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

This study has suspended participant recruitment.
(Sterility problems in DepoCyte production)
Sponsor:
Collaborator:
Oulu University Hospital
Information provided by (Responsible Party):
Arja Harila-Saari, Nordic Society for Pediatric Hematology and Oncology
ClinicalTrials.gov Identifier:
NCT00991744
First received: October 7, 2009
Last updated: October 6, 2012
Last verified: October 2012
  Purpose
  • 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 Intervention Phase
Acute Lymphoblastic Leukemia
Drug: Liposomal cytarabine
Drug: Intrathecal triple
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Nordic Society for Pediatric Hematology and Oncology:

Primary Outcome Measures:
  • Number of leukemia relapses in the central nervous system [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Neurological toxicity [ Time Frame: 6 months after cessation of leukemia therapy ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: January 2009
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   1 Year to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00991744

Locations
Denmark
Department of Pediatrics, Rigshospitalet
Copenhagen, Denmark, 2100
Finland
Helsinki University Hospital
Helsinki, Finland
Iceland
University of Reykjavik, Iceland
Reykjavik, Iceland
Norway
University Hospital of Trondheim, Norway
Trondheim, Norway
Sweden
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
  More Information

Additional Information:
No publications provided

Responsible Party: Arja Harila-Saari, Associate professor, Nordic Society for Pediatric Hematology and Oncology
ClinicalTrials.gov Identifier: NCT00991744     History of Changes
Other Study ID Numbers: NOPHOALL2008-DepoCyte
Study First Received: October 7, 2009
Last Updated: October 6, 2012
Health Authority: Denmark: Danish Medicines Agency
Denmark: The Danish National Committee on Biomedical Research Ethics
Finland: National Advisory Board on Health Care Ethics
Finland: Finnish Medicines Agency
Iceland: Icelandic Medicines Control Agency
Norway: Norwegian Medicines Agency
Norway:National Committee for Medical and Health Research Ethics
Sweden: Swedish National Council on Medical Ethics
Sweden: Medical Products Agency

Keywords provided by 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
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cytarabine
Prednisolone
Methylprednisolone Hemisuccinate
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Inflammatory Agents
Glucocorticoids

ClinicalTrials.gov processed this record on July 28, 2014