

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


Enrollment:	31
Study Start Date:	July 2011
Study Completion Date:	June 2014
Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Groups/Cohorts
ALL, Asparaginase, pancreatitis Patients that have been scanned and have had blood tests

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.

Eligibility


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01393249

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


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 )
Study First Received:	July 12, 2011
Last Updated:	December 8, 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 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

ClinicalTrials.gov processed this record on June 22, 2017

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