Personalized leukemia vaccine aims to outsmart relapse

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Screening: * Patients with AML at initial diagnosis or at first relapse * 18 years of age or older * ECOG Performance Status 0-2 * Life expectancy of greater than 9 weeks * Laboratory values within limits outlined in the protocol * Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation Prior to Cell Collections for Dendritic Cell Generation: * Patients must have obtained complete remission with chemotherapy defined by the absence of circulating blasts, and less then 5% blasts on bone marrow examination following hematopoietic recovery * Resolution of all chemotherapy related Grade III-IV toxicity as per CTC criteria 4.0 * Laboratory values as outlined in the protocol * For patients with evidence of minimal residual disease prior to vaccination, assessment of minimal residual disease status by cytogenetics or FISH will be followed post vaccination Prior to Post-Chemotherapy Immunotherapy: * Resolution of all chemotherapy related grade III-IV toxicity * Laboratory values as outlined in the protocol * At least 2 doses of fusion vaccine produced Exclusion Criteria: Screening: * Active or history of autoimmune disorders/conditions including Type 1 diabetes. Type II diabetes, vitiligo or stable hyperthyroidism will not be considered exclusion criteria * HIV positive * Significant cardiac disease characterized by symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmia * Pregnant women * Individuals with a history of a different malignancy are ineligible except for circumstances outlined in the protocol document Prior to Cell Collection for Dendritic Cell Generation: * Serious intercurrent illness such as infection requiring IV antibiotics, or significant cardiac disease characterized by significant arrhythmia, ischemic coronary disease or congestive heart failure * Patients who choose to proceed with allogeneic or autologous transplant at the time of remission will not be vaccinated and will come off study