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

Phase 3CompletedNCT00819351

Rigshospitalet, Denmark650 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

650

Conditions

Acute Lymphoblastic Leukemia

Interventions

PEG Asparaginase at six weeks intervalDRUG

PEG-asparaginase (1.000 IU/m2/dose) given at six weeks intervals (until the patient has received 33 weeks of therapy)

PEG Asparaginase at two weeks intervalDRUG

PEG-asparaginase (1.000 IU/m2/dose) given at two weeks intervals (until the patient has received 33 weeks of therapy)

Eligibility

Sex: ALLMin age: 1 YearMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (6)

Department of Pediatrics, Rigshospitalet

Copenhagen, Denmark

Helsinki University Hospital

Helsinki, Finland

University Hospital Reykjavik, Iceland

Reykjavik, Iceland

Trondheim University Hospital

Trondheim, Norway

Outcomes

Primary Outcomes

Event Free Survival

Time frame: 6 years

Secondary Outcomes

Secondary Outcome Measures are toxicity (special focus on thrombosis, pancreatitis, and allergic reactions), the formation of silent antibodies, and the influence of antibody production on the EFS.

Time frame: 6 years

Data from ClinicalTrials.gov

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