Trial intelligence / Profile preview

PEG-asparaginase intervals in acute lymphoblastic leukemia

NCT00819351Phase 3

Key facts

Status
Completed
Start
Jan 2009
Primary completion
Mar 2016
Countries
5
Sponsor
Rigshospitalet
Modality
Therapeutic Enzymes
Conditions
acute lymphoblastic leukemia (ALL)
01

Overview

Phase 3, randomised, open-label trial of pegaspargase in acute lymphoblastic leukemia (ALL), sponsored by Rigshospitalet. Started Jan 2009; status: completed.

02

Design

Study design
RandomizedOpen-label
03

Who it enrols

Children and young adults with newly diagnosed acute lymphoblastic leukemia, excluding those with bilineage ALL or significant pre-treatment.

04

Registry description

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

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