Liposomal Cytarabine Versus Intrathecal Triple for Central Nervous System (CNS)-Treatment During Maintenance Therapy in High-risk Acute Lymphoblastic Leukemia (ALL) Patients

2014-08-27 03:18:47 | BioPortfolio


- 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.

Study Design

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

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:18:47-0400

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