Phase III prospective randomized double-blind placebo-controlled trial of plerixafor plus granulocyte colony-stimulating factor compared with placebo plus granulocyte colony-stimulating factor for autologous stem-cell mobilization and transplantation for patients with non-Hodgkin's lymphoma

John F. DiPersio, Ivana Micallef, Patrick J. Stiff, Brian J. Bolwell, Richard T. Maziarz, Eric Jacobsen, Auayporn Nademanee, John McCarty, Gary Bridger, Gary Calandra

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Abstract

Purpose: This study evaluates the safety and efficacy of plerixafor (AMD3100), a CXCR4 antagonist, in mobilizing hematopoietic stem cells for autologous stem-cell transplantation in non-Hodgkin's lymphoma (NHL) patients. Patients and Methods: This is a phase III, multicenter, randomized (1:1), double-blind, placebo-controlled study. Patients with non-Hodgkin's lymphoma requiring an autologous hematopoietic stem-cell transplantation in first or second complete or partial remission were eligible. Patients received granulocyte colony-stimulating factor (G-CSF; 10 μg/kg) subcutaneously daily for up to 8 days. Beginning on evening of day 4 and continuing daily for up to 4 days, patients received either plerixafor (240 μg/kg) or placebo subcutaneously. Starting on day 5, patients began daily apheresis for up to 4 days or until ≥ 5 × 106 CD34+ cells/kg were collected. The primary end point was the percentage of patients who collected ≥ 5 × 106 CD34+ cells/kg in 4 or fewer apheresis days. Results: This report presents all data for all patients (n = 298) through 12 months follow-up. Eighty-nine (59%) of 150 patients in the plerixafor group and 29 (20%) of 148 patients in the placebo group met the primary end point (P < .001). One hundred thirty-five patients (90%) in plerixafor group and 82 patients (55%) in placebo group underwent transplantation after initial mobilization. Median time to engraftment was similar in both groups. The most common plerixafor-associated adverse events were GI disorders and injection site reactions. Conclusion: Plerixafor and G-CSF were well tolerated and resulted in a significantly higher proportion of patients with non-Hodgkin's lymphoma achieving the optimal CD34+ cell target for transplantation in fewer apheresis days, compared with G-CSF alone.

Original languageEnglish (US)
Pages (from-to)4767-4773
Number of pages7
JournalJournal of Clinical Oncology
Volume27
Issue number28
DOIs
StatePublished - Oct 1 2009

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Hematopoietic Stem Cell Mobilization
Stem Cell Transplantation
Granulocyte Colony-Stimulating Factor
Non-Hodgkin's Lymphoma
Placebos
Blood Component Removal
JM 3100
Hematopoietic Stem Cell Transplantation
Cell Transplantation
Hematopoietic Stem Cells

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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Phase III prospective randomized double-blind placebo-controlled trial of plerixafor plus granulocyte colony-stimulating factor compared with placebo plus granulocyte colony-stimulating factor for autologous stem-cell mobilization and transplantation for patients with non-Hodgkin's lymphoma. / DiPersio, John F.; Micallef, Ivana; Stiff, Patrick J.; Bolwell, Brian J.; Maziarz, Richard T.; Jacobsen, Eric; Nademanee, Auayporn; McCarty, John; Bridger, Gary; Calandra, Gary.

In: Journal of Clinical Oncology, Vol. 27, No. 28, 01.10.2009, p. 4767-4773.

Research output: Contribution to journalArticle

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title = "Phase III prospective randomized double-blind placebo-controlled trial of plerixafor plus granulocyte colony-stimulating factor compared with placebo plus granulocyte colony-stimulating factor for autologous stem-cell mobilization and transplantation for patients with non-Hodgkin's lymphoma",
abstract = "Purpose: This study evaluates the safety and efficacy of plerixafor (AMD3100), a CXCR4 antagonist, in mobilizing hematopoietic stem cells for autologous stem-cell transplantation in non-Hodgkin's lymphoma (NHL) patients. Patients and Methods: This is a phase III, multicenter, randomized (1:1), double-blind, placebo-controlled study. Patients with non-Hodgkin's lymphoma requiring an autologous hematopoietic stem-cell transplantation in first or second complete or partial remission were eligible. Patients received granulocyte colony-stimulating factor (G-CSF; 10 μg/kg) subcutaneously daily for up to 8 days. Beginning on evening of day 4 and continuing daily for up to 4 days, patients received either plerixafor (240 μg/kg) or placebo subcutaneously. Starting on day 5, patients began daily apheresis for up to 4 days or until ≥ 5 × 106 CD34+ cells/kg were collected. The primary end point was the percentage of patients who collected ≥ 5 × 106 CD34+ cells/kg in 4 or fewer apheresis days. Results: This report presents all data for all patients (n = 298) through 12 months follow-up. Eighty-nine (59{\%}) of 150 patients in the plerixafor group and 29 (20{\%}) of 148 patients in the placebo group met the primary end point (P < .001). One hundred thirty-five patients (90{\%}) in plerixafor group and 82 patients (55{\%}) in placebo group underwent transplantation after initial mobilization. Median time to engraftment was similar in both groups. The most common plerixafor-associated adverse events were GI disorders and injection site reactions. Conclusion: Plerixafor and G-CSF were well tolerated and resulted in a significantly higher proportion of patients with non-Hodgkin's lymphoma achieving the optimal CD34+ cell target for transplantation in fewer apheresis days, compared with G-CSF alone.",
author = "DiPersio, {John F.} and Ivana Micallef and Stiff, {Patrick J.} and Bolwell, {Brian J.} and Maziarz, {Richard T.} and Eric Jacobsen and Auayporn Nademanee and John McCarty and Gary Bridger and Gary Calandra",
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T1 - Phase III prospective randomized double-blind placebo-controlled trial of plerixafor plus granulocyte colony-stimulating factor compared with placebo plus granulocyte colony-stimulating factor for autologous stem-cell mobilization and transplantation for patients with non-Hodgkin's lymphoma

AU - DiPersio, John F.

AU - Micallef, Ivana

AU - Stiff, Patrick J.

AU - Bolwell, Brian J.

AU - Maziarz, Richard T.

AU - Jacobsen, Eric

AU - Nademanee, Auayporn

AU - McCarty, John

AU - Bridger, Gary

AU - Calandra, Gary

PY - 2009/10/1

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N2 - Purpose: This study evaluates the safety and efficacy of plerixafor (AMD3100), a CXCR4 antagonist, in mobilizing hematopoietic stem cells for autologous stem-cell transplantation in non-Hodgkin's lymphoma (NHL) patients. Patients and Methods: This is a phase III, multicenter, randomized (1:1), double-blind, placebo-controlled study. Patients with non-Hodgkin's lymphoma requiring an autologous hematopoietic stem-cell transplantation in first or second complete or partial remission were eligible. Patients received granulocyte colony-stimulating factor (G-CSF; 10 μg/kg) subcutaneously daily for up to 8 days. Beginning on evening of day 4 and continuing daily for up to 4 days, patients received either plerixafor (240 μg/kg) or placebo subcutaneously. Starting on day 5, patients began daily apheresis for up to 4 days or until ≥ 5 × 106 CD34+ cells/kg were collected. The primary end point was the percentage of patients who collected ≥ 5 × 106 CD34+ cells/kg in 4 or fewer apheresis days. Results: This report presents all data for all patients (n = 298) through 12 months follow-up. Eighty-nine (59%) of 150 patients in the plerixafor group and 29 (20%) of 148 patients in the placebo group met the primary end point (P < .001). One hundred thirty-five patients (90%) in plerixafor group and 82 patients (55%) in placebo group underwent transplantation after initial mobilization. Median time to engraftment was similar in both groups. The most common plerixafor-associated adverse events were GI disorders and injection site reactions. Conclusion: Plerixafor and G-CSF were well tolerated and resulted in a significantly higher proportion of patients with non-Hodgkin's lymphoma achieving the optimal CD34+ cell target for transplantation in fewer apheresis days, compared with G-CSF alone.

AB - Purpose: This study evaluates the safety and efficacy of plerixafor (AMD3100), a CXCR4 antagonist, in mobilizing hematopoietic stem cells for autologous stem-cell transplantation in non-Hodgkin's lymphoma (NHL) patients. Patients and Methods: This is a phase III, multicenter, randomized (1:1), double-blind, placebo-controlled study. Patients with non-Hodgkin's lymphoma requiring an autologous hematopoietic stem-cell transplantation in first or second complete or partial remission were eligible. Patients received granulocyte colony-stimulating factor (G-CSF; 10 μg/kg) subcutaneously daily for up to 8 days. Beginning on evening of day 4 and continuing daily for up to 4 days, patients received either plerixafor (240 μg/kg) or placebo subcutaneously. Starting on day 5, patients began daily apheresis for up to 4 days or until ≥ 5 × 106 CD34+ cells/kg were collected. The primary end point was the percentage of patients who collected ≥ 5 × 106 CD34+ cells/kg in 4 or fewer apheresis days. Results: This report presents all data for all patients (n = 298) through 12 months follow-up. Eighty-nine (59%) of 150 patients in the plerixafor group and 29 (20%) of 148 patients in the placebo group met the primary end point (P < .001). One hundred thirty-five patients (90%) in plerixafor group and 82 patients (55%) in placebo group underwent transplantation after initial mobilization. Median time to engraftment was similar in both groups. The most common plerixafor-associated adverse events were GI disorders and injection site reactions. Conclusion: Plerixafor and G-CSF were well tolerated and resulted in a significantly higher proportion of patients with non-Hodgkin's lymphoma achieving the optimal CD34+ cell target for transplantation in fewer apheresis days, compared with G-CSF alone.

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