Roquinimex (Linomide) vs placebo in AML after autologous bone marrow transplantation

Roquinimex, Linomide, a quinoline derivative with pleiotropic immunomodulat ory activity, has previously been shown to enhance natural killer (NK) cell number and activity after ABMT in patients with ARIL. In this study 278 AM L patients in remission were randomized to receive Roquinimex 0.2 mg/kg bod y weight or placebo twice weekly for 2 years following ABMT. Out of 139 pat ients in each group, 109 Roquinimex patients and 108 placebo patients were in their first CR, Median age at inclusion was 41 years for Roquinimex pati ents and 39 years for placebo patients. Twelve patients in each group had t heir marrow purged prior to reinfusion, Relapse and death were study endpoi nts, Surviving patients were followed for 2.6 to 6.9 years, The total numbe r of relapses was 60 in the Roquinimex group and 63 in the placebo group (n ot significant). Leukemia-free and overall survivals were similar in the tw o groups. Recovery of platelet counts was significantly delayed in the Roqu inimex group as compared to placebo, No other significant differences regar ding toxicity parameters were recorded. In conclusion, previous findings on NK cells could not be confirmed and the study showed no benefit for Roquin imex over placebo regarding relapse or survival following ABMT for AML in r emission.