Liposomal Cytarabine for Central Nervous System (CNS)-Treatment in High-risk Acute Lymphoblastic Leukemia (ALL)
NCT ID: NCT00991744
Last Updated: 2012-10-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
PHASE3
100 participants
INTERVENTIONAL
2009-01-31
2018-12-31
Brief Summary
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* Both acute and long-term toxicity are equal in both treatment arms.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Liposomal cytarabine
Intrathecal liposomal cytarabine (25 - 50 mg) combined with intrathecal prednisolone sodium succinate and oral dexamethasone 6 times during maintenance treatment for high-risk ALL
Liposomal cytarabine
Intrathecal liposomal cytarabine combined with intrathecal prednisolone and oral dexamethasone during maintenance treatment for high-risk ALL
Intrathecal triple
Intrathecal methotrexate, cytarabine and prednisolone
Intrathecal triple
Intrathecal methotrexate (8-12 mg), cytarabine (20 - 30 mg) and prednisolone sodium succinate (12,5 - 20 mg) 6 times during maintenance treatment in high-risk ALL protocol
Interventions
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Liposomal cytarabine
Intrathecal liposomal cytarabine combined with intrathecal prednisolone and oral dexamethasone during maintenance treatment for high-risk ALL
Intrathecal triple
Intrathecal methotrexate (8-12 mg), cytarabine (20 - 30 mg) and prednisolone sodium succinate (12,5 - 20 mg) 6 times during maintenance treatment in high-risk ALL protocol
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Not eligible for bone marrow transplantation
* Age 1-18
* Written informed consent has been obtained
Exclusion Criteria
* 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
1 Year
18 Years
ALL
No
Sponsors
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Oulu University Hospital
OTHER
Nordic Society for Pediatric Hematology and Oncology
OTHER
Responsible Party
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Arja Harila-Saari
Associate professor
Principal Investigators
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Arja Harila-Saari, MD
Role: PRINCIPAL_INVESTIGATOR
Oulu University Hospital
Locations
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Department of Pediatrics, Rigshospitalet
Copenhagen, , 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
Countries
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Other Identifiers
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NOPHOALL2008-DepoCyte
Identifier Type: -
Identifier Source: org_study_id