Application of AS101 in Combination With Chemotherapy for Elderly Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)
AML patients frequently develop cytopenia, which can result in life-threatening bleeding and
infections. Despite the administration of prophylactic platelet transfusions, these patients
remain at risk of clinically significant hemorrhage. There is a growing need for new,
innovative strategies, because the outcome for AML patients, particularly for the older
ones, has not substantially changed in the last three decades. Thus, novel compounds to
target the tumor cell's resistance to chemotherapeutic agents are essential for the
improvement of patients' prognoses. AS101 is a non-toxic, organic, tellurium-based small
compound with immunomodulating properties which have previously shown bone marrow sparing
effect. In addition in preclinical studies AS101 has shown synergistic effect with several
cytotoxic drugs. This study will investigate the safety and efficacy of AS101 formulation in
combination with the standard therapy for newly diagnosed elderly AML and AML transformed
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Time (days) to reach platelet counts ≥20,000/µl after first induction course and post-remission chemotherapy courses.
Continously during study and maximum 6 months from the beginning of the study.
Israel: Ministry of Health