Liposomal Cytarabine for Central Nervous System (CNS)-Treatment in High-risk Acute Lymphoblastic Leukemia (ALL)

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

• 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.

Inclusion Criteria:

• High risk acute lymphoblastic leukemia
• Not eligible for bone marrow transplantation
• Age 1-18
• Written informed consent has been obtained

Exclusion Criteria:

• 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