Phase II, open-label, randomized study in patients 1-9 years.
From the standard treatment arm of CCG-1952 study in patients with standard-risk ALL.
ONCASPAR® (n=58)
ONCASPAR was administered intramuscularly at a dose of 2,500 U/m2 on Day 3 of the 4-week induction phase and on Day 3 of each of two 8-week delayed intensification phases.
Native E. coli
L-asparaginase§ (n=59)
Native E. coli L-asparaginase 6,000 U/m2 IM, 9 injections over 20 days during Induction and 6 injections over 12 days during each of two delayed intensifications
Adapted from the ONCASPAR® Product Monograph.
Multicentre, open-label, randomized, active-controlled clinical trial in the treatment of patients with newly diagnosed ALL aged 1 to 21 years
ONCASPAR® (n=119)
ONCASPAR® 2500 IU/m2 Intravenously during Induction (Day 7), then every 2 weeks starting Week 7 for 30 consecutive weeks (15 doses) as part of a DFCI ALL Consortium backbone therapy
ASPARLAS® (N=118)
ASPARLAS® 2500 IU/m2 Intravenously during Induction (Day 7), then every 3 weeks starting Week 7 for 30 consecutive weeks (10 doses) as part of a DFCI ALL Consortium backbone therapy
Adapted from the ONCASPAR® and ASPARLAS® Product Monographs, and Vrooman et al.
Pilot, open label, controlled, randomized study comparing ASPARLAS® versus ONCASPAR® in the first line treatment of ALL in patients aged 1 to < 31 years
ONCASPAR® (n=54)
ONCASPAR® 2,500 U/m2 Intravenously during Induction/Extended Induction, Consolidation, Delayed Intensification and Interim Maintenance phases of an augmented Berlin-Frankfurt-Münster (aBFM) treatment regimen
ASPARLAS®
Adapted from the ONCASPAR® Product Monograph.
aBFM: augmented Berlin-Frankfurt-Münster; ALL: acute lymphoblastic leukemia; BSA: body surface area; CNS: central nervous system; CSF: cerebrospinal fluid; DFCI: Dana-Farber Cancer Institute; ELISA: enzyme-linked immunosorbent assay; IM: intramuscular; IV: intravenous; PD: pharmacodynamics; PK: pharmacokinetics; NCCN: National Comprehensive Cancer Network®; TDM: therapeutic drug monitoring.
* Clinical significance has not been established.
† Comparative clinical significance has not been established.
‡ Fictitious cases. May not be representative of all patients.
§ Native E. coli L-asparaginase is not available in Canada.
References:
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