TY - JOUR
T1 - A phase 2 study of inotuzumab ozogamicin and rituximab, followed by autologous stem cell transplant in patients with relapsed/refractory diffuse large B-cell lymphoma
AU - Wagner-Johnston, Nina D.
AU - Goy, Andrè
AU - Rodriguez, Maria A.
AU - Ehmann, W. Christopher
AU - Hamlin, Paul A.
AU - Radford, John
AU - Thieblemont, Catherine
AU - Suh, Cheolwon
AU - Sweetenham, John
AU - Huang, Yifan
AU - Sullivan, Sharon T.
AU - Vandendries, Erik R.
AU - Gisselbrecht, Christian
N1 - Publisher Copyright:
© 2015 Informa UK, Ltd.
PY - 2015/10/3
Y1 - 2015/10/3
N2 - This study evaluated the safety and efficacy of inotuzumab ozogamicin (INO), a targeted humanized anti-CD22 antibody conjugated to calicheamicin, plus rituximab (R-INO) every 3 weeks, up to six cycles, followed by high dose therapy and autologous stem cell transplant (HDT-aSCT) in patients with high-risk relapsed/refractory diffuse large B-cell lymphoma (DLBCL). The primary endpoint was overall response (OR) rate after three cycles of R-INO. Sixty-three patients were enrolled. Common grade 3/4 adverse events during R-INO treatment were thrombocytopenia, lymphopenia and neutropenia. OR rate after three cycles of R-INO was 28.6% (95% confidence interval: 17.9-41.4). Eighteen patients underwent HDT-aSCT; 2-year progression-free survival (PFS) for these patients was 61.1%. Serious infections and hepatic toxicity following aSCT occurred in 33% and 22%, respectively. One- and 2-year PFS rates for all enrolled patients were 28.9% and 25.3%, respectively (median, 3.0 months). R-INO had lower than expected activity as a salvage regimen for transplant eligible patients with DLBCL.
AB - This study evaluated the safety and efficacy of inotuzumab ozogamicin (INO), a targeted humanized anti-CD22 antibody conjugated to calicheamicin, plus rituximab (R-INO) every 3 weeks, up to six cycles, followed by high dose therapy and autologous stem cell transplant (HDT-aSCT) in patients with high-risk relapsed/refractory diffuse large B-cell lymphoma (DLBCL). The primary endpoint was overall response (OR) rate after three cycles of R-INO. Sixty-three patients were enrolled. Common grade 3/4 adverse events during R-INO treatment were thrombocytopenia, lymphopenia and neutropenia. OR rate after three cycles of R-INO was 28.6% (95% confidence interval: 17.9-41.4). Eighteen patients underwent HDT-aSCT; 2-year progression-free survival (PFS) for these patients was 61.1%. Serious infections and hepatic toxicity following aSCT occurred in 33% and 22%, respectively. One- and 2-year PFS rates for all enrolled patients were 28.9% and 25.3%, respectively (median, 3.0 months). R-INO had lower than expected activity as a salvage regimen for transplant eligible patients with DLBCL.
KW - DLBCL
KW - Inotuzumab ozogamicin
KW - autologous
KW - immunotherapy
KW - rituximab
KW - transplant
UR - http://www.scopus.com/inward/record.url?scp=84938897233&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84938897233&partnerID=8YFLogxK
U2 - 10.3109/10428194.2015.1017821
DO - 10.3109/10428194.2015.1017821
M3 - Article
C2 - 25707288
AN - SCOPUS:84938897233
SN - 1042-8194
VL - 56
SP - 2863
EP - 2869
JO - Leukemia and Lymphoma
JF - Leukemia and Lymphoma
IS - 10
ER -