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

• Status: Suspended
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

Summary

• 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nordic Society for Pediatric Hematology and Oncology
• Collaborator: Oulu University Hospital
• Treatments: Cortisone; Cortisone acetate; Cytarabine; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

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