The majority of AML patients in first complete Remission (CR) do relapse despite the current consolidation therapy. Leukemic stem cells that are dormant in the bone marrow are presumed to be a major reason for AML relapse. Allogenic stem cell transplantation is an option only for a minority of AML patients in 1st CR. BL-8040 is a novel CXCR4 inhibitor that has a dual mechanism of action: inducing mobilization of leukemic blasts from the bone marrow which enhances cytotoxic effects of chemotherapy and has direct antileukemic, pro-apoptotic properties. The treatment with BL-8040 in combination with consolidation therapy (standard consolidation with high-dose cytarabine) should improve the efficacy of the consolidation therapy resulting in longer lasting remissions.
This study evaluates the addition of BL-8040 to the standard consolidation therapy with cytarabine in the treatment of acute myeloid leukemia (AML) in adults. Half of participants will receive BL-8040 and cytarabine in combination, while the other half will receive placebo and cytarabine.