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.

• Authors: Nina D Wagner-Johnston, Andrè Goy, Maria A Rodriguez, W Christopher Ehmann, Paul A Hamlin, John Radford, Catherine Thieblemont, Cheolwon Suh, John Sweetenham, Yifan Huang, Sharon T Sullivan, Erik R Vandendries, Christian Gisselbrecht
• Journal: Leukemia & lymphoma (Leuk Lymphoma) Vol. 56 Issue 10 Pg. 2863-9 ( 2015) ISSN: 1029-2403 [Electronic] United States
• PMID: 25707288 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Antibodies, Monoclonal, Humanized
• Rituximab
• Inotuzumab Ozogamicin

Topics

• Adult
• Aged
• Antibodies, Monoclonal, Humanized (administration & dosage)
• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Drug Resistance, Neoplasm
• Female
• Hematopoietic Stem Cell Mobilization (methods)
• Hematopoietic Stem Cell Transplantation (adverse effects, methods)
• Humans
• Inotuzumab Ozogamicin
• Kaplan-Meier Estimate
• Lymphoma, Large B-Cell, Diffuse (diagnosis, mortality, therapy)
• Male
• Middle Aged
• Neoplasm Staging
• Odds Ratio
• Peripheral Blood Stem Cell Transplantation (adverse effects, methods)
• Prognosis
• Recurrence
• Remission Induction
• Retreatment
• Rituximab (administration & dosage)
• Transplantation Conditioning
• Transplantation, Autologous
• Treatment Outcome
• Young Adult