A prospective clinical trial evaluating the safety and efficacy of the combination of rituximab and plerixafor as a mobilization regimen for patients with lymphoma

Authors

  • Jonathan L. Kaufman,

    1. From the Winship Cancer Institute, Emory University School of Medicine, Atlanta, Georgia; the Nebraska Medical Center, Omaha, Nebraska; and Genzyme, a Sanofi Company, Cambridge, Massachusetts.
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  • Christopher R. Flowers,

    1. From the Winship Cancer Institute, Emory University School of Medicine, Atlanta, Georgia; the Nebraska Medical Center, Omaha, Nebraska; and Genzyme, a Sanofi Company, Cambridge, Massachusetts.
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  • Karen D. Rados,

    1. From the Winship Cancer Institute, Emory University School of Medicine, Atlanta, Georgia; the Nebraska Medical Center, Omaha, Nebraska; and Genzyme, a Sanofi Company, Cambridge, Massachusetts.
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  • Gary B. Calandra,

    1. From the Winship Cancer Institute, Emory University School of Medicine, Atlanta, Georgia; the Nebraska Medical Center, Omaha, Nebraska; and Genzyme, a Sanofi Company, Cambridge, Massachusetts.
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  • Julie M. Vose,

    1. From the Winship Cancer Institute, Emory University School of Medicine, Atlanta, Georgia; the Nebraska Medical Center, Omaha, Nebraska; and Genzyme, a Sanofi Company, Cambridge, Massachusetts.
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  • L. Becker Hewes,

    1. From the Winship Cancer Institute, Emory University School of Medicine, Atlanta, Georgia; the Nebraska Medical Center, Omaha, Nebraska; and Genzyme, a Sanofi Company, Cambridge, Massachusetts.
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  • Sagar Lonial,

    1. From the Winship Cancer Institute, Emory University School of Medicine, Atlanta, Georgia; the Nebraska Medical Center, Omaha, Nebraska; and Genzyme, a Sanofi Company, Cambridge, Massachusetts.
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  • Amelia A. Langston,

    1. From the Winship Cancer Institute, Emory University School of Medicine, Atlanta, Georgia; the Nebraska Medical Center, Omaha, Nebraska; and Genzyme, a Sanofi Company, Cambridge, Massachusetts.
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  • H. Jean Khoury,

    1. From the Winship Cancer Institute, Emory University School of Medicine, Atlanta, Georgia; the Nebraska Medical Center, Omaha, Nebraska; and Genzyme, a Sanofi Company, Cambridge, Massachusetts.
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  • Mary Jo Lechowicz,

    1. From the Winship Cancer Institute, Emory University School of Medicine, Atlanta, Georgia; the Nebraska Medical Center, Omaha, Nebraska; and Genzyme, a Sanofi Company, Cambridge, Massachusetts.
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  • Edmund K. Waller

    Corresponding author
    1. From the Winship Cancer Institute, Emory University School of Medicine, Atlanta, Georgia; the Nebraska Medical Center, Omaha, Nebraska; and Genzyme, a Sanofi Company, Cambridge, Massachusetts.
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  • This study was supported by research funding from Sanofi Oncology (formerly Genzyme Corporation).

Edmund K. Waller, MD, PhD, Winship Cancer Institute, Emory University Medical School, 1365B Clifton Road NE, Room B5119, Atlanta, GA 30322; e-mail: ewaller@emory.edu.

Abstract

BACKGROUND: Previous reports suggested that rituximab may impair stem cell collection and posttransplant engraftment in lymphoma patients undergoing autologous hematopoietic progenitor cell transplantation.

STUDY DESIGN AND METHODS: A prospective biologic allocation study examined the effect of adding rituximab to a mobilization regimen of plerixafor and granulocyte–colony-stimulating factor (G-CSF) for patients with CD20+ lymphoma compared with CD20− lymphoma patients mobilized without rituximab. The primary endpoint was safety of the rituximab-containing regimen; secondary endpoints compared the efficiency of stem cell collection, posttransplant engraftment, graft characteristics, mobilization kinetics, immune reconstitution, and engraftment durability between the cohorts of patients with CD20+ and CD20− lymphoma.

RESULTS: Fifteen subjects assigned to each treatment arm were accrued. Both mobilization regimens had similar toxicities. The median number of CD34+ cells collected (7.4 × 106/kg vs. 6.4 × 106/kg) and the median numbers of days of apheresis needed to collect stem cells were not different between the CD20+ and CD20− cohorts. No significant differences in neutrophil engraftment (median, 13.5 days vs. 13 days) or platelet engraftment (22 vs. 21 days) or in graft durability were seen comparing patients with CD20+ versus CD20− lymphoma. There were no significant differences in the kinetics of blood T-cell or natural killer–cell reconstitution comparing the two groups. B-cell reconstitution was delayed in the CD20+ lymphoma group, but this did not translate into a significant increase in infectious complications.

CONCLUSION: Rituximab can be safely added to the combination of plerixafor and G-CSF as a mobilization strategy without excess toxicity or posttransplant engraftment delays for patients with chemosensitive lymphoma undergoing autologous hematopoietic progenitor cell transplantation.

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