A phase III study of anti-B4-blocked ricin as adjuvant therapy post-autologous bone marrow transplant: CALGB 9254

Richard R. Furman, Michael L. Grossbard, Jeffrey L. Johnson, Andrew L. Pecora, Peter A. Cassileth, Sin Ho Jung, Bruce A. Peterson, Lee M. Nadler, Arnold Freedman, Ruthee Lu Bayer, Nancy L. Bartlett, David D. Hurd, Bruce D. Cheson

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18 Scopus citations

Abstract

Anti-B4-blocked ricin (anti-B4-bR) is a potent immunotoxin directed against the CD19 antigen. Previous phase I and II studies suggested a possible role for anti-B4-bR as consolidation after high-dose chemotherapy and autologous stem cell transplant. Cancer and Leukemia Group B (CALGB) 9254 is a phase III study which randomized 157 patients with B-cell lymphoma in complete remission following autologous transplant to treatment with anti-B4-bR or observation. With a median follow-up time for patients of 5.8 years, the median event-free survival for protocol treatment and observation are 2.1 and 2.9 years, respectively (p = 0.275). The median overall survival for treatment and observation are 6.1 years and not reached, respectively (p = 0.063). Therefore, no differences were found in event-free survival and overall survival between protocol treatment and observation, although there was a trend toward improved survival with observation. These data fail to support a role for anti-B4-bR as consolidative therapy after bone marrow transplant in patients with B-cell lymphoma.

Original languageEnglish
Pages (from-to)587-596
Number of pages10
JournalLeukemia and Lymphoma
Volume52
Issue number4
DOIs
StatePublished - Apr 1 2011

Keywords

  • Lymphoma
  • adjuvant therapy
  • anti-B4-blocked ricin
  • autologous transplant

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    Furman, R. R., Grossbard, M. L., Johnson, J. L., Pecora, A. L., Cassileth, P. A., Jung, S. H., Peterson, B. A., Nadler, L. M., Freedman, A., Bayer, R. L., Bartlett, N. L., Hurd, D. D., & Cheson, B. D. (2011). A phase III study of anti-B4-blocked ricin as adjuvant therapy post-autologous bone marrow transplant: CALGB 9254. Leukemia and Lymphoma, 52(4), 587-596. https://doi.org/10.3109/10428194.2010.543714