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, Inge Appel, Hans Juergen Kuehnel, Iris Tetzlaff-Fohr, Uwe Pichlmeier, Inekee Van Der Vaart, Eline Visser, Rolinda Stigter

Onderzoeksoutput: Bijdrage aan tijdschriftArtikelpeer review

14 Citaten (Scopus)

Samenvatting

The pharmacokinetics, pharmacodynam-ics, efficacy, and safety of a new recom-binant Escherichia coli - asparaginase preparation was compared withAsparagi-nase medac. Thirty-two children with acute lymphoblastic leukemia were randomized to receive one of both agents at a dose of 5000 U/m2 every 3 days, for a total of 8 doses during induction treatment. The serum activity-time profile after the first dose of recombinant asparagi-nase 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 aspar-agine 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 pharma-codynamic effects and the same direct toxicity profile in children with acute lym-phoblastic leukemia. This trial was registered at http://www. controlled-trials.com as no. ISRCTN 75734403.

Originele taal-2Engels
Pagina's (van-tot)4832-4838
Aantal pagina's7
TijdschriftBlood
Volume112
Nummer van het tijdschrift13
DOI's
StatusGepubliceerd - 15 dec. 2008
Extern gepubliceerdJa

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