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

Journal Article (Clinical Trial, Phase III;Journal Article;Multicenter Study)

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.

Full Text

Duke Authors

Cited Authors

  • Furman, RR; Grossbard, ML; Johnson, JL; Pecora, AL; Cassileth, PA; Jung, S-H; Peterson, BA; Nadler, LM; Freedman, A; Bayer, R-L; Bartlett, NL; Hurd, DD; Cheson, BD; Cancer Leukemia Group B, ; Eastern Cooperative Oncology Group,

Published Date

  • April 2011

Published In

Volume / Issue

  • 52 / 4

Start / End Page

  • 587 - 596

PubMed ID

  • 21275630

Pubmed Central ID

  • 21275630

Electronic International Standard Serial Number (EISSN)

  • 1029-2403

Digital Object Identifier (DOI)

  • 10.3109/10428194.2010.543714


  • eng

Conference Location

  • United States