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.
Authors
Wagner-Johnston, NGoy, A
Rodriguez, M
Ehmann, W
Hamlin, P
Radford, John A
Thieblemont, C
Suh, C
Sweetenham, J
Huang, Y
Sullivan, S
Vandendries, E
Gisselbrecht, C
Affiliation
Washington University School of Medicine , St LouisIssue Date
2015-10
Metadata
Show full item recordAbstract
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.Citation
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. 2015, 56 (10):2863-9 Leuk LymphomaJournal
Leukemia & LymphomaDOI
10.3109/10428194.2015.1017821PubMed ID
25707288Type
ArticleLanguage
enISSN
1029-2403ae974a485f413a2113503eed53cd6c53
10.3109/10428194.2015.1017821