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Liposomal Cytarabine vs Intrathecal Triple in High-Risk ALL
NCT00991744Phase 3
Key facts
- Status
- Suspended
- Start
- Jan 2009
- Primary completion
- Dec 2018
- Countries
- 5
- Sponsor
- Nordic Society for Pediatric Hematology and Oncology
- Modality
- Targeted Liposomes, Stealth (PEGylated) Liposomes, Conventional Liposomes
- Drugs
- liposomal cytarabine
- Conditions
- acute lymphoblastic leukemia (ALL)
01
Overview
Phase 3, randomised, open-label trial of liposomal cytarabine in acute lymphoblastic leukemia (ALL) (2 arms), sponsored by Nordic Society for Pediatric Hematology and Oncology. Primary endpoint: Number of leukemia relapses in the central nervous system at 5 years. Started Jan 2009; status: suspended.
02
Design
2 arms- Study design
- RandomizedOpen-label
Liposomal cytarabine
Intrathecal liposomal cytarabine + prednisolone + oral dexamethasone
Intrathecal triple
Intrathecal methotrexate + cytarabine + prednisolone
03
Who it enrols
High-risk ALL patients aged 1-18 not eligible for bone marrow transplantation.
04
Endpoints
Primary
Number of leukemia relapses in the central nervous system
Secondary
Neurological toxicity
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