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

Overview

MeSH

  • Adolescent
  • Adult
  • Aged
  • Chemotherapy, Adjuvant
  • Female
  • Humans
  • Male
  • Middle Aged
  • Survival Analysis
  • Transplantation Conditioning
  • Treatment Outcome
  • Young Adult

MeSH Major

  • Adjuvants, Immunologic
  • Bone Marrow Transplantation
  • Immunoconjugates
  • Lymphoma, B-Cell
  • Ricin
  • Transplantation, Autologous

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.

publication date

  • April 2011

has subject area

  • Adjuvants, Immunologic
  • Adolescent
  • Adult
  • Aged
  • Bone Marrow Transplantation
  • Chemotherapy, Adjuvant
  • Female
  • Humans
  • Immunoconjugates
  • Lymphoma, B-Cell
  • Male
  • Middle Aged
  • Ricin
  • Survival Analysis
  • Transplantation Conditioning
  • Transplantation, Autologous
  • Treatment Outcome
  • Young Adult

Research

keywords

  • Clinical Trial, Phase III
  • Journal Article
  • Multicenter Study
  • Randomized Controlled Trial

Identity

Language

  • eng

PubMed Central ID

  • PMC3682835

Digital Object Identifier (DOI)

  • 10.3109/10428194.2010.543714

PubMed ID

  • 21275630

Additional Document Info

start page

  • 587

end page

  • 596

volume

  • 52

number

  • 4