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

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ClinicalTrials.gov Identifier: NCT01393249
Recruitment Status : Completed
First Posted : July 13, 2011
Last Update Posted : December 9, 2016
Sponsor:
Collaborator:
Technical University of Denmark
Information provided by (Responsible Party):
Kjeld Schmiegelow, Rigshospitalet, Denmark

Study Description
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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
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

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


Outcome Measures
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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
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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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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    Key Record Dates
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