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[PDF][PDF] IDEC-C2B8: results of a phase I multiple-dose trial in patients with relapsed non-Hodgkin's lymphoma.

DG Maloney, AJ Grillo-López, DJ Bodkin… - Journal of clinical …, 1997 - io.ctdm.org.cn
DG Maloney, AJ Grillo-López, DJ Bodkin, CA White, TM Liles, I Royston, C Varns…
Journal of clinical oncology, 1997•io.ctdm.org.cn
Purpose: To evaluate the safety, pharmacokinetics, andbiologic effect of multiple doses of
the chimeric anti-CD20 monoclonal antibody (mAb) IDEC-C2B8 in patients with relapsed B-
cell lymphoma. Patients andMethods: Twenty patients with relapsed low-grade (n= 15) or
intermediate-/high-grade (n= 5) lymphoma received weekly infusions times four of 125 mg/m
2 (n= 3), 250 mg/m 2 (n= 7), or 375 mg/m 2(n= 10) of IDEC-C2B8. Results: Infusional side
effects during the initial infu-sion were mainly grade/11 fever, asthenia, chills, nausea, rash …
Purpose: To evaluate the safety, pharmacokinetics, andbiologic effect of multiple doses of the chimeric anti-CD20 monoclonal antibody (mAb) IDEC-C2B8 in patients with relapsed B-cell lymphoma.
Patients andMethods: Twenty patients with relapsed low-grade (n= 15) or intermediate-/high-grade (n= 5) lymphoma received weekly infusions times four of 125 mg/m 2 (n= 3), 250 mg/m 2 (n= 7), or 375 mg/m 2(n= 10) of IDEC-C2B8.
Results: Infusional side effects during the initial infu-sion were mainly grade/11 fever, asthenia, chills, nausea, rash, and urticaria. More serious events were rare. Peripheral-blood B cells were rapidly depleted and slowly recovered over 3 to 6 months. There was no change in mean immunoglobulin (Ig) levels. Antibody serum half-life (and maximum concentration [Cm.,]) generally increased between the first and fourth infusions (33.2 hours v 76.6 hours, respectively) following the
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