ALL2008 Protocol for Childhood Acute Lymphoblastic Leukemia Intermittent Versus Continuous PEG Asparaginase

Rigshospitalet

Status and phase: Completed; Phase 3

Conditions: Acute Lymphoblastic Leukemia

Treatments: Drug: PEG Asparaginase at six weeks interval; Drug: PEG Asparaginase at two weeks interval

Study type: Interventional

Funder types: Other

Identifiers

NCT00819351

NOPHO ALL2008 PEG Asparaginase

Details and patient eligibility

About

The purpose of this study is to investigate if intramuscular PEG-asparaginase administered either at six or two week intervals from day 92 until 8 months from diagnosis for patients with non-HR ALL will result in equal probability of Event Free Survival

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:

To test if intramuscular PEG-asparaginase administered either at six or two week intervals from day 92 until 8 months from diagnosis for patients with non-HR ALL will result in equal probability of EFS. As secondary endpoints asparaginase antibody production and toxicity including allergic reactions in the treatment-arms will be analysed

Enrollment: 650 patients

Sex: All

Ages: 1 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Childhood ALL
• All mandatory biological data are available6
• Written informed consent has been obtained

Exclusion criteria

• Bilineage ALL
• Pre-treatment with glucocorticosteroids or other antileukemic agents for more than 1 week
• ALL predisposition syndromes
• Previous cancer
• Off protocol administration of additional chemotherapy during induction therapy
• Sexually active females not using contraception
• No allergic reactions to PEG Asparaginase

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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650 participants in 2 patient groups

PEG-asparaginase 6 weeks intervals

Experimental group

Description:

PEG-asparaginase (1.000 IU/m2/dose) given at six weeks intervals (from week 13 after diagnosis to week 33). All additional therapy (High Dose Methotrexate, Vincristin, Dexamethasone, 6-Mercaptopurine, doxorubicin, intrathecal chemotherapy) is the same in both arms.

Treatment:

Drug: PEG Asparaginase at six weeks interval

PEG-Asparaginase 2 weeks intervals

Active Comparator group

Description:

PEG-asparaginase (1.000 IU/m2/dose) given at two weeks intervals (from week 13 after diagnosis to week 33). All additional therapy (High Dose Methotrexate, Vincristin, Dexamethasone, 6-Mercaptopurine, doxorubicin, intrathecal chemotherapy) is the same in both arms.

Treatment:

Drug: PEG Asparaginase at two weeks interval