Se trata de un estudio de seguridad a largo plazo, multicéntrico, de etiqueta abierta de mepolizumab 100 miligramos (mg) administrado por vía subcutánea (SC) además del tratamiento estándar en sujetos que participaron en el estudio MEA112997. En cada visita clínica se evaluarán los eventos adversos y también se revisarán las exacerbaciones.
Protocol BO21004 is divided into 3 separate Unique Protocol IDs for reporting results on clinicaltrials.gov because there are 3 separate primary analyses conducted at different time-points. * BO21004 (Stage 1a) \[NCT01010061\] includes the analysis of 2 of the 3 arms obinutuzumab plus chlorambucil (Glb) compared to chlorambucil (Clb) reported separately. * BO21004 (Stage 1b) \[NCT01998880\] includes the analysis of 2 of the 3 arms rituximab plus chlorambucil (RClb) compared to chlorambucil (Clb) reported separately. * BO21004 (Stage 2) includes the analysis of 2 of the 3 arms obinutuzumab plus chlorambucil (Glb) compared to rituximab plus chlorambucil (RClb) reported here.
1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 \[first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment\], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles).
375 mg/m\^2 rituximab intravenous (IV) infusion on Day 1 of Cycle 1 (Cycle duration is 28 days) then 500 mg/m\^2 IV infusions on Day 1 of Cycles 2-6.
Chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle
Buenos Aires, Argentina
Buenos Aires, Argentina
Buenos Aires, Argentina
Buenos Aires, Argentina
Buenos Aires, Argentina
Buenos Aires, Argentina
Rosario, Argentina