Recombinant human non-glycosylated granulocyte-macrophage colony-stimulating factor in allogeneic bone marrow transplantation: double-blind placebo-controlled phase III clinical trial.
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 micrograms/kg (maximum dose, 300 micrograms/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 (> or = 1000/mm3), neutrophils (> or = 500/mm3), lymphocytes (> or = 300/mm3) and reticulocytes (> or = 20/1000) 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.
Hiraoka
A
A
Fifth Department of Internal Medicine, Center for Adult Disease, Osaka.
Masaoka
T
T
Mizoguchi
H
H
Asano
S
S
Kodera
Y
Y
Kitamura
K
K
Takaku
F
F
Komemushi
S
S
D000293:Adolescent; D000328:Adult; D016026:Bone Marrow Transplantation; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D016178:Granulocyte-Macrophage Colony-Stimulating Factor / Q000008:administration & dosage*; D006801:Humans; D007262:Infusions, Intravenous; D007958:Leukocyte Count; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins / Q000008:administration & dosage
D011994:Recombinant Proteins; D016178:Granulocyte-Macrophage Colony-Stimulating Factor