- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01010373
Safety and Efficacy Study of AS101 to Treat Elderly Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) Patients
February 9, 2015 updated by: BioMAS Ltd
Application of AS101 in Combination With Chemotherapy for Elderly Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)
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.
Study Overview
Status
Suspended
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Anticipated)
12
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tel Hashomer, Israel
- Sheba Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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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3 mg/m2 AS101 will be given intravenously (IV) three times per week.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
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Continously during study and maximum 6 months from the beginning of the study.
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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To assess safety and tolerability of AS101.
Time Frame: Continously during study and maximum 6 months from the beginning of the study.
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Continously during study and maximum 6 months from the beginning of the study.
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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.
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Continously during study and maximum 6 months from the beginning of the study.
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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.
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Continously during study and maximum 6 months from the beginning of the study.
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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.
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Continously during study and maximum 6 months from the beginning of the study.
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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.
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Continously during study and maximum 6 months from the beginning of the study.
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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.
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Continously during study and maximum 6 months from the beginning of the study.
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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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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.
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Continously during study and maximum 6 months from the beginning of the study.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2015
Primary Completion (Anticipated)
January 1, 2016
Study Completion (Anticipated)
January 1, 2016
Study Registration Dates
First Submitted
November 9, 2009
First Submitted That Met QC Criteria
November 9, 2009
First Posted (Estimate)
November 10, 2009
Study Record Updates
Last Update Posted (Estimate)
February 10, 2015
Last Update Submitted That Met QC Criteria
February 9, 2015
Last Verified
February 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms by Histologic Type
- Neoplasms
- Disease
- Bone Marrow Diseases
- Hematologic Diseases
- Precancerous Conditions
- Syndrome
- Myelodysplastic Syndromes
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myeloid, Acute
- Preleukemia
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antineoplastic Agents
- Immunologic Factors
- Protective Agents
- Adjuvants, Immunologic
- Radiation-Protective Agents
- Ammonium trichloro(dioxoethylene-O,O'-)tellurate
Other Study ID Numbers
- #77REV00
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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