A randomized, double-blind trial of filgrastim (granulocyte colony- stimulating factor) versus placebo following allogeneic blood stem cell transplantation

Michael R. Bishop, Stefano R. Tarantolo, Robert B. Geller, James C. Lynch, Philip J. Bierman, Z. Steven Pavletic, Julie M. Vose, Susan Kruse, Suzanne P. Dix, Mary E. Morris, James O. Armitage, Anne Kessinger

Research output: Contribution to journalArticle

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Abstract

Blood stem cell transplantation (BSCT) results in rapid hematopoietic recovery in both the allogeneic and autologous transplant settings. Because of the large numbers of progenitor cells in mobilized blood, the administration of growth factors after transplantation may not provide further acceleration of hematopoietic recovery. A randomized, double-blind, placebo-controlled study was performed to determine the effects of filgrastim (granulocyte colony-stimulating factor; G-CSF) administration on hematopoietic recovery after allogeneic BSCT. Fifty-four patients with hematologic malignancies undergoing a related, HLA-matched allogeneic BSCT were randomly assigned to receive daily filgrastim at 10 μg/kg or placebo starting on the day of transplantation. A minimum of 3 x 106 CD34+ cells/kg in the allograft was required for transplantation. All patients received a standard preparative regimen and a standard regimen for the prevention of graft-versus-host disease (GVHD). The median time to achieve an absolute neutrophil count greater than 0.5 x 109/L was 11 days (range, 9-20 days) for patients who received filgrastim compared with 15 days (range, 10-22 days) for patients who received placebo (P = .0082). The median time to achieve a platelet count greater than 20 x 109/L was 13 days (range, 8-35 days) for patients who received filgrastim compared with 15.5 days (range, 8-42 days) for patients who received placebo (P = .79). There were no significant differences for red blood cell transfusion independence, the incidence of acute GVHD, or 100-day mortality between the groups. The administration of filgrastim appears to be a safe and effective supportive-care measure following allogeneic BSCT. (C) 2000 by The American Society of Hematology.

Original languageEnglish (US)
Pages (from-to)80-85
Number of pages6
JournalBlood
Volume96
Issue number1
StatePublished - Jul 1 2000

Fingerprint

Stem Cell Transplantation
Granulocyte Colony-Stimulating Factor
Stem cells
Blood Cells
Blood
Placebos
Transplantation
Graft vs Host Disease
Grafts
Recovery
Erythrocyte Transfusion
Autografts
Hematologic Neoplasms
Platelets
Platelet Count
Allografts
Filgrastim
Intercellular Signaling Peptides and Proteins
Neutrophils
Stem Cells

ASJC Scopus subject areas

  • Biochemistry
  • Immunology
  • Hematology
  • Cell Biology

Cite this

Bishop, M. R., Tarantolo, S. R., Geller, R. B., Lynch, J. C., Bierman, P. J., Pavletic, Z. S., ... Kessinger, A. (2000). A randomized, double-blind trial of filgrastim (granulocyte colony- stimulating factor) versus placebo following allogeneic blood stem cell transplantation. Blood, 96(1), 80-85.

A randomized, double-blind trial of filgrastim (granulocyte colony- stimulating factor) versus placebo following allogeneic blood stem cell transplantation. / Bishop, Michael R.; Tarantolo, Stefano R.; Geller, Robert B.; Lynch, James C.; Bierman, Philip J.; Pavletic, Z. Steven; Vose, Julie M.; Kruse, Susan; Dix, Suzanne P.; Morris, Mary E.; Armitage, James O.; Kessinger, Anne.

In: Blood, Vol. 96, No. 1, 01.07.2000, p. 80-85.

Research output: Contribution to journalArticle

Bishop, MR, Tarantolo, SR, Geller, RB, Lynch, JC, Bierman, PJ, Pavletic, ZS, Vose, JM, Kruse, S, Dix, SP, Morris, ME, Armitage, JO & Kessinger, A 2000, 'A randomized, double-blind trial of filgrastim (granulocyte colony- stimulating factor) versus placebo following allogeneic blood stem cell transplantation', Blood, vol. 96, no. 1, pp. 80-85.
Bishop, Michael R. ; Tarantolo, Stefano R. ; Geller, Robert B. ; Lynch, James C. ; Bierman, Philip J. ; Pavletic, Z. Steven ; Vose, Julie M. ; Kruse, Susan ; Dix, Suzanne P. ; Morris, Mary E. ; Armitage, James O. ; Kessinger, Anne. / A randomized, double-blind trial of filgrastim (granulocyte colony- stimulating factor) versus placebo following allogeneic blood stem cell transplantation. In: Blood. 2000 ; Vol. 96, No. 1. pp. 80-85.
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abstract = "Blood stem cell transplantation (BSCT) results in rapid hematopoietic recovery in both the allogeneic and autologous transplant settings. Because of the large numbers of progenitor cells in mobilized blood, the administration of growth factors after transplantation may not provide further acceleration of hematopoietic recovery. A randomized, double-blind, placebo-controlled study was performed to determine the effects of filgrastim (granulocyte colony-stimulating factor; G-CSF) administration on hematopoietic recovery after allogeneic BSCT. Fifty-four patients with hematologic malignancies undergoing a related, HLA-matched allogeneic BSCT were randomly assigned to receive daily filgrastim at 10 μg/kg or placebo starting on the day of transplantation. A minimum of 3 x 106 CD34+ cells/kg in the allograft was required for transplantation. All patients received a standard preparative regimen and a standard regimen for the prevention of graft-versus-host disease (GVHD). The median time to achieve an absolute neutrophil count greater than 0.5 x 109/L was 11 days (range, 9-20 days) for patients who received filgrastim compared with 15 days (range, 10-22 days) for patients who received placebo (P = .0082). The median time to achieve a platelet count greater than 20 x 109/L was 13 days (range, 8-35 days) for patients who received filgrastim compared with 15.5 days (range, 8-42 days) for patients who received placebo (P = .79). There were no significant differences for red blood cell transfusion independence, the incidence of acute GVHD, or 100-day mortality between the groups. The administration of filgrastim appears to be a safe and effective supportive-care measure following allogeneic BSCT. (C) 2000 by The American Society of Hematology.",
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