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Abstracts Not Selected for Presentation| November 16, 2005

A Humanized HLA-DR Antibody (HU1D10, Apolizumab) in Combination with G-CSF (Filgrastim) for the Treatment of Non-Hodgkin’s Lymphoma: A Pilot Study.

Juergen Rech, MD,

Juergen Rech, MD *

¹Department of Medicine III, University of Erlangen-Nuremberg, Erlangen, Germany; ²Division for Stem Cell and Immunotherapy, 2nd Medical Department, University of Kiel, Kiel, Germany; ³Department of Medicine III, University of Erlangen-Nuremberg, Erlangen, Germany; ⁴Medical Department III, University of Erlangen-Nuremberg, Erlangen, Germany; ⁵Division of Nephrology, University Schleswig-Holstein, Kiel, Germany; ⁶Institute for Pathology, University Erlangen-Nuremberg, Erlangen, Germany; ⁷Protein Design Laboratories, Fremont, CA, USA; ⁸Holden Comprehensive Cancer Center, University of Iowa, Iowa City, IA, USA; ⁹Division for Stem Cell and Immunotherapy, 2nd Medical Department, University of Kiel, Kiel, Germany and ¹⁰Division of Nephrology, University of Schleswig-Holstein, Kiel, Germany.

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Roland Repp, MD,

Roland Repp, MD

¹Department of Medicine III, University of Erlangen-Nuremberg, Erlangen, Germany; ²Division for Stem Cell and Immunotherapy, 2nd Medical Department, University of Kiel, Kiel, Germany; ³Department of Medicine III, University of Erlangen-Nuremberg, Erlangen, Germany; ⁴Medical Department III, University of Erlangen-Nuremberg, Erlangen, Germany; ⁵Division of Nephrology, University Schleswig-Holstein, Kiel, Germany; ⁶Institute for Pathology, University Erlangen-Nuremberg, Erlangen, Germany; ⁷Protein Design Laboratories, Fremont, CA, USA; ⁸Holden Comprehensive Cancer Center, University of Iowa, Iowa City, IA, USA; ⁹Division for Stem Cell and Immunotherapy, 2nd Medical Department, University of Kiel, Kiel, Germany and ¹⁰Division of Nephrology, University of Schleswig-Holstein, Kiel, Germany.

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Dorit Rech, MD,

Dorit Rech, MD *

¹Department of Medicine III, University of Erlangen-Nuremberg, Erlangen, Germany; ²Division for Stem Cell and Immunotherapy, 2nd Medical Department, University of Kiel, Kiel, Germany; ³Department of Medicine III, University of Erlangen-Nuremberg, Erlangen, Germany; ⁴Medical Department III, University of Erlangen-Nuremberg, Erlangen, Germany; ⁵Division of Nephrology, University Schleswig-Holstein, Kiel, Germany; ⁶Institute for Pathology, University Erlangen-Nuremberg, Erlangen, Germany; ⁷Protein Design Laboratories, Fremont, CA, USA; ⁸Holden Comprehensive Cancer Center, University of Iowa, Iowa City, IA, USA; ⁹Division for Stem Cell and Immunotherapy, 2nd Medical Department, University of Kiel, Kiel, Germany and ¹⁰Division of Nephrology, University of Schleswig-Holstein, Kiel, Germany.

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Bernhard Stockmeyer, MD,

Bernhard Stockmeyer, MD *

¹Department of Medicine III, University of Erlangen-Nuremberg, Erlangen, Germany; ²Division for Stem Cell and Immunotherapy, 2nd Medical Department, University of Kiel, Kiel, Germany; ³Department of Medicine III, University of Erlangen-Nuremberg, Erlangen, Germany; ⁴Medical Department III, University of Erlangen-Nuremberg, Erlangen, Germany; ⁵Division of Nephrology, University Schleswig-Holstein, Kiel, Germany; ⁶Institute for Pathology, University Erlangen-Nuremberg, Erlangen, Germany; ⁷Protein Design Laboratories, Fremont, CA, USA; ⁸Holden Comprehensive Cancer Center, University of Iowa, Iowa City, IA, USA; ⁹Division for Stem Cell and Immunotherapy, 2nd Medical Department, University of Kiel, Kiel, Germany and ¹⁰Division of Nephrology, University of Schleswig-Holstein, Kiel, Germany.

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Michael Dechant, MD,

Michael Dechant, MD *

¹Department of Medicine III, University of Erlangen-Nuremberg, Erlangen, Germany; ²Division for Stem Cell and Immunotherapy, 2nd Medical Department, University of Kiel, Kiel, Germany; ³Department of Medicine III, University of Erlangen-Nuremberg, Erlangen, Germany; ⁴Medical Department III, University of Erlangen-Nuremberg, Erlangen, Germany; ⁵Division of Nephrology, University Schleswig-Holstein, Kiel, Germany; ⁶Institute for Pathology, University Erlangen-Nuremberg, Erlangen, Germany; ⁷Protein Design Laboratories, Fremont, CA, USA; ⁸Holden Comprehensive Cancer Center, University of Iowa, Iowa City, IA, USA; ⁹Division for Stem Cell and Immunotherapy, 2nd Medical Department, University of Kiel, Kiel, Germany and ¹⁰Division of Nephrology, University of Schleswig-Holstein, Kiel, Germany.

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Gerald Niedobitek, MD,

Gerald Niedobitek, MD *

¹Department of Medicine III, University of Erlangen-Nuremberg, Erlangen, Germany; ²Division for Stem Cell and Immunotherapy, 2nd Medical Department, University of Kiel, Kiel, Germany; ³Department of Medicine III, University of Erlangen-Nuremberg, Erlangen, Germany; ⁴Medical Department III, University of Erlangen-Nuremberg, Erlangen, Germany; ⁵Division of Nephrology, University Schleswig-Holstein, Kiel, Germany; ⁶Institute for Pathology, University Erlangen-Nuremberg, Erlangen, Germany; ⁷Protein Design Laboratories, Fremont, CA, USA; ⁸Holden Comprehensive Cancer Center, University of Iowa, Iowa City, IA, USA; ⁹Division for Stem Cell and Immunotherapy, 2nd Medical Department, University of Kiel, Kiel, Germany and ¹⁰Division of Nephrology, University of Schleswig-Holstein, Kiel, Germany.

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Tilman Pearce, MD,

Tilman Pearce, MD *

¹Department of Medicine III, University of Erlangen-Nuremberg, Erlangen, Germany; ²Division for Stem Cell and Immunotherapy, 2nd Medical Department, University of Kiel, Kiel, Germany; ³Department of Medicine III, University of Erlangen-Nuremberg, Erlangen, Germany; ⁴Medical Department III, University of Erlangen-Nuremberg, Erlangen, Germany; ⁵Division of Nephrology, University Schleswig-Holstein, Kiel, Germany; ⁶Institute for Pathology, University Erlangen-Nuremberg, Erlangen, Germany; ⁷Protein Design Laboratories, Fremont, CA, USA; ⁸Holden Comprehensive Cancer Center, University of Iowa, Iowa City, IA, USA; ⁹Division for Stem Cell and Immunotherapy, 2nd Medical Department, University of Kiel, Kiel, Germany and ¹⁰Division of Nephrology, University of Schleswig-Holstein, Kiel, Germany.

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Georg Weiner, MD,

Georg Weiner, MD *

¹Department of Medicine III, University of Erlangen-Nuremberg, Erlangen, Germany; ²Division for Stem Cell and Immunotherapy, 2nd Medical Department, University of Kiel, Kiel, Germany; ³Department of Medicine III, University of Erlangen-Nuremberg, Erlangen, Germany; ⁴Medical Department III, University of Erlangen-Nuremberg, Erlangen, Germany; ⁵Division of Nephrology, University Schleswig-Holstein, Kiel, Germany; ⁶Institute for Pathology, University Erlangen-Nuremberg, Erlangen, Germany; ⁷Protein Design Laboratories, Fremont, CA, USA; ⁸Holden Comprehensive Cancer Center, University of Iowa, Iowa City, IA, USA; ⁹Division for Stem Cell and Immunotherapy, 2nd Medical Department, University of Kiel, Kiel, Germany and ¹⁰Division of Nephrology, University of Schleswig-Holstein, Kiel, Germany.

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Martin Gramatzki, MD,

Martin Gramatzki, MD

¹Department of Medicine III, University of Erlangen-Nuremberg, Erlangen, Germany; ²Division for Stem Cell and Immunotherapy, 2nd Medical Department, University of Kiel, Kiel, Germany; ³Department of Medicine III, University of Erlangen-Nuremberg, Erlangen, Germany; ⁴Medical Department III, University of Erlangen-Nuremberg, Erlangen, Germany; ⁵Division of Nephrology, University Schleswig-Holstein, Kiel, Germany; ⁶Institute for Pathology, University Erlangen-Nuremberg, Erlangen, Germany; ⁷Protein Design Laboratories, Fremont, CA, USA; ⁸Holden Comprehensive Cancer Center, University of Iowa, Iowa City, IA, USA; ⁹Division for Stem Cell and Immunotherapy, 2nd Medical Department, University of Kiel, Kiel, Germany and ¹⁰Division of Nephrology, University of Schleswig-Holstein, Kiel, Germany.

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Thomas Valerius, MD.

Thomas Valerius, MD.

¹Department of Medicine III, University of Erlangen-Nuremberg, Erlangen, Germany; ²Division for Stem Cell and Immunotherapy, 2nd Medical Department, University of Kiel, Kiel, Germany; ³Department of Medicine III, University of Erlangen-Nuremberg, Erlangen, Germany; ⁴Medical Department III, University of Erlangen-Nuremberg, Erlangen, Germany; ⁵Division of Nephrology, University Schleswig-Holstein, Kiel, Germany; ⁶Institute for Pathology, University Erlangen-Nuremberg, Erlangen, Germany; ⁷Protein Design Laboratories, Fremont, CA, USA; ⁸Holden Comprehensive Cancer Center, University of Iowa, Iowa City, IA, USA; ⁹Division for Stem Cell and Immunotherapy, 2nd Medical Department, University of Kiel, Kiel, Germany and ¹⁰Division of Nephrology, University of Schleswig-Holstein, Kiel, Germany.

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Blood (2005) 106 (11): 4775.

https://doi.org/10.1182/blood.V106.11.4775.4775

Abstract

Apolizumab is a humanized monoclonal antibody against a polymorhic epitope on HLA DRß, which demonstrated evidence for therapeutic activity in follicular lymphoma patients. In preclinical studies, we had previously reported that granulocyte colony-stimulating factor (G-CSF) treatment significantly enhanced lymphoma cell killing by HLA class II antibodies - including Apolizumab. These results suggested a pivotal study of Apolizumab and G-CSF (Filgrastim). In this trial, we treated 6 patients with relapsed or refractory 1D10-positive Non-Hodgkin’s lymphoma with fixed doses of Filgrastim and variable doses of Apolizumab from 0,15 mg/m2 to 1,5 mg/m2. The combination was clinically well tolerated, and all patients received their scheduled drug doses. Two patients experienced grade III/IV hematological toxicity (thrombocytopenia and autoimmune hemolytic anemia, respetively). Another patient developed a pruritic skin rash, which was considered a probably treatment related grade II skin toxicity. On patient with progressive mantle cell lymphoma died from progressive disease at the end of the three month post-treatment period. Interestingly, two patients with follicular lymphoma, who received intensified Apolizumab treatment on a three times weekly schedule, experienced prolonged stabilization of their disease for 12 and for more than 36 month, respectively. In conclusion, this small pilot study suggests that a combination of HLA-class II antibodies and G-CSF is clinically feasable, and that it may induce clinically relevant response in select patients.

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Corresponding author

2005, The American Society of Hematology

2005

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