Pharmacokinetics, pharmacodynamics, efficacy, and safety of a new recombinant asparaginase preparation in children with previously untreated acute lymphoblastic leukemia: a randomized phase 2 clinical trial - PubMed (original) (raw)
Clinical Trial
. 2008 Dec 15;112(13):4832-8.
doi: 10.1182/blood-2008-04-149443. Epub 2008 Sep 19.
Affiliations
- PMID: 18805963
- DOI: 10.1182/blood-2008-04-149443
Free article
Clinical Trial
Pharmacokinetics, pharmacodynamics, efficacy, and safety of a new recombinant asparaginase preparation in children with previously untreated acute lymphoblastic leukemia: a randomized phase 2 clinical trial
Rob Pieters et al. Blood. 2008.
Free article
Abstract
The pharmacokinetics, pharmacodynamics, efficacy, and safety of a new recombinant Escherichia coli-asparaginase preparation was compared with Asparaginase medac. Thirty-two children with acute lymphoblastic leukemia were randomized to receive one of both agents at a dose of 5000 U/m(2) every 3 days, for a total of 8 doses during induction treatment. The serum activity-time profile after the first dose of recombinant asparaginase was similar to that of Asparaginase medac. The trough serum activities were greater than the desired threshold of 100 U/L in both treatment groups. Asparagine was completely depleted in serum and in cerebrospinal fluid, whereas glutamine levels were only moderately influenced. No significant difference between the 2 treatments regarding the degree of asparagine depletion, duration of depletion, complete remission rate, and minimal residual disease status at the end of induction, overall frequency or intensity of adverse events was seen. Observed adverse reactions are known as possible and labeled side effects of asparaginase treatment and chemotherapy. We conclude that the new recombinant asparaginase and other native Asparaginase medac are bioequivalent and have the same pharmacodynamic effects and the same direct toxicity profile in children with acute lymphoblastic leukemia. This trial was registered at http://www.controlled-trials.com as no. ISRCTN 75734403.
Similar articles
- Efficacy and safety of recombinant E. coli asparaginase in children with previously untreated acute lymphoblastic leukemia: A randomized multicenter study of the Dutch Childhood Oncology Group.
van der Sluis IM, de Groot-Kruseman H, Te Loo M, Tissing WJE, van den Bos C, Kaspers GJL, Bierings M, Kollen WJW, König T, Pichlmeier U, Kühnel HJ, Pieters R. van der Sluis IM, et al. Pediatr Blood Cancer. 2018 Aug;65(8):e27083. doi: 10.1002/pbc.27083. Epub 2018 May 4. Pediatr Blood Cancer. 2018. PMID: 29727043 Clinical Trial. - Pediatric Acute Lymphoblastic Leukemia: Efficacy and safety of recombinant E. coli-asparaginase in infants (less than one year of age) with acute lymphoblastic leukemia.
van der Sluis I, Möricke A, Escherich G, von Stackelberg A, Holter W, Klingebiel T, Flotho C, Legien S, Tissing W, Bierings M, Guimbal-Schmolck C, Pichlmeier U, Kühnel HJ, Pieters R. van der Sluis I, et al. Haematologica. 2013 Nov;98(11):1697-701. doi: 10.3324/haematol.2013.090563. Epub 2013 Jun 10. Haematologica. 2013. PMID: 23753025 Free PMC article. Clinical Trial. - FDA drug approval summary: pegaspargase (oncaspar) for the first-line treatment of children with acute lymphoblastic leukemia (ALL).
Dinndorf PA, Gootenberg J, Cohen MH, Keegan P, Pazdur R. Dinndorf PA, et al. Oncologist. 2007 Aug;12(8):991-8. doi: 10.1634/theoncologist.12-8-991. Oncologist. 2007. PMID: 17766659 Clinical Trial. - Use of L-asparaginase in childhood ALL.
Müller HJ, Boos J. Müller HJ, et al. Crit Rev Oncol Hematol. 1998 Aug;28(2):97-113. doi: 10.1016/s1040-8428(98)00015-8. Crit Rev Oncol Hematol. 1998. PMID: 9768345 Review. - Asparaginase pharmacokinetics and implications of therapeutic drug monitoring.
Asselin B, Rizzari C. Asselin B, et al. Leuk Lymphoma. 2015;56(8):2273-80. doi: 10.3109/10428194.2014.1003056. Epub 2015 Mar 11. Leuk Lymphoma. 2015. PMID: 25586605 Free PMC article. Review.
Cited by
- Development of Escherichia coli Asparaginase II for Immunosensing: A Trade-Off between Receptor Density and Sensing Efficiency.
Charbonneau DM, Aubé A, Rachel NM, Guerrero V, Delorme K, Breault-Turcot J, Masson JF, Pelletier JN. Charbonneau DM, et al. ACS Omega. 2017 May 31;2(5):2114-2125. doi: 10.1021/acsomega.7b00110. Epub 2017 May 17. ACS Omega. 2017. PMID: 30023654 Free PMC article. - Expression levels of ASNS in mesenchymal stromal cells in childhood acute lymphoblastic leukemia.
Dimitriou H, Choulaki C, Perdikogianni C, Stiakaki E, Kalmanti M. Dimitriou H, et al. Int J Hematol. 2014 Mar;99(3):305-10. doi: 10.1007/s12185-014-1509-y. Epub 2014 Jan 29. Int J Hematol. 2014. PMID: 24474640 - Pharmacokinetic modeling of an induction regimen for in vivo combined testing of novel drugs against pediatric acute lymphoblastic leukemia xenografts.
Szymanska B, Wilczynska-Kalak U, Kang MH, Liem NL, Carol H, Boehm I, Groepper D, Reynolds CP, Stewart CF, Lock RB. Szymanska B, et al. PLoS One. 2012;7(3):e33894. doi: 10.1371/journal.pone.0033894. Epub 2012 Mar 29. PLoS One. 2012. PMID: 22479469 Free PMC article. - Metabolic Reprogramming of Thyroid Cancer Cells and Crosstalk in Their Microenvironment.
Bao L, Xu T, Lu X, Huang P, Pan Z, Ge M. Bao L, et al. Front Oncol. 2021 Dec 2;11:773028. doi: 10.3389/fonc.2021.773028. eCollection 2021. Front Oncol. 2021. PMID: 34926283 Free PMC article. Review. - A clinically attainable dose of L-asparaginase targets glutamine addiction in lymphoid cell lines.
Sugimoto K, Suzuki HI, Fujimura T, Ono A, Kaga N, Isobe Y, Sasaki M, Taka H, Miyazono K, Komatsu N. Sugimoto K, et al. Cancer Sci. 2015 Nov;106(11):1534-43. doi: 10.1111/cas.12807. Epub 2015 Oct 16. Cancer Sci. 2015. PMID: 26331698 Free PMC article.
Publication types
MeSH terms
Substances
LinkOut - more resources
Full Text Sources
Other Literature Sources