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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

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.

Description

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

Conditions

Acute Lymphoblastic Leukemia

Intervention

Liposomal cytarabine, Intrathecal triple

Location

Department of Pediatrics, Rigshospitalet
Copenhagen
Denmark
2100

Status

Recruiting

Source

Nordic Society for Pediatric Hematology and Oncology

Results (where available)

View Results

Links

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

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