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 Journal Article
| Authors: | Wagner-Johnston, N. D.; Goy, A.; Rodriguez, M. A.; Ehmann, W. C.; Hamlin, P. A.; Radford, J.; Thieblemont, C.; Suh, C.; Sweetenham, J.; Huang, Y. F.; Sullivan, S. T.; Vandendries, E. R.; Gisselbrecht, C. |
| Article Title: | 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 |
| Abstract: | 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. |
| Keywords: | rituximab; immunotherapy; therapy; family; dlbcl; malignancies; transplant; inotuzumab ozogamicin; potent; autologous; antitumor antibiotics; effective salvage regimen; immunoconjugate; calicheamicins |
| Journal Title: | Leukemia and Lymphoma |
| Volume: | 56 |
| Issue: | 10 |
| ISSN: | 1042-8194 |
| Publisher: | Taylor & Francis Group |
| Date Published: | 2015-10-01 |
| Start Page: | 2863 |
| End Page: | 2869 |
| Language: | English |
| ACCESSION: | WOS:000365241700017 |
| DOI: | 10.3109/10428194.2015.1017821 |
| PROVIDER: | wos |
| PUBMED: | 25707288 |
| Notes: | Article -- Source: Wos |
