Skip to main content
release_alert
Welcome to the new Scholars 3.0! Read about new features and let us know what you think.
cancel
Journal cover image

A phase I/II study of galiximab (an anti-CD80 monoclonal antibody) in combination with rituximab for relapsed or refractory, follicular lymphoma.

Publication ,  Journal Article
Leonard, JP; Friedberg, JW; Younes, A; Fisher, D; Gordon, LI; Moore, J; Czuczman, M; Miller, T; Stiff, P; Cheson, BD; Forero-Torres, A ...
Published in: Ann Oncol
July 2007

BACKGROUND: Galiximab is a monoclonal antibody that targets CD80, a costimulatory molecule constitutively expressed on follicular and other lymphomas. Modest single-agent clinical activity and tolerability were demonstrated in a phase I study in relapsed or refractory, follicular non-Hodgkin's lymphoma (NHL). A phase I/II study was conducted to evaluate galiximab in combination with a standard course of rituximab. Safety, pharmacokinetics, and efficacy were evaluated. PATIENTS AND METHODS: Patients with follicular NHL who had relapsed or failed primary therapy were enrolled. Rituximab-refractory patients (no response or a response with time to progression <6 months) were excluded. Patients received 4 weekly i.v. infusions of galiximab (125, 250, 375, or 500 mg/m(2)) and rituximab (375 mg/m(2)). International Workshop Response Criteria (IWRC) were used to evaluate response. RESULTS: Seventy-three patients received treatment. All had received at least one prior lymphoma therapy; 40% were rituximab naive. Infusions were delivered in an outpatient setting and were well tolerated. The most common study-related adverse events (AE) were lymphopenia, leukopenia, neutropenia, fatigue, and chills. The overall response rate at the recommended phase II dose of galiximab (500 mg/m(2)) was 66%: 19% complete response, 14% unconfirmed complete response, and 33% partial response. The median progression free survival was 12.1 months. Combination therapy did not appear to alter pharmacokinetics. CONCLUSION: These results indicate that galiximab can be safely combined with a standard course of rituximab. This doublet biologic approach offers the potential to avoid or delay chemotherapy or to integrate with other lymphoma therapies. A phase III, randomized study evaluating clinical benefit of rituximab versus the combination has been initiated.

Duke Scholars

Altmetric Attention Stats
Dimensions Citation Stats

Published In

Ann Oncol

DOI

ISSN

0923-7534

Publication Date

July 2007

Volume

18

Issue

7

Start / End Page

1216 / 1223

Location

England

Related Subject Headings

  • Rituximab
  • Oncology & Carcinogenesis
  • Neoplasm Recurrence, Local
  • Middle Aged
  • Lymphoma, Follicular
  • Humans
  • Drug Resistance, Neoplasm
  • Antineoplastic Combined Chemotherapy Protocols
  • Antibodies, Monoclonal, Murine-Derived
  • Antibodies, Monoclonal
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Leonard, J. P., Friedberg, J. W., Younes, A., Fisher, D., Gordon, L. I., Moore, J., … Molina, A. (2007). A phase I/II study of galiximab (an anti-CD80 monoclonal antibody) in combination with rituximab for relapsed or refractory, follicular lymphoma. Ann Oncol, 18(7), 1216–1223. https://doi.org/10.1093/annonc/mdm114
Leonard, J. P., J. W. Friedberg, A. Younes, D. Fisher, L. I. Gordon, J. Moore, M. Czuczman, et al. “A phase I/II study of galiximab (an anti-CD80 monoclonal antibody) in combination with rituximab for relapsed or refractory, follicular lymphoma.Ann Oncol 18, no. 7 (July 2007): 1216–23. https://doi.org/10.1093/annonc/mdm114.
Leonard JP, Friedberg JW, Younes A, Fisher D, Gordon LI, Moore J, et al. A phase I/II study of galiximab (an anti-CD80 monoclonal antibody) in combination with rituximab for relapsed or refractory, follicular lymphoma. Ann Oncol. 2007 Jul;18(7):1216–23.
Leonard, J. P., et al. “A phase I/II study of galiximab (an anti-CD80 monoclonal antibody) in combination with rituximab for relapsed or refractory, follicular lymphoma.Ann Oncol, vol. 18, no. 7, July 2007, pp. 1216–23. Pubmed, doi:10.1093/annonc/mdm114.
Leonard JP, Friedberg JW, Younes A, Fisher D, Gordon LI, Moore J, Czuczman M, Miller T, Stiff P, Cheson BD, Forero-Torres A, Chieffo N, McKinney B, Finucane D, Molina A. A phase I/II study of galiximab (an anti-CD80 monoclonal antibody) in combination with rituximab for relapsed or refractory, follicular lymphoma. Ann Oncol. 2007 Jul;18(7):1216–1223.
Journal cover image

Published In

Ann Oncol

DOI

ISSN

0923-7534

Publication Date

July 2007

Volume

18

Issue

7

Start / End Page

1216 / 1223

Location

England

Related Subject Headings

  • Rituximab
  • Oncology & Carcinogenesis
  • Neoplasm Recurrence, Local
  • Middle Aged
  • Lymphoma, Follicular
  • Humans
  • Drug Resistance, Neoplasm
  • Antineoplastic Combined Chemotherapy Protocols
  • Antibodies, Monoclonal, Murine-Derived
  • Antibodies, Monoclonal