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Blood, Vol. 94 No. 11 (December 1), 1999:
pp. 3694-3701
A Randomized, Double-Blind, Placebo-Controlled Study With Pegylated
Recombinant Human Megakaryocyte Growth and Development Factor
(PEG-rHuMGDF) as an Adjunct to Chemotherapy for Adults With De Novo
Acute Myeloid Leukemia
Eric Archimbaud ,
Oliver G. Ottmann,
John A. Liu Yin,
Klaus Lechner,
Herve Dombret,
Miguel A. Sanz,
Gerhard Heil,
Pierre Fenaux,
Wolfram Brugger,
Alan Barge,
Caroline O'Brien-Ewen,
James Matcham, and
Dieter Hoelzer
From the Hôpital Edouard Herriot, Lyon, France; University of
Frankfurt, Frankfurt, Germany; Manchester Royal Infirmary, Manchester,
UK; University of Vienna, Vienna, Austria; Hôpital Saint-Louis,
Paris, France; Hospital Universitario Le Fe, Valencia, Spain; Hannover
Medical School, Hannover, Germany; CHU Lille, France; University of
Tübingen, Tübingen, Germany; and Amgen Ltd, Cambridge,
UK.
To determine the safety, biologic, and clinical benefits of
pegylated recombinant human megakaryocyte growth and
development factor (PEG-rHuMGDF; Amgen, Thousand Oaks, CA) after
myelosuppressive chemotherapy in acute myeloid leukemia (AML), 108 adult patients with de novo AML were randomized to receive either
PEG-rHuMGDF (2.5 µg/kg/d or 5 µg/kg/d) for up to 21 doses (group
A), a single dose of 2.5 µg/kg PEG-rHuMGDF, 7 daily doses of 2.5 µg/kg PEG-rHuMGDF (group B), or placebo. The greatest biologic
activity was seen in group A with a median peak platelet count of 1,084 × 109/L, occurring at a median 9 days after the last dose
of study drug, compared with 517 × 109/L and 390 × 109/L in group B and placebo group, respectively.
Thrombocytosis (platelets >1,000 × 109/L) was seen at
rates of 52%, 8%, and 9% in groups A, B, and placebo, respectively,
but were not associated with any adverse event. There was no effect on
median time to transfusion independent platelet recovery ( 20 × 109/L). The median time to neutrophil recovery
(500/µL) and red blood cell transfusion requirements were similar
in all groups, and there was no apparent stimulation of leukemia.
PEG-rHuMGDF was biologically active and well tolerated. Further
investigation of dose and scheduling is required, specifically earlier
dosing before and during chemotherapy.
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