Servier Canada
Asparlas®
ASPARLAS logo; ASPARLAS calaspargase pegol for injection

Study Design

Study AALL07P41

Multicentre, open-label, randomized, active-controlled, parallel-design, clinical pilot study for the treatment of newly-diagnosed patients with high-risk B-precursor ALL aged >1 to < 31 years

ASPARLAS® (N=41)

ASPARLAS® 2500 IU/m2
Intravenously during Induction/Extended Induction, Consolidation, Delayed Intensification and Interim Maintenance phases of an aBFM treatment regimen

Multicentre, open-label, randomized, active-controlled, parallel-design, clinical pilot study for the treatment of newly-diagnosed patients with high-risk B-precursor ALL aged >1 to < 31 years

ONCASPAR® (N=54)

ONCASPAR® 2500 IU/m2
Intravenously during Induction/Extended Induction, Consolidation, Delayed Intensification and Interim Maintenance phases of an aBFM treatment regimen

Adapted from the ASPARLAS® Product Monograph.

Study DFCI 11-0011,10

Multicentre, open-label, randomized, active-controlled clinical study for the treatment of newly-diagnosed patients with ALL or lymphoblastic lymphoma aged 1 to 21 years

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

Multicentre, open-label, randomized, active-controlled clinical study for the treatment of newly-diagnosed patients with ALL or lymphoblastic lymphoma 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

Adapted from the ASPARLAS® Product Monograph and Vrooman et al.

aBFM: augmented Berlin-Frankfurt-Münster; AE: adverse event; ALL: acute lymphoblastic leukemia; ALP: alkaline phosphatase; ALT: alanine aminotransferase; aPTT: activated partial thromboplastin time; AST: aspartate aminotransferase; BFM: Berlin-Frankfurt-Munster; BSA: body surface area; CSF: cerebrospinal fluid; CTCAE: Common Terminology Criteria for Adverse Events; DFCI: Dana-Farber Cancer Institute; IM: intramuscular; IV: intravenous; NCCN: National Comprehensive Cancer Network®; NPAA: nadir plasma arparaginase activity; NSAA: nadir serum asparaginase activity; NSAID: non-steroidal anti-inflammatory drug; PD: pharmacodynamics; PK: pharmacokinetics; TDM: therapeutic drug monitoring.

* Comparative clinical significance has not been established.

† Fictitious cases. May not be representative of all patients.

‡ Clinical significance has not been established.

References: 

  1. ASPARLAS® Product Monograph. Servier Canada.
  2. Data on file. Servier Canada.
  3. ONCASPAR® Product Monograph. Servier Canada.
  4. RYLAZE™ Product Monograph. Jazz Pharmaceuticals Canada Inc.
  5. Government of Canada. Summary Basis of Decision for Asparlas. Available at https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1718207489396.
  6. Government of Canada. ONCASPAR_CPID Redacted.
  7. Terwilliger T, Abdul-Hay M. Acute lymphoblastic leukemia: a comprehensive review and 2017 update. Blood Cancer J. 2017;7(6):e577.
  8. Mank V, Azhar W, Brown K. Leukocytosis. In: StatPearls. Treasure Island (FL): StatPearls Publishing; April 21, 2024.
  9. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology. Acute Lymphoblastic Leukemia, version 4.2023 – February 05, 2024.
  10. 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.
  11. National Institutes of Health. National Cancer Institute. Common Terminology Criteria for Adverse Events (CTCAE): Version 4.0. Available at: https://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03/Archive/CTCAE_4.0_2009-05-29_QuickReference_8.5×11.pdf. Accessed December 11, 2024.
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