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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Rigshospitalet, Denmark
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: June 30, 2013
Last verified: June 2013
  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:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Risk of pancreatitis [ Time Frame: During asparaginase therapy ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]

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

    Risk of 2nd episode of pancreatitis if reexposed to asparaginase



Estimated Enrollment: 40
Study Start Date: July 2011
Estimated Study Completion Date: December 2013
Estimated 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
Genders Eligible for Study:   Both
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

Contacts
Contact: Raheel Raja, M.D. +45 26137089 raja_sahib@yahoo.com
Contact: Kjeld Schmiegelow, Professor +35451357 kjeld.schmiegelow@rh.dk

Locations
Denmark
Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
Contact: Raheel Raja, M.D.    +4526137089    raja_sahib@yahoo.com   
Contact: Kjeld Schmiegelow, Professor    +453545131357    kjeld.schmiegelow@rh.dk   
Principal Investigator: Raheel Raja, M.D.         
Sponsors and Collaborators
Rigshospitalet, Denmark
Technical University of Denmark
Investigators
Study Chair: Kjeld Schmiegelow, M.D. Rigshospitalet, Denmark
  More Information

No publications provided

Responsible Party: Kjeld Schmiegelow, Professor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01393249     History of Changes
Other Study ID Numbers: RR240778PEGASP, H2-2010-002
Study First Received: July 12, 2011
Last Updated: June 30, 2013
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Rigshospitalet, Denmark:
Acute Lymphoblastic Leukemia
Pediatric
Asparaginase
Pancreatitis

Additional relevant MeSH terms:
Hyperlipidemias
Leukemia
Leukemia, Lymphoid
Pancreatitis
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Digestive System Diseases
Dyslipidemias
Immune System Diseases
Immunoproliferative Disorders
Lipid Metabolism Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Metabolic Diseases
Neoplasms
Neoplasms by Histologic Type
Pancreatic Diseases
Asparaginase
Pegaspargase
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014