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

Acute Lymphoblastic Leukemia Clinical Trial

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00991744
• Other study ID #: NOPHOALL2008-DepoCyte
• Status: Suspended
• Phase: Phase 3
• First received: October 7, 2009
• Last updated: October 6, 2012
• Start date: January 2009
• Est. completion date: December 2018

Study information

• Verified date: October 2012
• Source: Nordic Society for Pediatric Hematology and Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines AgencyDenmark: The Danish National Committee on Biomedical Research EthicsFinland: National Advisory Board on Health Care EthicsFinland: Finnish Medicines AgencyIceland: Icelandic Medicines Control AgencyNorway: Norwegian Medicines AgencyNorway:National Committee for Medical and Health Research EthicsSweden: Swedish National Council on Medical EthicsSweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 100
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 18 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

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

Locations

Country	Name	City	State
Denmark	Department of Pediatrics, Rigshospitalet	Copenhagen
Finland	Helsinki University Hospital	Helsinki
Iceland	University of Reykjavik, Iceland	Reykjavik
Norway	University Hospital of Trondheim, Norway	Trondheim
Sweden	Department of Pediatrics, Drottning Sylvias Pediatric Hospital	Gothenburg

Sponsors (2)

Lead Sponsor	Collaborator
Nordic Society for Pediatric Hematology and Oncology	Oulu University Hospital

Countries where clinical trial is conducted

Denmark,  Finland,  Iceland,  Norway,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of leukemia relapses in the central nervous system		5 years	No
Secondary	Neurological toxicity		6 months after cessation of leukemia therapy	Yes