title: A phase III study of anti-B4-blocked ricin as adjuvant therapy post-autologous bone marrow transplant: CALGB 9254.
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.
authors.affiliation: Center for Lymphoma and Myeloma, Weill Cornell Medical College, New York, NY 10065, USA. rrfurman@med.cornell.edu
authors.forename: Richard R
authors.initials: RR
authors.lastname: Furman
authors.forename: Michael L
authors.initials: ML
authors.lastname: Grossbard
authors.forename: Jeffrey L
authors.initials: JL
authors.lastname: Johnson
authors.forename: Andrew L
authors.initials: AL
authors.lastname: Pecora
authors.forename: Peter A
authors.initials: PA
authors.lastname: Cassileth
authors.forename: Sin-Ho
authors.initials: SH
authors.lastname: Jung
authors.forename: Bruce A
authors.initials: BA
authors.lastname: Peterson
authors.forename: Lee M
authors.initials: LM
authors.lastname: Nadler
authors.forename: Arnold
authors.initials: A
authors.lastname: Freedman
authors.forename: Ruthee-Lu
authors.initials: RL
authors.lastname: Bayer
authors.forename: Nancy L
authors.initials: NL
authors.lastname: Bartlett
authors.forename: David D
authors.initials: DD
authors.lastname: Hurd
authors.forename: Bruce D
authors.initials: BD
authors.lastname: Cheson
mesh_terms: D000276:Adjuvants, Immunologic / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D000293:Adolescent; D000328:Adult; D000368:Aged; D016026:Bone Marrow Transplantation; D017024:Chemotherapy, Adjuvant; D005260:Female; D006801:Humans; D018796:Immunoconjugates / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D016393:Lymphoma, B-Cell / Q000188:drug therapy / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D012276:Ricin / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D016019:Survival Analysis; D019172:Transplantation Conditioning; D014182:Transplantation, Autologous; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000276:Adjuvants, Immunologic; D018796:Immunoconjugates; C117142:anti-B4 blocked ricin immunoconjugate; D012276:Ricin