Chemoimmunotherapy with levamisole in acute lymphoblastic leukemia

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Abstract
Patients with acute lymphoblastic leukemia (ALL) who were in two consecutive protocols and in complete remission (CR) with maintenance therapy, were randomized to receive or not receive levamisole. A total of 15 of 55 low-risk patients of protocol 10-LLA-72 with levamisole had relapses, compared with 25 of 54 not receiving levamisole; 67 and 49%, respectively, remain in CR at 48 months (P < 0.025). In protocol 1-LLA-76, 14 of 91 low-risk patients on levamisole and 25 of 93 patients not receiving levamisole had relapses; 78 and 61%, respectively, remain in CR at 36 months (P < 0.05). Seventeen of 39 high-risk patients (children with a leukocyte count higher than 50,000 and adults) receiving levamisole had relapses compared with 37 of 61 not on levamisole. The DNCB skin test shows at 18 and 24 months a 74 and 85% positivity in the levamisole group vs. a 38 and 35% positivity in the control group (P< 0.025). We conclude that levamisole prolongs the duration of CR and survival in low-risk patients with ALL.