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Hemostasis During Asparaginase Treatment in Acute Lymphoblastic Leukemia(ALL)

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ClinicalTrials.gov Identifier: NCT01094392
Recruitment Status : Recruiting
First Posted : March 29, 2010
Last Update Posted : March 4, 2016
Sponsor:
Information provided by (Responsible Party):
Birgitte Klug Albertsen, Aarhus University Hospital

Brief Summary:

Asparaginase is an important drug in the treatment of childhood leukemia. One of the rare but severe side effects to the treatment is thrombosis in or outside the central nervous system.

The aim of this study is to investigate and describe the influence on the coagulation parameters during prolonged treatment with asparaginase.

Hopefully this knowledge will help to foresee the risk of thrombosis and thus making it possible to prevent these.


Condition or disease
Acute Lymphoblastic Leukemia

Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Influence on Hemostasis During Prolonged Asparaginase Treatment in Childhood and Adolescent ALL
Study Start Date : March 2010
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020


Group/Cohort
treatment every 6th week during 6 months
treatment every 2nd week during 6 months



Primary Outcome Measures :
  1. Description of the coagulation parameters [ Time Frame: December 2016 ]
    The study is a prospective and descriptive study. Levels of coagulation parameters will be analyzed using Two Sample T-Test and the levels of asparaginase in serum will be analyzed by Chi2 test.



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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:   Non-Probability Sample
Study Population

Children and young adults (age 1-17.9 years) newly diagnosed with ALL in the Nordic Countries and treated according to the Nordic ALL-protocol NOPHO ALL-2008.

Written informed consent has been obtained

Criteria

Inclusion Criteria:

  • Childhood ALL, eligible to receive standard risk or intermediate risk therapy as described in the protocol, written informed consent has been obtained

Exclusion Criteria:

  • No allergic reactions to PEG-asparaginase

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): NCT01094392


Contacts
Contact: Birgitte K Albertsen, M.D. +45 89495566 ext 6732 biralber@rm.dk

Locations
Denmark
Aalborg Hospital Recruiting
Aalborg, Denmark, 9000
Contact: Jon Helgestad, M.D.         
Department of Pediatrics, Skejby Hospital Recruiting
Aarhus, Denmark, 8200
Contact: Birgitte K Albertsen, M.D.    +45 89495566 ext 6732    biralber@rm.dk   
Department of Pediatrics, Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
Contact: Birgitte Lausen, M.D.    +45 35458177    Birgitte.Lausen@rh.regionh.dk   
University Hospital in Odense Recruiting
Odense, Denmark, 5000
Contact: Peder S Wehner, M.D.         
Sponsors and Collaborators
Aarhus University Hospital
Investigators
Principal Investigator: Birgitte K Albertsen, Ph.D. M.D. Department of Pediatrics, Skejby Hospital, Aarhus, Denmark

Responsible Party: Birgitte Klug Albertsen, MD, PhD, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT01094392     History of Changes
Other Study ID Numbers: Hemostasis-NOPHO
First Posted: March 29, 2010    Key Record Dates
Last Update Posted: March 4, 2016
Last Verified: March 2016

Keywords provided by Birgitte Klug Albertsen, Aarhus University Hospital:
ALL
PEG-asparaginase
prolonged treatment
Thrombosis
Central venous line
Echocardiography

Additional relevant MeSH terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatics
Asparaginase
Coagulants
Antineoplastic Agents