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

Phase 2
60 Years
85 Years
Not Enrolling
Acute Myeloid Leukemia, Myelodysplastic Syndrome

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Trial Information

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
MDS patients.

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

- 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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time (days) to reach platelet counts ≥20,000/µl after first induction course and post-remission chemotherapy courses.

Outcome Time Frame:

Continously during study and maximum 6 months from the beginning of the study.

Safety Issue:



Israel: Ministry of Health

Study ID:




Start Date:

January 2012

Completion Date:

January 2014

Related Keywords:

  • Acute Myeloid Leukemia
  • Myelodysplastic Syndrome
  • Primary Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) induced AML.
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Myelodysplastic Syndromes
  • Preleukemia