Study Design
Study CCG-19621
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.
Study DFCI 11-0011,6
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.
Study AALL07P41
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:
- ONCASPAR® Product Monograph. Servier Canada. August 20, 2024.
- ONCASPAR_CPID Redacted.
- ASPARLAS® Product Monograph. Servier Canada. March 8, 2024.
- RYLAZE™ Product Monograph. Jazz Pharmaceuticals Canada Inc.
- NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Acute Lymphoblastic Leukemia V.2.2024. Available at: https://www.nccn.org/professionals/physician_gls/pdf/all.pdf. Accessed November 8, 2024.
- Vrooman LM et al. Efficacy and toxicity of pegaspargase and calaspargase pegol in childhood acute lymphoblastic leukemia: Results of DFCI 11-001. J Clin Oncol. 2021;39(31):3496–3505.
