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

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Abstract
Summary 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‐CSP treated and 59 placebo control patients. HM‐CSF was administered at a daily dose of 2 ± 105 units/kg from day 1 to day 14 after RMT. Significant differences between hM‐CSF and control patients were found in the recovery time to greater than 0. 5 ± 109 granulocytes/1 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 non‐lymphocytic, 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.

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