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.

journal_name

Leuk Lymphoma

journal_title

Leukemia & lymphoma

authors

Furman RR,Grossbard ML,Johnson JL,Pecora AL,Cassileth PA,Jung SH,Peterson BA,Nadler LM,Freedman A,Bayer RL,Bartlett NL,Hurd DD,Cheson BD,Cancer Leukemia Group B.,Eastern Cooperative Oncology Group.

doi

10.3109/10428194.2010.543714

subject

Has Abstract

pub_date

2011-04-01 00:00:00

pages

587-96

issue

4

eissn

1042-8194

issn

1029-2403

journal_volume

52

pub_type

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