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:
Nordic Society for Pediatric Hematology and Oncology
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
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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:
Drug Information available for:
Cortisone acetate
Prednisolone
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone
Prednisolone sodium phosphate
Cytarabine
Prednisolone phosphate
Prednisolone sodium succinate
Methylprednisolone sodium succinate
U.S. FDA Resources
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:
|
|
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:
|
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:
- 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.
- 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
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 May 23, 2013