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A Phase 3, Randomized, Placebo-controlled Trial of Filgrastim in Patients with Haematological Malignancies Undergoing Matched-related Allogeneic Bone Marrow Transplantation
INTRODUCTION: Recombinant granulocyte colony-stimulating factor (G-CSF) may aid engraftment post high-dose chemo-/radiotherapy in patients with haematological malignancies undergoing allogeneic bone marrow transplantation (BMT); however, the effects of G-CSF on graft-versus-host disease (GvHD), rela...
Autores principales: | , , , , , , |
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Formato: | Texto |
Lenguaje: | English |
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Blackwell Publishing Ltd
2008
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2710993/ https://www.ncbi.nlm.nih.gov/pubmed/19639030 http://dx.doi.org/10.1111/j.1753-5174.2008.00013.x |
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author | Ernst, Peter Bacigalupo, Andrea Ringdén, Olle Ruutu, Tapani Kolb, Hans J Lawrinson, Susan Skacel, Tomas |
author_facet | Ernst, Peter Bacigalupo, Andrea Ringdén, Olle Ruutu, Tapani Kolb, Hans J Lawrinson, Susan Skacel, Tomas |
author_sort | Ernst, Peter |
collection | PubMed |
description | INTRODUCTION: Recombinant granulocyte colony-stimulating factor (G-CSF) may aid engraftment post high-dose chemo-/radiotherapy in patients with haematological malignancies undergoing allogeneic bone marrow transplantation (BMT); however, the effects of G-CSF on graft-versus-host disease (GvHD), relapse, and survival are not well defined. METHODS: In this double-blind, randomized, placebo-controlled, multicentre, phase 3 study, the effects of the G-CSF Filgrastim on neutrophil and platelet recovery, and on clinical outcomes were evaluated. Patients (12–55 years) receiving an allogeneic BMT for a haematological malignancy were randomized to receive Filgrastim 5 µg/kg or placebo. Study treatment was continued until patients achieved an absolute neutrophil count (ANC) ≥0.5 × 10(9)/L, or until day 42. RESULTS: Fifty-one patients (Filgrastim, N = 25; placebo, N = 26) were evaluable. Patients treated with Filgrastim had significantly faster engraftment with ANC ≥0.5 × 10(9)/L being achieved after a median (range) of 15.0 (1.0–22.0) days vs. 19.0 (15.0–28.0) days for placebo (P< 0.0001). The incidence of GvHD was comparable for both groups. During the limited follow-up (2 years), Filgrastim had no adverse effect on mortality and possibly reduced the rate of relapse. |
format | Text |
id | pubmed-2710993 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2008 |
publisher | Blackwell Publishing Ltd |
record_format | MEDLINE/PubMed |
spelling | pubmed-27109932009-07-27 A Phase 3, Randomized, Placebo-controlled Trial of Filgrastim in Patients with Haematological Malignancies Undergoing Matched-related Allogeneic Bone Marrow Transplantation Ernst, Peter Bacigalupo, Andrea Ringdén, Olle Ruutu, Tapani Kolb, Hans J Lawrinson, Susan Skacel, Tomas Arch Drug Inf Original Articles INTRODUCTION: Recombinant granulocyte colony-stimulating factor (G-CSF) may aid engraftment post high-dose chemo-/radiotherapy in patients with haematological malignancies undergoing allogeneic bone marrow transplantation (BMT); however, the effects of G-CSF on graft-versus-host disease (GvHD), relapse, and survival are not well defined. METHODS: In this double-blind, randomized, placebo-controlled, multicentre, phase 3 study, the effects of the G-CSF Filgrastim on neutrophil and platelet recovery, and on clinical outcomes were evaluated. Patients (12–55 years) receiving an allogeneic BMT for a haematological malignancy were randomized to receive Filgrastim 5 µg/kg or placebo. Study treatment was continued until patients achieved an absolute neutrophil count (ANC) ≥0.5 × 10(9)/L, or until day 42. RESULTS: Fifty-one patients (Filgrastim, N = 25; placebo, N = 26) were evaluable. Patients treated with Filgrastim had significantly faster engraftment with ANC ≥0.5 × 10(9)/L being achieved after a median (range) of 15.0 (1.0–22.0) days vs. 19.0 (15.0–28.0) days for placebo (P< 0.0001). The incidence of GvHD was comparable for both groups. During the limited follow-up (2 years), Filgrastim had no adverse effect on mortality and possibly reduced the rate of relapse. Blackwell Publishing Ltd 2008-12 /pmc/articles/PMC2710993/ /pubmed/19639030 http://dx.doi.org/10.1111/j.1753-5174.2008.00013.x Text en © 2008, Archives of Drug Information http://creativecommons.org/licenses/by/2.5/ Re-use of this article is permitted in accordance with the Creative Commons Deed, Attribution 2.5, which does not permit commercial exploitation. |
spellingShingle | Original Articles Ernst, Peter Bacigalupo, Andrea Ringdén, Olle Ruutu, Tapani Kolb, Hans J Lawrinson, Susan Skacel, Tomas A Phase 3, Randomized, Placebo-controlled Trial of Filgrastim in Patients with Haematological Malignancies Undergoing Matched-related Allogeneic Bone Marrow Transplantation |
title | A Phase 3, Randomized, Placebo-controlled Trial of Filgrastim in Patients with Haematological Malignancies Undergoing Matched-related Allogeneic Bone Marrow Transplantation |
title_full | A Phase 3, Randomized, Placebo-controlled Trial of Filgrastim in Patients with Haematological Malignancies Undergoing Matched-related Allogeneic Bone Marrow Transplantation |
title_fullStr | A Phase 3, Randomized, Placebo-controlled Trial of Filgrastim in Patients with Haematological Malignancies Undergoing Matched-related Allogeneic Bone Marrow Transplantation |
title_full_unstemmed | A Phase 3, Randomized, Placebo-controlled Trial of Filgrastim in Patients with Haematological Malignancies Undergoing Matched-related Allogeneic Bone Marrow Transplantation |
title_short | A Phase 3, Randomized, Placebo-controlled Trial of Filgrastim in Patients with Haematological Malignancies Undergoing Matched-related Allogeneic Bone Marrow Transplantation |
title_sort | phase 3, randomized, placebo-controlled trial of filgrastim in patients with haematological malignancies undergoing matched-related allogeneic bone marrow transplantation |
topic | Original Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2710993/ https://www.ncbi.nlm.nih.gov/pubmed/19639030 http://dx.doi.org/10.1111/j.1753-5174.2008.00013.x |
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