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

Myron S. Czuczman, Aron Thall, Thomas E. Witzig, Julie Marie Vose, Anas Younes, Christos Emmanouilides, Thomas P. Miller, Joseph O. Moore, John P. Leonard, Leo I. Gordon, John Sweetenham, Baha Alkuzweny, Deborah M. Finucane, Bryan R. Leigh

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Abstract

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.

Original languageEnglish (US)
Pages (from-to)4390-4398
Number of pages9
JournalJournal of Clinical Oncology
Volume23
Issue number19
DOIs
StatePublished - Dec 1 2005

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Follicular Lymphoma
Anti-Idiotypic Antibodies
Safety
Pharmacokinetics
Therapeutics
galiximab
Febrile Neutropenia
Biological Factors
Intravenous Infusions
Nausea
Antibody Formation
Fatigue
Headache
Half-Life
Anemia
Lymphoma
Monoclonal Antibodies
Antibodies

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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Czuczman, M. S., Thall, A., Witzig, T. E., Vose, J. M., Younes, A., Emmanouilides, C., ... Leigh, B. R. (2005). Phase I/II study of galiximab, an anti-CD80 antibody, for relapsed or refractory follicular lymphoma. Journal of Clinical Oncology, 23(19), 4390-4398. https://doi.org/10.1200/JCO.2005.09.018

Phase I/II study of galiximab, an anti-CD80 antibody, for relapsed or refractory follicular lymphoma. / Czuczman, Myron S.; Thall, Aron; Witzig, Thomas E.; Vose, Julie Marie; Younes, Anas; Emmanouilides, Christos; Miller, Thomas P.; Moore, Joseph O.; Leonard, John P.; Gordon, Leo I.; Sweetenham, John; Alkuzweny, Baha; Finucane, Deborah M.; Leigh, Bryan R.

In: Journal of Clinical Oncology, Vol. 23, No. 19, 01.12.2005, p. 4390-4398.

Research output: Contribution to journalArticle

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 2005, 'Phase I/II study of galiximab, an anti-CD80 antibody, for relapsed or refractory follicular lymphoma', Journal of Clinical Oncology, vol. 23, no. 19, pp. 4390-4398. https://doi.org/10.1200/JCO.2005.09.018
Czuczman, Myron S. ; Thall, Aron ; Witzig, Thomas E. ; Vose, Julie Marie ; Younes, Anas ; Emmanouilides, Christos ; Miller, Thomas P. ; Moore, Joseph O. ; Leonard, John P. ; Gordon, Leo I. ; Sweetenham, John ; Alkuzweny, Baha ; Finucane, Deborah M. ; Leigh, Bryan R. / Phase I/II study of galiximab, an anti-CD80 antibody, for relapsed or refractory follicular lymphoma. In: Journal of Clinical Oncology. 2005 ; Vol. 23, No. 19. pp. 4390-4398.
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abstract = "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.",
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AU - Thall, Aron

AU - Witzig, Thomas E.

AU - Vose, Julie Marie

AU - Younes, Anas

AU - Emmanouilides, Christos

AU - Miller, Thomas P.

AU - Moore, Joseph O.

AU - Leonard, John P.

AU - Gordon, Leo I.

AU - Sweetenham, John

AU - Alkuzweny, Baha

AU - Finucane, Deborah M.

AU - Leigh, Bryan R.

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N2 - 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.

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