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

Information source: Nordic Society for Pediatric Hematology and Oncology
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Lymphoblastic Leukemia

Intervention: Liposomal cytarabine (Drug); Intrathecal triple (Drug)

Phase: Phase 3

Status: Suspended

Sponsored by: Nordic Society for Pediatric Hematology and Oncology

Official(s) and/or principal investigator(s):
Arja Harila-Saari, MD, Principal Investigator, Affiliation: Oulu University Hospital


- 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.

Clinical Details

Official title: Phase III Randomised Study on Liposomal Cytarabine (DepoCyteŽ) vs. Intrathecal Triple for CNS-Treatment During Maintenance Therapy in High-Risk Acute Lymphoblastic Leukemia Patients in NOPHO ALL 2008 Treatment Protocol

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Number of leukemia relapses in the central nervous system

Secondary outcome: Neurological toxicity

Detailed 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.


Minimum age: 1 Year. Maximum age: 18 Years. Gender(s): Both.


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

Locations and Contacts

Department of Pediatrics, Rigshospitalet, Copenhagen 2100, Denmark

Helsinki University Hospital, Helsinki, Finland

University of Reykjavik, Iceland, Reykjavik, Iceland

University Hospital of Trondheim, Norway, Trondheim, Norway

Department of Pediatrics, Drottning Sylvias Pediatric Hospital, Gothenburg, Sweden

Additional Information

Home page of NOPHO - most areas are closed

Starting date: January 2009
Last updated: October 6, 2012

Page last updated: August 20, 2015

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