Phase I/II study of galiximab, an anti-CD80 antibody, for relapsed or refractory follicular lymphoma.

Journal Article (Clinical Trial;Journal Article;Multicenter Study)

PURPOSE: This multicenter, dose-escalation study evaluates the safety, pharmacokinetics, and efficacy of galiximab (anti-CD80 monoclonal antibody) in patients with relapsed or refractory follicular lymphoma. PATIENTS AND METHODS: Patients had follicular lymphoma that had relapsed or failed to respond to primary therapy; the majority (90%) presented with stage III or IV disease. Four weekly intravenous infusions of galiximab were administered at doses of 125, 250, 375, or 500 mg/m2. RESULTS: Thirty-seven patients received galiximab treatment and were evaluated for safety; 35 were assessable for response. Antibody infusions were safe and well tolerated with no dose-limiting toxicities. A total of 22 (60%) of 37 patients experienced adverse events related to galiximab. All but one of the events were grade 1 or 2; the most common were fatigue, nausea, and headache. Cytopenias were rare; only one patient experienced anemia and febrile neutropenia, which were unrelated to galiximab and resolved after treatment. No patient developed antigaliximab antibody formation. The mean serum half-life ranged from 13 to 24 days. The overall response rate was 11% (two complete responses and two partial responses). Time to best response was delayed (months 3, 6, 9, and 12). Twelve patients (34%) maintained stable disease. Nearly half of all patients (49%) had a decrease in indicator lesions. Two responders remain on study without progression (22 and 24.4 months). CONCLUSION: The favorable safety profile of galiximab and evidence of single-agent biologic activity and dose-dependent pharmacokinetics support further evaluation of galiximab as a treatment for follicular lymphoma, possibly in combination with other lymphoma therapies.

Full Text

Duke Authors

Cited Authors

  • Czuczman, MS; Thall, A; Witzig, TE; Vose, JM; Younes, A; Emmanouilides, C; Miller, TP; Moore, JO; Leonard, JP; Gordon, LI; Sweetenham, J; Alkuzweny, B; Finucane, DM; Leigh, BR

Published Date

  • July 1, 2005

Published In

Volume / Issue

  • 23 / 19

Start / End Page

  • 4390 - 4398

PubMed ID

  • 15994148

International Standard Serial Number (ISSN)

  • 0732-183X

Digital Object Identifier (DOI)

  • 10.1200/JCO.2005.09.018

Language

  • eng

Conference Location

  • United States