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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


Phase 3
1 Year
18 Years
Not Enrolling
Both
Acute Lymphoblastic Leukemia

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Number of leukemia relapses in the central nervous system

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

Arja Harila-Saari, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Oulu University Hospital

Authority:

Denmark: Danish Medicines Agency

Study ID:

NOPHOALL2008-DepoCyte

NCT ID:

NCT00991744

Start Date:

January 2009

Completion Date:

December 2018

Related Keywords:

  • Acute Lymphoblastic Leukemia
  • Leukemia
  • Central nervous system
  • Neurotoxicity
  • Liposomal cytarabine
  • Children
  • Acute lymphoblastic leukemia
  • Childhood acute lymphoblastic leukemia
  • Intrathecal
  • Efficacy
  • Safety
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma

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