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

• Status: Suspended
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BioMAS Ltd
• Treatments: Ammonium trichloro(dioxoethylene-O,O'-)tellurate

Criteria

Inclusion Criteria:

• Confirmed diagnosis of primary AML or AML transformed myelodysplastic syndrome (MDS) with FAB classification other than M3 as proven by bone marrow aspiration.

• Age ≥60 years.

• ECOG performance status of 0-2 (Karnofsky >60%).

• Adequate renal functions: Serum Creatinine < 2 times the upper limit of normal (ULN).

• Adequate hepatic function: serum AST and ALT ≤ 3 x ULN.

• Patients with reproductive potential must use an effective contraceptive method through the study. Patients must receive contraceptive and/or fertility counseling prior to entering the study, i.e., information on sperm banking, etc.

Exclusion Criteria:

• Patients receiving any other investigational agents.

• Symptomatic CNS involvement.

• History of pancreatitis or active alcohol abuse.

• Histologic diagnosis of FAB M3 AML.

• Life expectancy of less than 1 month.

• Patient receives Myelotarg (ozogamicin gemtuzumab).

• Use of hematopoietic growth factors such as G-CSF within 1 week prior to treatment initiation.

• Pregnant or lactating females.

• Patient has known human immunodeficiency virus (HIV) infection or known HIV-related malignancy; Patient has active hepatitis A, B or C infection.

• Active, uncontrolled, systemic infection considered opportunistic, life threatening, or of clinical significance at the time of treatment, or any severe concurrent disease which, in the opinion of the investigator, would make the patient inappropriate for trial entry.

• The patient has had congestive heart failure - New York Heart Association (CHF-NYHA) grade II or higher, and/or myocardial infarction within the last 12 months, or any cardiac disorder which, in the opinion of the Investigator, could put the patient at risk of clinically relevant arrhythmia.