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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
- Source :
- Blood, r-IIS La Fe. Repositorio Institucional de Producción Científica del Instituto de Investigación Sanitaria La Fe, instname, Europe PubMed Central
- Publication Year :
- 1999
- Publisher :
- American Society of Hematology, 1999.
-
Abstract
- 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 mu g/kg/d or 5 mu g/kg/d) for up to 21 doses (group A), a single dose of 2.5 mu g/kg PEG-rHuMGDF, 7 daily doses of 2.5 mu g/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 x 10(9)/L, occurring at a median 9 days after the last dose of study drug, compared with 517 x 10(9)/L and 396 x 10(9)/L in group B and placebo group, respectively. Thrombocytosis (platelets >1,000 x 10(9)/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 (greater than or equal to 20 x 10(9)/L). The median time to neutrophil recovery (greater than or equal to 500/mu L) 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. (C) 1999 by The American Society of Hematology.
- Subjects :
- Adult
Male
medicine.medical_specialty
medicine.medical_treatment
Immunology
REMISSION INDUCTION
INDUCED THROMBOCYTOPENIA
Placebo-controlled study
Placebo
Biochemistry
Gastroenterology
Polyethylene Glycols
Double-Blind Method
Internal medicine
Antineoplastic Combined Chemotherapy Protocols
medicine
Humans
Thrombopoietin
Aged
Chemotherapy
Myelosuppressive Chemotherapy
ACUTE MYELOGENOUS LEUKEMIA
C-MPL LIGAND
Thrombocytosis
business.industry
NONHUMAN-PRIMATES
Myeloid leukemia
BONE-MARROW TRANSPLANTATION
IN-VITRO
Cell Biology
Hematology
Middle Aged
COLONY-STIMULATING FACTOR
medicine.disease
PHASE-III
Recombinant Proteins
Leukemia
Treatment Outcome
Endocrinology
Leukemia, Myeloid
Acute Disease
Female
business
RECEPTOR MPL
Subjects
Details
- ISSN :
- 15280020 and 00064971
- Volume :
- 94
- Database :
- OpenAIRE
- Journal :
- Blood
- Accession number :
- edsair.doi.dedup.....54c834dbd5e7392efa2454e14bf62b12