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

Jonathan L. Kaufman, Christopher R. Flowers, Karen D. Rados, Gary B. Calandra, Julie M. Vose, L. Becker Hewes, Sagar Lonial, Amelia A. Langston, H. Jean Khoury, Mary Jo Lechowicz, Edmund K. Waller

Research output: Contribution to journalArticle

3 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)76-84
Number of pages9
JournalTransfusion
Volume53
Issue number1
DOIs
StatePublished - Jan 1 2013

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Lymphoma
Clinical Trials
Safety
Stem Cells
Cell Transplantation
Granulocyte Colony-Stimulating Factor
Hematopoietic Stem Cells
Transplants
Blood Component Removal
Rituximab
JM 3100
Natural Killer Cells
Blood Cells
Neutrophils
Arm
B-Lymphocytes
Blood Platelets
Cell Count
T-Lymphocytes

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology
  • Hematology

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A prospective clinical trial evaluating the safety and efficacy of the combination of rituximab and plerixafor as a mobilization regimen for patients with lymphoma. / Kaufman, Jonathan L.; Flowers, Christopher R.; Rados, Karen D.; Calandra, Gary B.; Vose, Julie M.; Hewes, L. Becker; Lonial, Sagar; Langston, Amelia A.; Khoury, H. Jean; Lechowicz, Mary Jo; Waller, Edmund K.

In: Transfusion, Vol. 53, No. 1, 01.01.2013, p. 76-84.

Research output: Contribution to journalArticle

Kaufman, JL, Flowers, CR, Rados, KD, Calandra, GB, Vose, JM, Hewes, LB, Lonial, S, Langston, AA, Khoury, HJ, Lechowicz, MJ & Waller, EK 2013, 'A prospective clinical trial evaluating the safety and efficacy of the combination of rituximab and plerixafor as a mobilization regimen for patients with lymphoma', Transfusion, vol. 53, no. 1, pp. 76-84. https://doi.org/10.1111/j.1537-2995.2012.03719.x
Kaufman, Jonathan L. ; Flowers, Christopher R. ; Rados, Karen D. ; Calandra, Gary B. ; Vose, Julie M. ; Hewes, L. Becker ; Lonial, Sagar ; Langston, Amelia A. ; Khoury, H. Jean ; Lechowicz, Mary Jo ; Waller, Edmund K. / A prospective clinical trial evaluating the safety and efficacy of the combination of rituximab and plerixafor as a mobilization regimen for patients with lymphoma. In: Transfusion. 2013 ; Vol. 53, No. 1. pp. 76-84.
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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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T1 - A prospective clinical trial evaluating the safety and efficacy of the combination of rituximab and plerixafor as a mobilization regimen for patients with lymphoma

AU - Kaufman, Jonathan L.

AU - Flowers, Christopher R.

AU - Rados, Karen D.

AU - Calandra, Gary B.

AU - Vose, Julie M.

AU - Hewes, L. Becker

AU - Lonial, Sagar

AU - Langston, Amelia A.

AU - Khoury, H. Jean

AU - Lechowicz, Mary Jo

AU - Waller, Edmund K.

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N2 - 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.

AB - 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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