Symptoms and General Pathology

All Conditions

Neoplasms

Blood and Lymph Conditions

Rare Diseases

Syndrome

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Preleukemia

Myelodysplastic Syndromes

Neoplasms by Histologic Type

Hematologic Diseases

Bone Marrow Diseases

Precancerous Conditions

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Anti-Infective Agents

Antineoplastic Agents

All Drugs and Chemicals

Ammonium trichloro(dioxoethylene-O,O'-)tellurate

Adjuvants, Immunologic

Immunologic Factors

Protective Agents

Radiation-Protective Agents

Reverse Transcriptase Inhibitors

Enzyme Inhibitors

Antiviral Agents

In addition to induction chemotherapy AS101 will be given intravenously. The patient will also receive AS101 infusions during the time break till the next chemotherapy course, as long as the patient does not achieve complete remission and the platelet count is \<20,000/μl; ANC \<1000. AS101 will be administered likewise up to two consolidation or equivalent chemotherapy courses (re-induction or salvage in the event that no CR is achieved following first induction chemotherapy), i.e., total of three chemotherapy courses.

3 mg/m2 AS101 will be given intravenously (IV) three times per week.

AS101

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.

Safety and Efficacy Study of AS101 to Treat Elderly Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) Patients

Application of AS101 in Combination With Chemotherapy for Elderly Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)

BioMAS Ltd

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Safety and Efficacy Study of AS101 to Treat Elderly Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) Patients	NCT01010373	Acute Myeloid L... Myelodysplastic...	AS101	60 Years - 85 Years	BioMAS Ltd
Safety and Efficacy Study of AS101 to Treat Elderly Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) Patients	NCT01010373	Acute Myeloid L... Myelodysplastic...	AS101	60 Years - 85 Years	BioMAS Ltd

Spots Global Cancer Trial Database for primary acute myeloid leukemia (aml) and myelodysplastic syndrome (mds) induced aml.