Clinical trials in vaccination with leukemia associated antigens in acute myelogenous leukemia.

Vaccination with purified leukemia associated antigens (LAA) was performed in sixty adult patients with acute myelogenous leukemia (AML) who were admitted to Medical City, Yermok Hospital, Alshaab Hospital, Altefelalarabie Hospital, Basrah Hospital, Mosul Hospital, Althawra Hospital and Samaon Hospital. LAA were prepared from leukemic cells, using hypotonic lysis and low frequency sonication, followed by discontinuous polyacrylamide gel electrophoresis or column chromatography. Five doses were given intradermally, after discontinuation of the maintenance therapy. Clinical and immunological studies were done prevaccination and used to evaluate the effect of this vaccine. The patients were randomized into two groups: one group included 32 patients who received LAA alone and the other group included 28 patients who received LAA with BCG-cell wall skeleton as an adjuvant. Control groups of patients were also randomized into two subgroups: one subgroup included 30 patients who did not receive any kind of immunotherapy, the other subgroup included 30 patients who received BCG-cell wall skeleton only. All the LAA vaccinated groups showed increased blastogenic response to LAA most pronounced on day 22 and afterwards. There was increased response to non-specific mitogens after vaccination, especially after the 63rd day. All the vaccinated groups showed increased skin reactivity to LAA after vaccination. Fifty-seven of these patients had an initial weak reaction but it became more marked after vaccination. There was a correlation between the blastogenic responses and skin test reactivity to the clinical course. All the nonvaccinated group and those who were given BCG-cell wall skeleton alone died within 9 weeks (range 7--11 weeks) after discontinued chemotherapy making the survival range from 23--40 weeks (median of 29 weeks), in contrast all the vaccinated groups who received LAA alone or in combination with three BCG-cell wall skeleton doses are in complete unmaintained remission ranging in survival from 58 weeks to 74 weeks (median value is 63 weeks).