Status:
COMPLETED
ALL2008 Protocol for Childhood Acute Lymphoblastic Leukemia Intermittent Versus Continuous PEG Asparaginase
Lead Sponsor:
Rigshospitalet, Denmark
Collaborating Sponsors:
Nordic Society for Pediatric Hematology and Oncology
Conditions:
Acute Lymphoblastic Leukemia
Eligibility:
All Genders
1-45 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to investigate if intramuscular PEG-asparaginase administered either at six or two week intervals from day 92 until 8 months from diagnosis for patients with non-HR ALL wi...
Detailed Description
20% of children with ALL still fails to be cured. The ALL-2008 protocol is a treatment and research protocol that aims to improve the overall outcome of Nordic children and adolescents with ALL in com...
Eligibility Criteria
Inclusion
- Childhood ALL
- All mandatory biological data are available6
- Written informed consent has been obtained
Exclusion
- Bilineage ALL
- Pre-treatment with glucocorticosteroids or other antileukemic agents for more than 1 week
- ALL predisposition syndromes
- Previous cancer
- Off protocol administration of additional chemotherapy during induction therapy
- Sexually active females not using contraception
- No allergic reactions to PEG Asparaginase
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 2 2016
Estimated Enrollment :
650 Patients enrolled
Trial Details
Trial ID
NCT00819351
Start Date
January 1 2009
End Date
March 2 2016
Last Update
April 21 2017
Active Locations (6)
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1
Department of Pediatrics, Rigshospitalet
Copenhagen, Denmark, 2100
2
Helsinki University Hospital
Helsinki, Finland
3
University Hospital Reykjavik, Iceland
Reykjavik, Iceland
4
Trondheim University Hospital
Trondheim, Norway