Resumo

FAXAS GARCIA, María E.; GUERRA YI, Marta E.; ALVAREZ, Alejandro  e  CALDERON, Carlos. Ensayo clínico fase I del anticuerpo monoclonal IOR-T1 en linfoma T: farmacocinética y respuesta inmune. Rev cubana med [online]. 2003, vol.42, n.2, pp. 140-142. ISSN 1561-302X.

As part of the stage I clinical trial with the murine monoclonal antibody IOR-T1 at repeated doses (200-800 mg) in patients carriers of cutaneous T-cell lymphoma, the pharmacokinetics and the response against the mouse protein (HAMA) were studied in the 10 patients under treatment. It was observed a great individual variation in the maximum concentration in serum, which was estimated at 2 hours. The mean life time of the monoclonal antibody was between 13.93 and 19.6 hours. Most of the patients developed antibodies against the monoclonal antibody IOR-T1. The presence of this second antibody did not alter signficantly the pharmacokinetics of the administered monoclonal antibody.

Palavras-chave : CLINICAL TRIALS, PHASE I [methods]; LYMPHOMA, T-CELL, CUTANEOUS [drug therapy]; ANTIBODIES, MONOCLONAL [pharmacokinetics].

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