Safety and Efficacy Study of AS101 to Treat Elderly Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) Patients
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ClinicalTrials.gov Identifier: NCT01010373 |
Recruitment Status :
Suspended
(The sponsor is currently focusing on different indications)
First Posted : November 10, 2009
Last Update Posted : February 10, 2015
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Condition or disease | Intervention/treatment | Phase |
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Acute Myeloid Leukemia Myelodysplastic Syndrome | Drug: AS101 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 12 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Application of AS101 in Combination With Chemotherapy for Elderly Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) |
Study Start Date : | January 2015 |
Estimated Primary Completion Date : | January 2016 |
Estimated Study Completion Date : | January 2016 |

Arm | Intervention/treatment |
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Experimental: AS101 infusions
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.
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Drug: AS101
3 mg/m2 AS101 will be given intravenously (IV) three times per week. |
- 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. ]
- 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. ]

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Ages Eligible for Study: | 60 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01010373
Israel | |
Sheba Medical Center | |
Tel Hashomer, Israel |
Responsible Party: | BioMAS Ltd |
ClinicalTrials.gov Identifier: | NCT01010373 |
Other Study ID Numbers: |
#77REV00 |
First Posted: | November 10, 2009 Key Record Dates |
Last Update Posted: | February 10, 2015 |
Last Verified: | February 2015 |
Primary Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) induced AML. |
Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Preleukemia Myelodysplastic Syndromes Syndrome Disease Pathologic Processes Neoplasms by Histologic Type Neoplasms Bone Marrow Diseases |
Hematologic Diseases Precancerous Conditions Ammonium trichloro(dioxoethylene-O,O'-)tellurate Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents Antiviral Agents Anti-Infective Agents Radiation-Protective Agents Protective Agents |