Double-blind test of human urinary macrophage colony-stimulating factor for allogeneic and syngeneic bone marrow transplantation: effectiveness of treatment and 2-year follow-up for relapse of leukaemia.
A randomized, double-blind placebo-controlled phase III clinical trial was performed to study the effects of human urinary macrophage colony-stimulating factor (hM-CSF) after allogeneic and syngeneic bone marrow transplantation (BMT) in 60 hM-CSF treated and 59 placebo control patients. HM-CSF was administered at a daily dose of 2 x 10(5) units/kg from day 1 to day 14 after BMT. Significant differences between hM-CSF and control patient were found in the recovery time to greater than 0.5 x 10(9) granulocytes/l and the survival rate during the initial 120 d without retransplantation. There was no difference in the incidence or grade of graft-versus-host disease (GVHD). There was no difference in the rate of leukaemic relapse at 24-36 months after BMT in patients with acute lymphocytic, acute nonlymphocytic, or monocytic leukaemia. The results of this trial show that human M-CSF improves the outcome of BMT without any influence on the occurrence of leukaemic relapse or GVHD.
Masaoka
T
T
5th Department of Internal Medicine, Center for Adult Diseases, Osaka, Japan.
Shibata
H
H
Ohno
R
R
Katoh
S
S
Harada
M
M
Motoyoshi
K
K
Takaku
F
F
Sakuma
A
A
D000293:Adolescent; D000328:Adult; D016026:Bone Marrow Transplantation; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006086:Graft vs Host Disease / Q000209:etiology; D006801:Humans; D007938:Leukemia / Q000401:mortality / Q000628:therapy*; D007958:Leukocyte Count; D016173:Macrophage Colony-Stimulating Factor / Q000627:therapeutic use* / Q000652:urine; D008297:Male; D008875:Middle Aged
D016173:Macrophage Colony-Stimulating Factor