Leukemia, MyeloidPhase 2NCT00512083
Phase II Study of AS1411 Combined With Cytarabine to Treat Acute Myeloid Leukemia
A Phase 2 study testing AS1411 in people with Leukemia, Myeloid, run by Antisoma Research at 10 sites in 2 countries.
Trial summary
The overall aim of this study is to assess the efficacy and safety of AS1411, over a range of doses, when combined with cytarabine, in the treatment of patients with primary refractory or relapsed acute myeloid leukemia (AML). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Myeloid
- What is being tested?
- AS1411
- Type of treatment
- Injection or infusion
- How many people
- 70 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Jul 2007to Apr 2009
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- primary refractory or relapsed AML
- confirmed diagnosis of AML (de novo or secondary) as defined by WHO classification (Vardiman 2002)
- aged at least 18 years
Who cannot join
- initial diagnosis of acute promyelocytic leukemia as defined by French-American-British criteria (Bennett 1976)
- patient in blast crisis stage of chronic myeloid leukemia
- received high-dose cytarabine (total cumulative dose of >6g/m sq)in last 6 months
- interval of <6 months between first onset of last complete remission and current relapse
- those with primary refractory leukemia who have received more than three previous induction cycles
- relapsed patients who have received more than three previous treatment regimens
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States9 sites
Univeristy of Colorado Health Cancer Center
Aurora, Colorado, 80010
St. Francis Hospital and Health Center
Beech Grove, Indiana, 46107
Medical University of South Carolina
Charleston, South Carolina, 29425
Duke University Medical Center
Durham, North Carolina, 27710
UCLA Medical Center
Los Angeles, California, 90095
University of Louisville, James Graham Brown Cancer Center
Louisville, Kentucky, 40202
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Cancer Therapy and Research Center - Institute for Drug development
San Antonio, Texas, 78229
Washington University
St Louis, Missouri, 63110
About this study
Official title: An Open Label Randomized Controlled Dose Escalating Phase II Study of AS1411 Combined With Cytarabine in the Treatment of Patients With Primary Refractory or Relapsed Acute Myeloid Leukemia
The overall aim of this study is to assess the efficacy and safety of AS1411, over a range of doses, when combined with cytarabine, in the treatment of patients with primary refractory or relapsed acute myeloid leukemia (AML).
- Conditions
- Leukemia, Myeloid
- Being tested
- AS1411
- Keywords
- Leukemia, Myeloid + Acute Disease
- Medical subject headings
- Leukemia, Myeloid, Leukemia, Acute Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AS1411Drug
AS1411 IV administration continuously over 7 days. Dose either 10mg/kg/day or 40 mg/kg/day.
What is being measured
The primary outcome is the main question the study is designed to answer.
The prorportion of patients achieving a completel response (CR) after the first cycle of treatment in each treatment group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2007 (estimated)
- Study startJul 2007
- Primary completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, MyeloidStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Antisoma Research
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00512083
- Sponsor's protocol ID
- AS1411-C-201
- Status last verified
- Sep 2009
- First submitted
- 6 Aug 2007
- Last updated
- 25 Sep 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Randomized Controlled Dose Escalating Phase II Study of AS1411 Combined With Cytarabine in the Treatment of Patients With Primary Refractory or Relapsed Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT00512083
- Acronym / sponsor ID
- AS1411-C-201
- Conditions
- Leukemia, Myeloid
- Keywords
- Leukemia, Myeloid + Acute Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Antisoma ResearchIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Apr 2009 (actual)
- First posted
- 7 Aug 2007 (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 overall aim of this study is to assess the efficacy and safety of AS1411, over a range of doses, when combined with cytarabine, in the treatment of patients with primary refractory or relapsed acute myeloid leukemia (AML).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- primary refractory or relapsed AML
- confirmed diagnosis of AML (de novo or secondary) as defined by WHO classification (Vardiman 2002)
- aged at least 18 years
Key exclusion criteria (6 listed)
- initial diagnosis of acute promyelocytic leukemia as defined by French-American-British criteria (Bennett 1976)
- patient in blast crisis stage of chronic myeloid leukemia
- received high-dose cytarabine (total cumulative dose of >6g/m sq)in last 6 months
- interval of <6 months between first onset of last complete remission and current relapse
- those with primary refractory leukemia who have received more than three previous induction cycles
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 IV administration continuously over 7 days. Dose either 10mg/kg/day or 40 mg/kg/day. | Drug | – |
Primary outcome
The prorportion of patients achieving a completel response (CR) after the first cycle of treatment in each treatment group
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2009.
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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.
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AS1411 in people with Leukemia, Myeloid, run by Antisoma Research at 10 sites in 2 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 3 inclusion and 6 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: finished, as of the sponsor's last update on 25 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The prorportion of patients achieving a completel response (CR) after the first cycle of treatment in each treatment group. 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 25 Sep 2009.