A phase-I clinical trial of active immunotherapy for acute leukemia using inactivated autologous leukemia cells mixed with IL-2, GM-CSF, and IL-6

We evaluated the efficacy and toxicity of vaccination in 29 patients with relapsed or refractory acute leukemia using inactivated autologous leukemia cells combined with interleukin-2 (IL-2), granulocyte-macrophage colony-stimulating factor (GM-CSF), and IL-6. MHC-I, MHC-II, and B7-1 expression status on the surface of leukemia cells and the cytokine profile of IFN-γ and IL-10 in serum before and after vaccination was detected. Results: Five achieved a complete remission (CR) and six a partial remission (PR) in this vaccination procedure. Adverse effects were erythema, swelling erosion, and even ulcers at vaccination sites and low grade fever during the first three days of vaccination. No other significant side effects were observed. The expression of MHC-I and MHC-II on leukemia cells was 100% and 90% positive, respectively. B7-1 was exclusively expressed on some cases of M4 and M5. The efficacy of the vaccine was statistically associated with the expression status of B7-1 on leukemia cells (P < 0.01). The serum level of IL-10 reduced significantly in the five patients who achieved complete remission (CR) after vaccination as compared with when they were originally diagnosed (P < 0.01). Conclusion: We presented here a promising immunotherapy in the treatment of acute leukemia, especially for F.A.B. M5.