Please use this identifier to cite or link to this item: https://hdl.handle.net/2440/9255
Citations
Scopus Web of ScienceĀ® Altmetric
?
?
Type: Journal article
Title: Prior and concurrent administration of recombinant human megakaryocyte growth and development factor in patients receiving consolidation chemotherapy for de novo acute myeloid leukemia-a randomized, placebo-controlled, double-blind safety and efficac
Author: Geissler, K.
Liu Yin, J.
Ganser, A.
Sanz, M.
Szer, J.
Raghavachar, A.
Hoelzer, D.
Martinez, C.
Taylor, K.
Kanz, L.
To, L.
Archimbaud, E.
Citation: Annals of Hematology, 2003; 82(11):677-683
Publisher: Springer
Issue Date: 2003
ISSN: 0939-5555
1432-0584
Abstract: Pegylated recombinant human megakaryocyte growth and development factor (PEG-rHuMGDF) administered after acute myeloid leukemia (AML) chemotherapy (CT) failed to shorten the time of transfusion-dependent thrombocytopenia in a previous study. In this multicenter, randomized, placebo-controlled, double-blind study we determined the effect of administration of PEG-rHuMGDF prior to CT and of administration prior, concurrent, and 1 day post CT on platelet recovery and transfusion requirements in patients receiving consolidation CT for de novo AML. Patients were randomized to receive either 30 microk/kg PEG-rHuMGDF as a single dose on day -6 ( n=37), placebo as a single dose on day -6 ( n=9), 30 microk/kg PEG-rHuMGDF administered on day -6 followed by 10 microg/kg on days -5 to day 6 (through CT and including the day after CT, n=35), or placebo administered on day -6 to day 6 ( n=9). The median times to transfusion-independent platelet recovery to >20x10(9)/l were 24.5 and 24.0 days in the PEG-rHuMGDF day -6 group and PEG-rHuMGDF day -6 to 6, respectively, compared to 21.0 days in the placebo group. There were no significant differences in the number of days of platelet transfusions between either PEG-rHuMGDF schedule or placebo. The PEG-rHuMGDF day -6 to 6 group had a delayed absolute neutrophil count (ANC) recovery compared to either placebo or PEG-rHuMGDF day -6 treated patients. Thus, alteration of the scheduling of PEG-rHuMGDF in terms of earlier dosing before and during chemotherapy did not improve platelet recovery but rather delayed hematopoietic reconstitution. Although unexpected, these observations may be of major relevance for the design of future clinical trials with recombinant thrombopoietins.
Keywords: Blood Platelets
Neutrophils
Humans
Thrombosis
Polyethylene Glycols
Thrombopoietin
Recombinant Proteins
Antineoplastic Combined Chemotherapy Protocols
Placebos
Leukocyte Count
Blood Component Transfusion
Double-Blind Method
Adult
Aged
Aged, 80 and over
Middle Aged
Female
Male
Leukemia, Myeloid, Acute
DOI: 10.1007/s00277-003-0737-7
Appears in Collections:Aurora harvest
Medicine publications

Files in This Item:
There are no files associated with this item.


Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.