Clinical trial NCT00991744: Liposomal Cytarabine for Central Nervous System (CNS)-Treatment in High-risk Acute Lymphoblastic Leukemia (ALL)
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 type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE3
Conditions: Acute Lymphoblastic Leukemia
Keywords: Leukemia
Central nervous system
Neurotoxicity
Liposomal cytarabine
Children
Acute lymphoblastic leukemia
Childhood acute lymphoblastic leukemia
Intrathecal
Efficacy
Safety
Lead sponsor: Nordic Society for Pediatric Hematology and Oncology
Sponsor class: OTHER
Collaborators: name: Oulu University Hospital
First posted: 2009-10-08
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Number of leukemia relapses in the central nervous system
timeFrame: 5 years
Secondary outcomes:
measure: Neurological toxicity
timeFrame: 6 months after cessation of leukemia therapy
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Pediatrics, Rigshospitalet
city: Helsinki
country: Finland
facility: Helsinki University Hospital
city: Reykjavik
country: Iceland
facility: University of Reykjavik, Iceland
city: Trondheim
country: Norway
facility: University Hospital of Trondheim, Norway
city: Gothenburg
country: Sweden
facility: Department of Pediatrics, Drottning Sylvias Pediatric Hospital
Study officials:
affiliation: Oulu University Hospital
name: Arja Harila-Saari, MD
role: PRINCIPAL_INVESTIGATOR
References: