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

Sponsor
Nordic Society for Pediatric Hematology and Oncology (Other)
Overall Status
Suspended
CT.gov ID
NCT00991744
Collaborator
Oulu University Hospital (Other)
100
Enrollment
5
Locations
2
Arms
119
Duration (Months)
20
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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
  • 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.

Study Design

Study Type:
Interventional
Anticipated 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 :
Jan 1, 2009
Anticipated Primary Completion Date :
Dec 1, 2018
Anticipated Study Completion Date :
Dec 1, 2018

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of leukemia relapses in the central nervous system [5 years]

    Secondary Outcome Measures

    1. Neurological toxicity [6 months after cessation of leukemia therapy]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year to 18 Years
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Pediatrics, Rigshospitalet Copenhagen Denmark 2100
    2 Helsinki University Hospital Helsinki Finland
    3 University of Reykjavik, Iceland Reykjavik Iceland
    4 University Hospital of Trondheim, Norway Trondheim Norway
    5 Department of Pediatrics, Drottning Sylvias Pediatric Hospital Gothenburg Sweden

    Sponsors and Collaborators

    • Nordic Society for Pediatric Hematology and Oncology
    • Oulu University Hospital

    Investigators

    • Principal Investigator: Arja Harila-Saari, MD, Oulu University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Arja Harila-Saari, Associate professor, Nordic Society for Pediatric Hematology and Oncology
    ClinicalTrials.gov Identifier:
    NCT00991744
    Other Study ID Numbers:
    • NOPHOALL2008-DepoCyte
    First Posted:
    Oct 8, 2009
    Last Update Posted:
    Oct 10, 2012
    Last Verified:
    Oct 1, 2012
    Keywords provided by Arja Harila-Saari, Associate professor, Nordic Society for Pediatric Hematology and Oncology
    Leukemia
    Central nervous system
    Neurotoxicity
    Liposomal cytarabine
    Children
    Acute lymphoblastic leukemia
    Childhood acute lymphoblastic leukemia
    Intrathecal
    Efficacy
    Safety
    Additional relevant MeSH terms:
    Leukemia
    Precursor Cell Lymphoblastic Leukemia-Lymphoma
    Leukemia, Lymphoid
    Cytarabine
    Cortisone
    Prednisolone
    Methylprednisolone Acetate
    Methylprednisolone
    Methylprednisolone Hemisuccinate
    Prednisolone acetate
    Prednisolone hemisuccinate
    Prednisolone phosphate

    Study Results

    No Results Posted as of Oct 10, 2012