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Clinical Trial
. 2013 Sep;162(5):678-83.
doi: 10.1111/bjh.12434. Epub 2013 Jun 27.

Rituximab pharmacokinetics in children and adolescents with de novo intermediate and advanced mature B-cell lymphoma/leukaemia: a Children's Oncology Group report

Matthew J Barth  1 , Stanton Goldman, Lynette Smith, Sherrie Perkins, Bruce Shiramizu, Thomas G Gross, Lauren Harrison, Warren Sanger, Mark B Geyer, Lisa Giulino-Roth, Mitchell S Cairo
Affiliations
Clinical Trial

Rituximab pharmacokinetics in children and adolescents with de novo intermediate and advanced mature B-cell lymphoma/leukaemia: a Children's Oncology Group report

Matthew J Barth et al. Br J Haematol. 2013 Sep.

Abstract

The ANHL01P1 trial was undertaken to determine pharmacokinetics and safety following the addition of rituximab to French-American-British/Lymphome Malins de Burkitt (FAB/LMB96) chemotherapy in 41 children and adolescents with Stage III/IV mature B-cell lymphoma/leukaemia. Patients received rituximab (375 mg/m(2) ) days -2 and 0 of two induction cycles and day 0 of two consolidation cycles. Highest peak levels were achieved following the second dose of each induction cycle [299 ± 19 and 384 ± 25 μg/ml (Group-B); 245 ± 31 and 321 ± 32 μg/ml (Group-C)] with sustained troughs and t½ of 26-29 d. Rituximab can be safely added to FAB chemotherapy with high early rituximab peak/trough levels and a long t½.

Keywords: CD20; non-Hodgkin lymphoma; pediatric; pharmacokinetics; rituximab.

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Conflict of interest statement

All other authors declare no conflict of interest.

Figures

Figure 1
Figure 1. Serum rituximab concentrations in patients receiving chemoimmunotherapy
(A) Graphical representation of mean ± standard error of the mean (SEM) serum rituximab concentration during induction cycles 1 (COPADM1) and 2 (COPADM2) in Group-B and Group-C patients. (B) Graphical representation of mean ± SEM serum rituximab concentrations from the last administered rituximab dose in Group-B and Group-C patients. COPADM: cyclophosphamide, vincristine, prednisone, adriamycin and methotrexate
Figure 1
Figure 1. Serum rituximab concentrations in patients receiving chemoimmunotherapy
(A) Graphical representation of mean ± standard error of the mean (SEM) serum rituximab concentration during induction cycles 1 (COPADM1) and 2 (COPADM2) in Group-B and Group-C patients. (B) Graphical representation of mean ± SEM serum rituximab concentrations from the last administered rituximab dose in Group-B and Group-C patients. COPADM: cyclophosphamide, vincristine, prednisone, adriamycin and methotrexate
Figure 2
Figure 2. Variability in serum rituximab concentrations based on patient age and lactate dehydrogenase
(A) Graphical representation of mean ± standard error of the mean (SEM) serum rituximab concentration during induction cycles 1 (COPADM1) and 2 (COPADM2) with patients stratified by lactate dehydrogenase (LDH) < or ≥2 × upper limit of normal (ULN). (B) Graphical representation of mean ± SEM serum rituximab concentration during induction cycles 1 (COPADM1) and 2 (COPADM2) with patients stratified by age < vs. ≥13 years.
Figure 2
Figure 2. Variability in serum rituximab concentrations based on patient age and lactate dehydrogenase
(A) Graphical representation of mean ± standard error of the mean (SEM) serum rituximab concentration during induction cycles 1 (COPADM1) and 2 (COPADM2) with patients stratified by lactate dehydrogenase (LDH) < or ≥2 × upper limit of normal (ULN). (B) Graphical representation of mean ± SEM serum rituximab concentration during induction cycles 1 (COPADM1) and 2 (COPADM2) with patients stratified by age < vs. ≥13 years.
See this image and copyright information in PMC

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