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

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

Status

Suspended

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00991744

Enrollment

100

Registered

2009-10-08

Start date

2009-01-31

Completion date

2018-12-31

Last updated

2012-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Lymphoblastic Leukemia

Keywords

Leukemia, Central nervous system, Neurotoxicity, Liposomal cytarabine, Children, Acute lymphoblastic leukemia, Childhood acute lymphoblastic leukemia, Intrathecal, Efficacy, Safety

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.

Interventions

DRUGLiposomal cytarabine

Intrathecal liposomal cytarabine combined with intrathecal prednisolone and oral dexamethasone during maintenance treatment for high-risk ALL

DRUGIntrathecal 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Years to 18 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Number of leukemia relapses in the central nervous system	5 years

Secondary

Measure	Time frame
Neurological toxicity	6 months after cessation of leukemia therapy

Countries

Denmark, Finland, Iceland, Norway, Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026