Phase III Randomised Study on Liposomal Cytarabine (DepoCyte®) vs. Intrathecal Triple for CNS-Treatment During Maintenance Therapy in High-Risk Acute Lymphoblastic Leukemia Patients in NOPHO ALL 2008 Treatment Protocol
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, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of leukemia relapses in the central nervous system
Arja Harila-Saari, MD
Oulu University Hospital
Denmark: Danish Medicines Agency