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

Phase 3

Suspended

• Conditions: Acute Lymphoblastic Leukemia
• Interventions: Drug: Liposomal cytarabine; Drug: Intrathecal triple

• Registration Number: NCT00991744
• Lead Sponsor: Nordic Society for Pediatric Hematology and Oncology

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.

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-10-07
• Study First Submitted QC: 2009-10-07
• Study First Posted: 2009-10-08
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-06
• Last Update Posted: 2012-10-10
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Liposomal cytarabine	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
Intrathecal triple	Intrathecal triple	Intrathecal methotrexate, cytarabine and prednisolone

Primary Outcome Measures

Name	Time	Method
Number of leukemia relapses in the central nervous system	5 years

Secondary Outcome Measures

Name	Time	Method
Neurological toxicity	6 months after cessation of leukemia therapy

Trial Locations

Locations (5)

Department of Pediatrics, Drottning Sylvias Pediatric Hospital; 🇸🇪 Gothenburg, Sweden

Department of Pediatrics, Rigshospitalet; 🇩🇰 Copenhagen, Denmark

University of Reykjavik, Iceland; 🇮🇸 Reykjavik, Iceland

University Hospital of Trondheim, Norway; 🇳🇴 Trondheim, Norway

Helsinki University Hospital; 🇫🇮 Helsinki, Finland