Status:
SUSPENDED
Liposomal Cytarabine for Central Nervous System (CNS)-Treatment in High-risk Acute Lymphoblastic Leukemia (ALL)
Lead Sponsor:
Nordic Society for Pediatric Hematology and Oncology
Collaborating Sponsors:
Oulu University Hospital
Conditions:
Acute Lymphoblastic Leukemia
Eligibility:
All Genders
1-18 years
Phase:
PHASE3
Brief Summary
* Replacement of intrathecal Triple (methotrexate, cytarabine, prednisolone) with intrathecal liposomal cytarabine and prednisolone during maintenance therapy will decrease the CNS relapse rate in hig...
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
- High risk acute lymphoblastic leukemia
- Not eligible for bone marrow transplantation
- Age 1-18
- Written informed consent has been obtained
Exclusion
- Persistent NCI grade 3-4 neurotoxicity from previous treatments
- Bilineage ALL
- Leukemia predisposing syndromes (e.g. Downs syndrome, Ataxia Telangiectasia)
- Previous cancer
- Known intolerance to NOPHO ALL 2008 anticancer agents
- Sexually active females will use safe contraceptives
- Previous treatment with intrathecal liposomal cytarabine
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2018
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00991744
Start Date
January 1 2009
End Date
December 1 2018
Last Update
October 10 2012
Active Locations (5)
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1
Department of Pediatrics, Rigshospitalet
Copenhagen, Denmark, 2100
2
Helsinki University Hospital
Helsinki, Finland
3
University of Reykjavik, Iceland
Reykjavik, Iceland
4
University Hospital of Trondheim, Norway
Trondheim, Norway