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

Phase 3

Completed

• Conditions: Acute Lymphoblastic Leukemia
• Interventions: Drug: PEG Asparaginase at six weeks interval; Drug: PEG Asparaginase at two weeks interval

• Registration Number: NCT00819351
• Lead Sponsor: Rigshospitalet, Denmark

Brief Summary

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

Detailed 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

Study Timeline

• Study Start: 2009-01-01
• Study First Submitted: 2009-01-08
• Study First Submitted QC: 2009-01-08
• Study First Posted: 2009-01-09
• Primary Completion: 2016-03-02
• Study Completion: 2016-03-02
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-20
• Last Update Posted: 2017-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 650

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PEG-asparaginase 6 weeks intervals	PEG Asparaginase at six weeks interval	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.
PEG-Asparaginase 2 weeks intervals	PEG Asparaginase at two weeks interval	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.

Primary Outcome Measures

Name	Time	Method
Event Free Survival	6 years

Secondary Outcome Measures

Name	Time	Method
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.	6 years

Trial Locations

Locations (6)

Department of Pediatrics, Drottning Sylvias Pediatric Hospital; 🇸🇪 Gothenburg, Sweden

University Hospital Reykjavik, Iceland; 🇮🇸 Reykjavik, Iceland

Trondheim University Hospital; 🇳🇴 Trondheim, Norway

Department of Pediatrics, Rigshospitalet; 🇩🇰 Copenhagen, Denmark

NOPHO nordic organisation for pediatric onology; 🇸🇪 Stockholm, Sweden

Helsinki University Hospital; 🇫🇮 Helsinki, Finland