A multi-institutional randomized study for the evaluation of ubenimex
(Bestatin) in the treatment of adult acute nonlymphocytic leukemia was
performed. One hundred and ninety-five patients were registered from
February 1988 to December 1990. Patients who had reached complete remi
ssion by one or two courses of remission induction chemotherapy were d
ivided into the ubenimex group or the control group by randomization.
Patients of the ubenimex group started to receive 30 mg ubenimex orall
y once a day when maintenance therapy began and continued as long as p
ossible. Remission duration and survival were analyzed based on the da
ta as of August 31, 1991. Remission duration of the ubenimex group was
superior to that of the control group (generalized Wilcoxon test: p =
0.0338). Fifty percent remission duration was 508 days in the ubenime
x group and 386 days in the control group. There has been no statistic
al difference in survival between the two groups as yet.