Hemostasis During Asparaginase Treatment in Acute Lymphoblastic Leukemia(ALL)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2010 by Aarhus University Hospital
Sponsor:
Information provided by:
Aarhus University Hospital
ClinicalTrials.gov Identifier:
NCT01094392
First received: March 17, 2010
Last updated: March 26, 2010
Last verified: March 2010
  Purpose

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
Acute Lymphoblastic Leukemia

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Influence on Hemostasis During Prolonged Asparaginase Treatment in Childhood and Adolescent ALL

Resource links provided by NLM:


Further study details as provided by Aarhus University Hospital:

Primary Outcome Measures:
  • Description of the coagulation parameters [ Time Frame: December 2016 ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 250
Study Start Date: March 2010
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
treatment every 6th week during 6 months
treatment every 2nd week during 6 months

  Eligibility

Ages Eligible for Study:   1 Year to 18 Years
Genders Eligible for Study:   Both
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
  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: 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
  More Information

No publications provided

Responsible Party: Ph.D. M.D. Birgitte Klug Albertsen, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT01094392     History of Changes
Other Study ID Numbers: Hemostasis-NOPHO
Study First Received: March 17, 2010
Last Updated: March 26, 2010
Health Authority: Denmark: Ethics Committee
Denmark: Danish Dataprotection Agency

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

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

ClinicalTrials.gov processed this record on October 21, 2014