Donor-specific cytotoxic T cell activity was measured over a period of 5 years after transplantation using the cell-mediated lympholysis (CML) test in 124 recipients of unrelated kidney allografts who received conventional immunosuppressive therapy consisting of azathioprine and prednisone. Since patients with a functioning transplant frequently display donor-specific CML non-responsiveness in vitro, we addressed the question of whether the CML status has a predictive value regarding the graft prognosis at any time interval until 5 years posttransplantation. From log-rank type analyses we conclude that the estimated relative risk calculated over the whole follow-up period of a CML-responder in the category of transplant rejectors is 1.25 with 95% confidence bounds between 0.94 and 1.65. Measurements of CML responder status during follow-up seem to have only limited prognostic value, although the relative risk is borderline significant when the analysis is restricted to the period between 2 weeks and 6 months posttransplantation.