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.
© 2013 John Wiley & Sons Ltd.
Publication types
-
Clinical Trial
-
Multicenter Study
-
Research Support, N.I.H., Extramural
-
Research Support, Non-U.S. Gov't
MeSH terms
-
Adolescent
-
Adult
-
Age Factors
-
Antibodies, Monoclonal, Murine-Derived / administration & dosage
-
Antibodies, Monoclonal, Murine-Derived / blood*
-
Antineoplastic Agents / administration & dosage
-
Antineoplastic Agents / blood*
-
Antineoplastic Combined Chemotherapy Protocols / therapeutic use
-
Cyclophosphamide / therapeutic use
-
Doxorubicin / therapeutic use
-
Drug Administration Schedule
-
Half-Life
-
Humans
-
L-Lactate Dehydrogenase / blood
-
Lymphoma, B-Cell / blood*
-
Lymphoma, B-Cell / drug therapy
-
Lymphoma, B-Cell / pathology
-
Methotrexate / therapeutic use
-
Neoplasm Staging
-
Pilot Projects
-
Prednisone / therapeutic use
-
Rituximab
-
Vincristine / therapeutic use
-
Young Adult
Substances
-
Antibodies, Monoclonal, Murine-Derived
-
Antineoplastic Agents
-
Rituximab
-
Vincristine
-
Doxorubicin
-
Cyclophosphamide
-
L-Lactate Dehydrogenase
-
Prednisone
-
Methotrexate