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    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.

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    Authors
    Wagner-Johnston, N
    Goy, A
    Rodriguez, M
    Ehmann, W
    Hamlin, P
    Radford, John A
    Thieblemont, C
    Suh, C
    Sweetenham, J
    Huang, Y
    Sullivan, S
    Vandendries, E
    Gisselbrecht, C
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    Affiliation
    Washington University School of Medicine , St Louis
    Issue Date
    2015-10
    
    Metadata
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    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.
    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 Lymphoma
    Journal
    Leukemia & Lymphoma
    URI
    http://hdl.handle.net/10541/592952
    DOI
    10.3109/10428194.2015.1017821
    PubMed ID
    25707288
    Type
    Article
    Language
    en
    ISSN
    1029-2403
    ae974a485f413a2113503eed53cd6c53
    10.3109/10428194.2015.1017821
    Scopus Count
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    All Christie Publications

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