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- Replacement of intrathecal Triple (methotrexate, cytarabine, prednisolone) with intrathecal liposomal cytarabine and prednisolone during maintenance therapy will decrease the CNS relapse rate in high-risk ALL patients.
- Both acute and long-term toxicity are equal in both treatment arms.
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 comparison with the ALL-2000 protocol and previous NOPHO protocols.
The specific and primary objectives of the randomised study is:
1. To replace intrathecal triple (methotrexate, cytarabine and glucocorticosteroid) by intrathecal liposomal cytarabine and glucocorticosteroid during maintenance therapy in order to decrease the central nervous system relapse rate in high-risk acute lymphoblastic leukemia patients.
2. To evaluate acute and long-term toxicity in both treatment arms.
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Acute Lymphoblastic Leukemia
Liposomal cytarabine, Intrathecal triple
Department of Pediatrics, Rigshospitalet
Nordic Society for Pediatric Hematology and Oncology
Published on BioPortfolio: 2014-08-27T03:18:47-0400
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