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

Nordic Society for Pediatric Hematology and Oncology

Status and phase: Suspended; Phase 3

Conditions: Acute Lymphoblastic Leukemia

Treatments: Drug: Liposomal cytarabine; Drug: Intrathecal triple

Study type: Interventional

Funder types: Other

Identifiers

NCT00991744

NOPHOALL2008-DepoCyte

Details and patient eligibility

About

• 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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 1 to 18 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 2 patient groups

Liposomal cytarabine

Experimental group

Description:

Intrathecal liposomal cytarabine (25 - 50 mg) combined with intrathecal prednisolone sodium succinate and oral dexamethasone 6 times during maintenance treatment for high-risk ALL

Treatment:

Drug: Liposomal cytarabine

Intrathecal triple

Active Comparator group

Description:

Intrathecal methotrexate, cytarabine and prednisolone

Treatment:

Drug: Intrathecal triple