Acute Myeloid LeukemiaPhase 2NCT01010373
Safety and Efficacy Study of AS101 to Treat Elderly Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) Patients
A Phase 2 study testing AS101 in people with Acute Myeloid Leukemia and Myelodysplastic Syndrome, run by BioMAS Ltd at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Acute Myeloid Leukemia, Myelodysplastic Syndrome
- What is being tested?
- AS101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2015to Jan 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Myeloid Leukemia, Myelodysplastic Syndrome
- Being tested
- AS101
- Keywords
- Primary Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) induced AML.
- Medical subject headings
- Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AS101Drug
3 mg/m2 AS101 will be given intravenously (IV) three times per week.
| Study group | Role | What they receive |
|---|---|---|
| AS101 infusions | Experimental | 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. Receives: Drug: AS101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time (days) to reach platelet counts ≥20,000/µl after first induction course and post-remission chemotherapy courses.
Measured: Continously during study and maximum 6 months from the beginning of the study.
Secondary outcomes (8)
To assess safety and tolerability of AS101.
Measured: Continously during study and maximum 6 months from the beginning of the study.
Reduction in bone marrow blasts from baseline throughout the study period.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Continously during study and maximum 6 months from the beginning of the study.
To evaluate the number of platelet transfusions through the study period.
Measured: 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.
Measured: 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.
Measured: Continously during study and maximum 6 months from the beginning of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2009 (estimated)
- Study startJan 2015
- Primary completionJan 2016 (estimated)
- Study completionJan 2016 (estimated)
Why it stopped: The sponsor is currently focusing on different indications
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioMAS Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01010373
- Sponsor's protocol ID
- #77REV00
- Status last verified
- Feb 2015
- First submitted
- 9 Nov 2009
- Last updated
- 10 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of AS101 in Combination With Chemotherapy for Elderly Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)
- ClinicalTrials.gov ID
- NCT01010373
- Acronym / sponsor ID
- #77REV00
- Conditions
- Acute Myeloid Leukemia, Myelodysplastic Syndrome
- Keywords
- Primary Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) induced AML.
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: The sponsor is currently focusing on different indications
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- BioMAS LtdIndustry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 10 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AS101 infusions | Experimental | Drug: AS101In 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. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AS1013 mg/m2 AS101 will be given intravenously (IV) three times per week. | Drug | AS101 infusions |
Primary outcome
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.
8 secondary outcomes
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AS101 in people with Acute Myeloid Leukemia and Myelodysplastic Syndrome, run by BioMAS Ltd at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 10 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2015.