AIM: To evaluate the validity of the colony forming unit-granulocyte macrophage (CFU-GM) assay for predicting relapse in patients with acute myeloid leukaemia (AML). METHODS: The study population comprised 32 patients with AML in remission, followed for a median of 18 months. A mean of four studies was carried out per patient. Three patterns of in vitro growth based on the number of CFU-GM in normal bone marrow were defined: 1 = normal (normal number of CFU-GM and a cluster:colony ratio < 2); 2 = hypoplastic (low number of CFU-GM and a cluster:colony ratio < 2); 3 = anomalous (low or normal number of CFU-GM and a cluster:colony ratio > 2). RESULTS: Eleven patients relapsed, all of whom had previously displayed an abnormal CFU-GM pattern: anomalous in nine and hypoplastic in two. The remaining 25 patients were in complete remission at the time of writing, 16 of whom had a normal growth pattern. The other nine had anomalous (eight patients) or hypoplastic (one patient) growth. The latter may be false positive results. The in vitro growth pattern was not constant during follow up analysis. All 15 patients in whom the growth pattern switched from abnormal to normal remain in complete remission. By contrast, of the five cases in whom the pattern changed from normal to abnormal, three have relapsed and the other two had other indicators of relapse. The growth pattern remained unchanged in the remaining 16 patients. CONCLUSION: The present data show that the sequential investigation of the CFU-GM growth pattern may be of value in predicting relapse in patients with AML.