Acute Myeloid LeukemiaPhase 2NCT01034410
A Study of AS1411 Combined With Cytarabine in the Treatment of Patients With Primary Refractory or Relapsed Acute Myeloid Leukemia
A Phase 2 study testing AS1411 and Cytarabine in people with Acute Myeloid Leukemia, run by Antisoma Research at 14 sites in 4 countries.
Trial summary
This is an open label randomized controlled phase II study of AS1411 combined with Cytarabine in the treatment of patients with primary refractory or relapsed acute myeloid leukemia. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- AS1411 and Cytarabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 14 sitesin 4 countries
- Study dates
- Jan 2010to Jan 2011
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of AML as defined by the World Health Organization (WHO) classification (Vardiman 2009)
- Primary refractory AML (defined as a failure to achieve a CR or CRi after therapy with curative intent) or AML in first relapse
- ECOG Performance status 0, 1 or 2
- Age > 18 and < 70 years
- For patients presenting with primary refractory AML, > 20% blasts on baseline bone marrow assessment
- For patients presenting with relapsed AML, > 5% blasts on baseline bone marrow assessment
Who cannot join
- An initial diagnosis of acute promyelocytic leukemia (as defined by French-American-British criteria (Bennett 1976))
- Secondary AML, defined as AML evolving from antecedent hematological disorder or prior exposure to leukemogenic therapy or agent
- Clinically active CNS leukemia
- Previously received a total cumulative dose of cytarabine > 6g/m2 in the last 6 months
- Previously received > 1 induction regimen (Defined as 1 or 2 cycles of a drug or a drug combination administered as remission induction therapy)
Trial locations and contacts
14 sites in 4 countries.
14 sites in 4 countries
Australia5 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
The Alfred Hospital
Melbourne, Victoria, 3004
Royal Perth Hospital
Perth, Western Australia, 6000
Royal North Shore Hospital
St Leonards, New South Wales, 2065
Westmead Hospital
Westmead, New South Wales, 2145
Taiwan5 sites
Changhua Christian Hospial
Changhua, Changhua Country, 500
China Medical University Hospital
Taichung, 40447
Taipei Veterans General Hospital
Taipei, 112
Tri-Service General Hospital
Taipei, 114
National Taiwan University Hospital
Taipei
United States3 sites
Medical University of South Carolina
Charleston, South Carolina, 29425
UCLA
Los Angeles, California, 90095
Weill Medical College of Cornell University
New York, New York, 10021
About this study
Official title: An Open-label Randomized Controlled Phase II Study of AS1411 Combined With Cytarabine in the Treatment of Patients With Primary Refractory or Relapsed Acute Myeloid Leukemia
This is an open label randomized controlled phase II study of AS1411 combined with Cytarabine in the treatment of patients with primary refractory or relapsed acute myeloid leukemia.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- AS1411, Cytarabine
- Keywords
- AS1411, AML, relapsed, refractory, aptamer, nucleolin
- Medical subject headings
- Leukemia, Myeloid, Acute, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AS1411Drug
AS1411 40mg/kg/day or AS1411 80mg/kg/day
CytarabineDrug
Also called Ara-C
Cytarabine 2g/m2 bid Days 4-7
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | cytarabine 2g/m2 bid Days 4-7 Receives: Drug: Cytarabine |
| AS1411-40 | Experimental | AS1411 40mg/kg/day d1-7 plus cytarabine 2g/m2 bid days 4-7 Receives: Drug: AS1411; Drug: Cytarabine |
| AS1411-80 | Experimental | AS1411 80mg/kg/day d1-7, cytarabine 2g/m2 bid days 4- 7/ bid d4-7 Receives: Drug: AS1411; Drug: Cytarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the response rate (CR + CRi) of AS1411 at 40 and 80mg/kg/day in combination with cytarabine therapy with the response rate (CR + CRi) of cytarabine therapy alone
Measured: Dec 2011
Secondary outcomes (5)
To compare duration of remission, disease free survival and overall survival of AS1411 at 40 or 80mg/kg/day in combination with cytarabine therapy with that of cytarabine alone.
Measured: Dec 2011
To compare the time to hematological recovery of AS1411 at 40 or 80mg/kg/day in combination with cytarabine therapy with that of cytarabine alone.
Measured: Dec 2011
To compare the safety of AS1411 at 40 or 80mg/kg/day in combination with cytarabine therapy with that of cytarabine alone.
Measured: Dec 2011
To evaluate and compare a range of PD markers in patients administered AS1411 in combination with cytarabine therapy with the same PD markers in patients administered cytarabine therapy alone.
Measured: Dec 2011
To further define the PK of AS1411
Measured: Dec 2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2009 (estimated)
- Study startJan 2010
- Primary completionJan 2011
- Study completionJan 2011
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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Antisoma Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Rob Stuart, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01034410
- Sponsor's protocol ID
- AS1411-C-203
- Status last verified
- Feb 2011
- First submitted
- 16 Dec 2009
- Last updated
- 2 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Randomized Controlled Phase II Study of AS1411 Combined With Cytarabine in the Treatment of Patients With Primary Refractory or Relapsed Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT01034410
- Acronym / sponsor ID
- AS1411-C-203
- Conditions
- Acute Myeloid Leukemia
- Keywords
- AS1411, AML, relapsed, refractory, aptamer, nucleolin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Antisoma ResearchIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 17 Dec 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.
This is an open label randomized controlled phase II study of AS1411 combined with Cytarabine in the treatment of patients with primary refractory or relapsed acute myeloid leukemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Drug: Cytarabinecytarabine 2g/m2 bid Days 4-7 |
| AS1411-40 | Experimental | Drug: AS1411, Drug: CytarabineAS1411 40mg/kg/day d1-7 plus cytarabine 2g/m2 bid days 4-7 |
| AS1411-80 | Experimental | Drug: AS1411, Drug: CytarabineAS1411 80mg/kg/day d1-7, cytarabine 2g/m2 bid days 4- 7/ bid d4-7 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of AML as defined by the World Health Organization (WHO) classification (Vardiman 2009)
- Primary refractory AML (defined as a failure to achieve a CR or CRi after therapy with curative intent) or AML in first relapse
- ECOG Performance status 0, 1 or 2
- Age > 18 and < 70 years
- For patients presenting with primary refractory AML, > 20% blasts on baseline bone marrow assessment
Key exclusion criteria (5 listed)
- An initial diagnosis of acute promyelocytic leukemia (as defined by French-American-British criteria (Bennett 1976))
- Secondary AML, defined as AML evolving from antecedent hematological disorder or prior exposure to leukemogenic therapy or agent
- Clinically active CNS leukemia
- Previously received a total cumulative dose of cytarabine > 6g/m2 in the last 6 months
- Previously received > 1 induction regimen (Defined as 1 or 2 cycles of a drug or a drug combination administered as remission induction therapy)
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 |
|---|---|---|
| AS1411AS1411 40mg/kg/day or AS1411 80mg/kg/day | Drug | AS1411-40, AS1411-80 |
| CytarabineAlso: Ara-CCytarabine 2g/m2 bid Days 4-7 | Drug | AS1411-40, AS1411-80, Control |
Primary outcome
To compare the response rate (CR + CRi) of AS1411 at 40 and 80mg/kg/day in combination with cytarabine therapy with the response rate (CR + CRi) of cytarabine therapy alone
Time frame: Dec 2011
5 secondary outcomes
To compare duration of remission, disease free survival and overall survival of AS1411 at 40 or 80mg/kg/day in combination with cytarabine therapy with that of cytarabine alone.
Time frame: Dec 2011
To compare the time to hematological recovery of AS1411 at 40 or 80mg/kg/day in combination with cytarabine therapy with that of cytarabine alone.
Time frame: Dec 2011
To compare the safety of AS1411 at 40 or 80mg/kg/day in combination with cytarabine therapy with that of cytarabine alone.
Time frame: Dec 2011
To evaluate and compare a range of PD markers in patients administered AS1411 in combination with cytarabine therapy with the same PD markers in patients administered cytarabine therapy alone.
Time frame: Dec 2011
To further define the PK of AS1411
Time frame: Dec 2011
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2011.
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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.
Rob Stuart, MD principal investigator
Medical University of South Carolina
14 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AS1411 and Cytarabine in people with Acute Myeloid Leukemia, run by Antisoma Research at 14 sites in 4 countries.
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 5 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: stopped early, as of the sponsor's last update on 2 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Australia, Taiwan, United States, New Zealand. 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?
The study was stopped early. 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?
To compare the response rate (CR + CRi) of AS1411 at 40 and 80mg/kg/day in combination with cytarabine therapy with the response rate (CR + CRi) of cytarabine therapy alone (time frame: Dec 2011). 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 2 Feb 2011.