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Trial record 87 of 93 for:    "Acute Lymphoblastic Leukemia, Childhood" | "Autonomic Agents"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00991744
Recruitment Status : Suspended (Sterility problems in DepoCyte production)
First Posted : October 8, 2009
Last Update Posted : October 10, 2012
Oulu University Hospital
Information provided by (Responsible Party):
Arja Harila-Saari, Nordic Society for Pediatric Hematology and Oncology

Brief 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.

Condition or disease Intervention/treatment Phase
Acute Lymphoblastic Leukemia Drug: Liposomal cytarabine Drug: Intrathecal triple Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase III Randomised Study on Liposomal Cytarabine (DepoCyte®) vs. Intrathecal Triple for CNS-Treatment During Maintenance Therapy in High-Risk Acute Lymphoblastic Leukemia Patients in NOPHO ALL 2008 Treatment Protocol
Study Start Date : January 2009
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
Experimental: 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
Drug: Liposomal cytarabine
Intrathecal liposomal cytarabine combined with intrathecal prednisolone and oral dexamethasone during maintenance treatment for high-risk ALL
Other Names:
  • Cytarbine
  • Ara-C
  • Cytosar-U
  • Cytosine arabinoside
  • Precortalon
  • Di-Adreson F

Active Comparator: Intrathecal triple
Intrathecal methotrexate, cytarabine and prednisolone
Drug: 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 Names:
  • DepoCyte
  • DepoCyt
  • Precortalon
  • Di-Adreson-F
  • Cytarabine
  • Ara-C
  • Cytosar-U
  • Cytosine arabinoside

Primary Outcome Measures :
  1. Number of leukemia relapses in the central nervous system [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Neurological toxicity [ Time Frame: 6 months after cessation of leukemia therapy ]

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00991744

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Department of Pediatrics, Rigshospitalet
Copenhagen, Denmark, 2100
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
Sponsors and Collaborators
Nordic Society for Pediatric Hematology and Oncology
Oulu University Hospital
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Principal Investigator: Arja Harila-Saari, MD Oulu University Hospital

Additional Information:
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Responsible Party: Arja Harila-Saari, Associate professor, Nordic Society for Pediatric Hematology and Oncology Identifier: NCT00991744     History of Changes
Other Study ID Numbers: NOPHOALL2008-DepoCyte
First Posted: October 8, 2009    Key Record Dates
Last Update Posted: October 10, 2012
Last Verified: October 2012
Keywords provided by Arja Harila-Saari, Nordic Society for Pediatric Hematology and Oncology:
Central nervous system
Liposomal cytarabine
Acute lymphoblastic leukemia
Childhood acute lymphoblastic leukemia
Additional relevant MeSH terms:
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Autonomic Agents
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Inflammatory Agents