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 M. 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 - 2005
Externally publishedYes

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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

  • Cancer Research
  • Oncology

Cite this

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 M.; 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, 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 M. ; 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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T1 - Phase I/II study of galiximab, an anti-CD80 antibody, for relapsed or refractory follicular lymphoma

AU - Czuczman, Myron S.

AU - Thall, Aron

AU - Witzig, Thomas E.

AU - Vose, Julie M.

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.

PY - 2005

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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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