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- Title
Recombinant Human Non-glycosylated Granulocyte-macrophage Colony-stimulating Factor in Allogeneic Bone Marrow Transplantation: Double-blind Placebo-controlled Phase III Clinical Trial.
- Authors
Hiraoka, Akira; Masaoka, Tohru; Mizoguchi, Hideaki; Asano, Shigetaka; Kodera, Yoshihisa; Kitamura, Kiyoshi; Takaku, Fumimaro; Komemushi, Sadao
- Abstract
In a randomized double-blind placebo-controlled phase III clinical trial, the effects of a non-glycosylated recombinant human granulocyte-macrophage colony-stimulating factor (CSF 39-300) were investigated in patients who had received allogeneic bone marrow transplantation. CSF 39-300 was administered at a daily dose of 10 μg/kg (maximum dose, 300 μg/body) via three-hour intravenous infusions from days 1 to 21 following reinfusion of the marrow. Twenty-eight patients received CSF 39–300 and 25, placebo. The median number of days to recovery for leucocytes (≥1000/mm3), neutrophils (≥500/mm3), lymphocytes (≥300/mm3) and reticulocytes (≥20%0) were significantly shortened (16 vs 20, 17 vs 21 and 22 vs 28, respectively) with CSF 39-300. The duration of stay in laminar-air-flow room after transplantation was also significantly shortened in the CSF 39-300 group (21 vs 30 days). There was no significant difference in the incidence of acute or chronic graft-versus-host disease between the two groups. A follow-up during the year after transplantation revealed there to be no significant difference in either survival rate or leukemia relapse rate between-the two groups. CSF 39-300 is therefore considered useful after allogeneic bone marrow transplantation, especially in the early period.
- Publication
Japanese Journal of Clinical Oncology, 1994, Vol 24, Issue 4, p205
- ISSN
0368-2811
- Publication type
Article