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

Leuk Lymphoma. 2011 Apr;52(4):587-96. doi: 10.3109/10428194.2010.543714. Epub 2011 Jan 28.

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 types

  • Clinical Trial, Phase III
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural

MeSH terms

  • Adjuvants, Immunologic / adverse effects
  • Adjuvants, Immunologic / pharmacokinetics
  • Adjuvants, Immunologic / therapeutic use*
  • Adolescent
  • Adult
  • Aged
  • Bone Marrow Transplantation*
  • Chemotherapy, Adjuvant
  • Female
  • Humans
  • Immunoconjugates / adverse effects
  • Immunoconjugates / pharmacokinetics
  • Immunoconjugates / therapeutic use*
  • Lymphoma, B-Cell / drug therapy
  • Lymphoma, B-Cell / therapy*
  • Male
  • Middle Aged
  • Ricin / adverse effects
  • Ricin / pharmacokinetics
  • Ricin / therapeutic use*
  • Survival Analysis
  • Transplantation Conditioning
  • Transplantation, Autologous*
  • Treatment Outcome
  • Young Adult

Substances

  • Adjuvants, Immunologic
  • Immunoconjugates
  • anti-B4 blocked ricin immunoconjugate
  • Ricin