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

• Status: Completed
• Trial end date: 2016-03-02
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rigshospitalet, Denmark
• Collaborator: Nordic Society for Pediatric Hematology and Oncology
• Treatments: 6-Mercaptopurine; Asparaginase; Pegaspargase

Criteria

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