The purpose of this study is to determine whether addition of AS101 to the standard chemotherapy regimen is effective in the treatment of newly diagnosed elderly (≥60) AML patients and AML transformed myelodysplastic syndrome (MDS) patients.
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 MDS patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
3 mg/m2 AS101 will be given intravenously (IV) three times per week.
Sheba Medical Center
Tel Litwinsky, Israel
Time (days) to reach platelet counts ≥20,000/µl after first induction course and post-remission chemotherapy courses.
Time frame: Continously during study and maximum 6 months from the beginning of the study.
To assess safety and tolerability of AS101.
Time frame: Continously during study and maximum 6 months from the beginning of the study.
Reduction in bone marrow blasts from baseline throughout the study period.
Time frame: Continously during study and maximum 6 months from the beginning of the study.
Time (days) to reach platelets counts ≥50,000/µl after first induction course and subsequent post-remission chemotherapy courses.
Time frame: Continously during study and maximum 6 months from the beginning of the study.
Time (days) to reach platelets counts ≥100,000/µl after first induction course and subsequent post-remission chemotherapy courses.
Time frame: Continously during study and maximum 6 months from the beginning of the study.
Time (days) to reach the maximum platelets counts after chemotherapy courses throughout the study period.
Time frame: Continously during study and maximum 6 months from the beginning of the study.
To evaluate the number of platelet transfusions through the study period.
Time frame: Continously during study and maximum 6 months from the beginning of the study.
To measure the incidence and severity of bleeding events using the World Health Organization (WHO) Bleeding Scale, during the treatment and follow-up periods.
Time frame: Continously during study and maximum 6 months from the beginning of the study.
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To assess a correlation between VLA-4 expressions level of leukemia blasts in vitro and the response to treatment in terms of blasts percent.
Time frame: Continously during study and maximum 6 months from the beginning of the study.