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

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

doi:10.3109/10428194.2015.1017821

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

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

School of Medicine

Hackensack Meridian School of Medicine

Research output: Contribution to journal › Article › peer-review

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.

Original language	English
Pages (from-to)	2863-2869
Number of pages	7
Journal	Leukemia and Lymphoma
Volume	56
Issue number	10
DOIs	https://doi.org/10.3109/10428194.2015.1017821
State	Published - Oct 3 2015

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

ASJC Scopus subject areas

Hematology
Oncology
Cancer Research

Keywords

DLBCL
Inotuzumab ozogamicin
autologous
immunotherapy
rituximab
transplant

Access to Document

10.3109/10428194.2015.1017821

Cite this

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., Sullivan, S. T., Vandendries, E. R., & Gisselbrecht, C. (2015). 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. Leukemia and Lymphoma, 56(10), 2863-2869. https://doi.org/10.3109/10428194.2015.1017821

@article{209c64b9051d45e6b242cbe5d8b4affd,

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 = "DLBCL, Inotuzumab ozogamicin, autologous, immunotherapy, rituximab, transplant",

author = "Wagner-Johnston, \{Nina D.\} and Andr{\`e} Goy and Rodriguez, \{Maria A.\} and Ehmann, \{W. Christopher\} and Hamlin, \{Paul A.\} and John Radford and Catherine Thieblemont and Cheolwon Suh and John Sweetenham and Yifan Huang and Sullivan, \{Sharon T.\} and Vandendries, \{Erik R.\} and Christian Gisselbrecht",

note = "Publisher Copyright: {\textcopyright} 2015 Informa UK, Ltd.",

year = "2015",

month = oct,

day = "3",

doi = "10.3109/10428194.2015.1017821",

language = "English",

volume = "56",

pages = "2863--2869",

journal = "Leukemia and Lymphoma",

issn = "1042-8194",

publisher = "Taylor and Francis Ltd.",

number = "10",

}

Wagner-Johnston, ND, Goy, A, Rodriguez, MA, Ehmann, WC, Hamlin, PA, Radford, J, Thieblemont, C, Suh, C, Sweetenham, J, Huang, Y, Sullivan, ST, Vandendries, ER & Gisselbrecht, C 2015, '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', Leukemia and Lymphoma, vol. 56, no. 10, pp. 2863-2869. https://doi.org/10.3109/10428194.2015.1017821

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. / Wagner-Johnston, Nina D.; Goy, Andrè; Rodriguez, Maria A. et al.
In: Leukemia and Lymphoma, Vol. 56, No. 10, 03.10.2015, p. 2863-2869.

Research output: Contribution to journal › Article › peer-review

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

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 - https://www.scopus.com/pages/publications/84938897233

U2 - 10.3109/10428194.2015.1017821

DO - 10.3109/10428194.2015.1017821

M3 - Article

C2 - 25707288

SN - 1042-8194

VL - 56

SP - 2863

EP - 2869

JO - Leukemia and Lymphoma

JF - Leukemia and Lymphoma

IS - 10

ER -

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

UN SDGs

ASJC Scopus subject areas

Keywords

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