Acute Myeloid LeukemiaPhase 2NCT01843179
Sulindac for Patients With AML
A Phase 2 study testing Cytarabine and Sulindac in people with Acute Myeloid Leukemia, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of an investigational drug to learn whether the drug is effective in treating a specific cancer. "Investigational" means that sulindac is still being studied and that research doctors are trying to find out more about it. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Cytarabine and Sulindac
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Jan 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically confirmed newly diagnosed acute myelogenous leukemia in complete remission following induction chemotherapy
Who cannot join
- Plan for consolidative stem cell transplant in CR1 at the time of enrollment
- Previous history of coronary artery disease or heart failure
- Previous history of major allergic reaction to aspirin or other non-steroidal anti-inflammatory drugs
- Previous history of gastric or duodenal ulceration
- Diagnosis of acute promyelocytic leukemia
- Diagnosis of acute bilineal/biphenotypic leukemia
Show all 16Show fewer
- History of a different malignancy unless disease free for at least 5 years or diagnosed and treated for cervical cancer in situ, basal or squamous cell carcinoma of the skin
- Uncontrolled intercurrent illness that would limit compliance with study requirements
- Disseminated intravascular coagulation
- HIV positive on combination anti-retroviral therapy
- Known active hepatitis B or C
- History of coronary artery disease
- Current or history of congestive heart failure
- History of ventricular arrhythmia
- Patients with mental deficits or psychiatric conditions that preclude them form giving informed consent and following protocol
- Pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02115
About this study
Official title: A Phase II Study of Sulindac, a COX Inhibitor, in Older Patients With Acute Myeloid Leukemia in First Complete Remission
This research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of an investigational drug to learn whether the drug is effective in treating a specific cancer. "Investigational" means that sulindac is still being studied and that research doctors are trying to find out more about it. It also means that the FDA has not yet approved the use of sulindac for your type of cancer.
Participants in this study must have undergone previous chemotherapy and achieved complete remission, which is the absence of disease activity in people with a chronic illness, in this case AML. Unfortunately, a significant number of patients with AML who achieve a complete remission with initial chemotherapy eventually experience a relapse, often within a few months.
Read more
Previous research studies have demonstrated that a type of medication frequently used to treat inflammation, called a COX inhibitor, may suppress and kill leukemia cells. COX inhibitors work by blocking a class of proteins called COX proteins. Other commonly used COX inhibitors are ibuprofen and naproxen.
For this study, the investigators are using a COX inhibitor called sulindac, which has been FDA approved and used to treat pain and inflammation for many years, and has also been studied in suppressing certain tumors of the gastrointestinal system. The main goal of this study is to determine whether sulindac can help participants remain in a state of complete remission following the initial course of chemotherapy for AML, and two cycles of chemotherapy that is standard of care for your cancer, called consolidation chemotherapy. During the course of this study, the investigators will also attempt to learn more about how COX inhibition suppresses the emergence of leukemia, at the molecular and cellular level, by studying the participants on this trial.
Read the detailed description
To determine if you are eligible to participate in this study you will be asked to undergo some screening tests or procedures. Many of these tests and procedures are likely to be part of regular cancer care and may be done even if it turns out you do not take part in the research study. If you have had some of these tests or procedures recently, they may or may not have to be repeated. These procedures include a medical history, performance status, medical record review, routine blood tests, electrocardiogram, echocardiogram and research blood samples. If these tests show that you are eligible to participate in the research study, you will begin the study treatment. If you do not meet the eligibility criteria, you will not be able to participate in this research study.
You will begin the study with up to two cycles of chemotherapy that is an accepted approach treatment of your type of leukemia. This is called consolidation chemotherapy. If you experience severe side effects, you may only be given one cycle. You will begin to take sulindac after you complete consolidation therapy. The consolidation therapy that is commonly used for your type of cancer is a chemotherapy drug called cytarabine. Each cycle of consolidation chemotherapy will be 28 days, or four weeks. You will receive cytarabine via IV infusion on Days 1-5 of each cycle, over a period of 3 hours. You will be admitted to MGH for approximately a week during each cycle of consolidation chemotherapy with cytarabine.
Before starting sulindac, the same tests and procedures done at the screening visit listed above will be repeated. This visit is "Day 0", meaning it takes place prior to study treatment with sulindac. In addition, you will also have a sample of your bone marrow taken for research purposes. This sample is related to the study and will help us understand better the activity of the study drug, sulindac, on leukemia cells and the effect of the body on the sulindac.
You will take sulindac twice a day. Sulindac comes in the form of tablets and can be taken at home by mouth. Your first day of taking sulindac will be called day 1. The following tests and procedures will be one in the outpatient clinic on Day 1 of the study: Blood samples will be taken at 3 points on day 1. These will occur before the first dose of sulindac, 1 hour after the first dose of sulindac, and 4 hours after the first dose of sulindac. Approximately 3 teaspoons of blood will be drawn each time. These samples are related to the study and will help us understand better the activity of the study drug, sulindac, on leukemia cells and the effect of the body on sulindac.
You will come into the clinic for dosing on day 2 (Visit 3) of the study. Approximately 3 teaspoons of blood will be drawn before dosing. 3 teaspoons of blood will also be drawn prior to dosing on days 8, 15 and 28 of study treatment with sulindac. These samples will be stored for as long as research is ongoing with currently no end date. You will continue sulindac twice daily for the duration of the study, which will be 12 months.
You will be monitored for bleeding, since COX inhibitors can also decrease platelet function and affect clotting abilities, and for gastritis or ulcer disease, as COX inhibitors can damage the lining of the stomach. These occur in the minority of participants, but you will be monitored closely on this study for these unexpected effects.
If you develop toxicities on therapy, your dose of sulindac may be reduced or if your symptoms are severe enough, you may be taken off sulindac. If for whatever reason you are unable to participate in the study or adhere to the schedules and study treatments, you will be taken off the study treatment and discontinued from the study. You may choose to stop treatment and come off the study at any time.
We would like to keep track of your medical condition and overall health following the 12 months of study treatment on study with sulindac. This will not involve any communication, but only occasional review of your medical record in regards to medical condition and overall health.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Cytarabine, Sulindac
- Keywords
- Newly diagnosed, Complete Remission
- Medical subject headings
- Leukemia, Myeloid, Acute, Pathologic Complete Response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CytarabineDrug
Up to two cycles. Administered via IV infusion on Days 1-5 of each 28 day cycle
SulindacDrug
Taken orally twice per day at home for 12 months
| Study group | Role | What they receive |
|---|---|---|
| Sulindac Treatment Arm | Experimental | Induction Chemotherapy followed by treatment with sulindac Receives: Drug: Cytarabine; Drug: Sulindac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of sulindac in maintaining complete remission
To define the efficacy of the COX inhibitor sulindac in maintaining complete remission in older patients with AML who achieve remission after induction chemotherapy
Measured: 2 years
Secondary outcomes (3)
Assess and grade toxicity of sulindac treatment
To assess for safety and tolerability of sulindac in the post-induction setting for this patient population through recording and grading of related toxicity
Measured: 2 years
Assessment of survival
To assess for relapse free survival, time to relapse and overall survival
Measured: 2 years
Correlative pharmacodynamic studies including B-catenin protein levels and expression levels of B-catenin downstream genes
To perform correlative pharmacodynamic studies including B-catenin protein levels and expression levels of B-catenin downstream genes
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2013 (estimated)
- Study startJan 2014
- Primary completionJan 2014 (estimated)
- Study completionJan 2014
Why it stopped: Lack of Funding
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.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amir Fathi, Massachusetts General Hospital
- Investigators
- Amir Fathi, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01843179
- Sponsor's protocol ID
- 12-302
- Status last verified
- Feb 2017
- First submitted
- 22 Apr 2013
- Last updated
- 17 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Sulindac, a COX Inhibitor, in Older Patients With Acute Myeloid Leukemia in First Complete Remission
- ClinicalTrials.gov ID
- NCT01843179
- Acronym / sponsor ID
- 12-302
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Newly diagnosed, Complete Remission
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of Funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Jan 2014
- First posted
- 30 Apr 2013 (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 research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of an investigational drug to learn whether the drug is effective in treating a specific cancer. "Investigational" means that sulindac is still being studied and that research doctors are trying to find out more about it. It also means that the FDA has not yet approved the use of sulindac for your type of cancer.
Participants in this study must have undergone previous chemotherapy and achieved complete remission, which is the absence of disease activity in people with a chronic illness, in this case AML. Unfortunately, a significant number of patients with AML who achieve a complete remission with initial chemotherapy eventually experience a relapse, often within a few months.
Previous research studies have demonstrated that a type of medication frequently used to treat inflammation, called a COX inhibitor, may suppress and kill leukemia cells. COX inhibitors work by blocking a class of proteins called COX proteins. Other commonly used COX inhibitors are ibuprofen and naproxen.
For this study, the investigators are using a COX inhibitor called sulindac, which has been FDA approved and used to treat pain and inflammation for many years, and has also been studied in suppressing certain tumors of the gastrointestinal system. The main goal of this study is to determine whether sulindac can help participants remain in a state of complete remission following the initial course of chemotherapy for AML, and two cycles of chemotherapy that is standard of care for your cancer, called consolidation chemotherapy. During the course of this study, the investigators will also attempt to learn more about how COX inhibition suppresses the emergence of leukemia, at the molecular and cellular level, by studying the participants on this trial.
Detailed description
To determine if you are eligible to participate in this study you will be asked to undergo some screening tests or procedures. Many of these tests and procedures are likely to be part of regular cancer care and may be done even if it turns out you do not take part in the research study. If you have had some of these tests or procedures recently, they may or may not have to be repeated. These procedures include a medical history, performance status, medical record review, routine blood tests, electrocardiogram, echocardiogram and research blood samples. If these tests show that you are eligible to participate in the research study, you will begin the study treatment. If you do not meet the eligibility criteria, you will not be able to participate in this research study.
You will begin the study with up to two cycles of chemotherapy that is an accepted approach treatment of your type of leukemia. This is called consolidation chemotherapy. If you experience severe side effects, you may only be given one cycle. You will begin to take sulindac after you complete consolidation therapy. The consolidation therapy that is commonly used for your type of cancer is a chemotherapy drug called cytarabine. Each cycle of consolidation chemotherapy will be 28 days, or four weeks. You will receive cytarabine via IV infusion on Days 1-5 of each cycle, over a period of 3 hours. You will be admitted to MGH for approximately a week during each cycle of consolidation chemotherapy with cytarabine.
Before starting sulindac, the same tests and procedures done at the screening visit listed above will be repeated. This visit is "Day 0", meaning it takes place prior to study treatment with sulindac. In addition, you will also have a sample of your bone marrow taken for research purposes. This sample is related to the study and will help us understand better the activity of the study drug, sulindac, on leukemia cells and the effect of the body on the sulindac.
You will take sulindac twice a day. Sulindac comes in the form of tablets and can be taken at home by mouth. Your first day of taking sulindac will be called day 1. The following tests and procedures will be one in the outpatient clinic on Day 1 of the study: Blood samples will be taken at 3 points on day 1. These will occur before the first dose of sulindac, 1 hour after the first dose of sulindac, and 4 hours after the first dose of sulindac. Approximately 3 teaspoons of blood will be drawn each time. These samples are related to the study and will help us understand better the activity of the study drug, sulindac, on leukemia cells and the effect of the body on sulindac.
You will come into the clinic for dosing on day 2 (Visit 3) of the study. Approximately 3 teaspoons of blood will be drawn before dosing. 3 teaspoons of blood will also be drawn prior to dosing on days 8, 15 and 28 of study treatment with sulindac. These samples will be stored for as long as research is ongoing with currently no end date. You will continue sulindac twice daily for the duration of the study, which will be 12 months.
You will be monitored for bleeding, since COX inhibitors can also decrease platelet function and affect clotting abilities, and for gastritis or ulcer disease, as COX inhibitors can damage the lining of the stomach. These occur in the minority of participants, but you will be monitored closely on this study for these unexpected effects.
If you develop toxicities on therapy, your dose of sulindac may be reduced or if your symptoms are severe enough, you may be taken off sulindac. If for whatever reason you are unable to participate in the study or adhere to the schedules and study treatments, you will be taken off the study treatment and discontinued from the study. You may choose to stop treatment and come off the study at any time.
We would like to keep track of your medical condition and overall health following the 12 months of study treatment on study with sulindac. This will not involve any communication, but only occasional review of your medical record in regards to medical condition and overall health.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sulindac Treatment Arm | Experimental | Drug: Cytarabine, Drug: SulindacInduction Chemotherapy followed by treatment with sulindac |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Pathologically confirmed newly diagnosed acute myelogenous leukemia in complete remission following induction chemotherapy
Key exclusion criteria (16 listed)
- Plan for consolidative stem cell transplant in CR1 at the time of enrollment
- Previous history of coronary artery disease or heart failure
- Previous history of major allergic reaction to aspirin or other non-steroidal anti-inflammatory drugs
- Previous history of gastric or duodenal ulceration
- Diagnosis of acute promyelocytic leukemia
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 |
|---|---|---|
| CytarabineUp to two cycles. Administered via IV infusion on Days 1-5 of each 28 day cycle | Drug | Sulindac Treatment Arm |
| SulindacTaken orally twice per day at home for 12 months | Drug | Sulindac Treatment Arm |
Primary outcome
Efficacy of sulindac in maintaining complete remission
Time frame: 2 years
To define the efficacy of the COX inhibitor sulindac in maintaining complete remission in older patients with AML who achieve remission after induction chemotherapy
3 secondary outcomes
Assess and grade toxicity of sulindac treatment
Time frame: 2 years
Assessment of survival
Time frame: 2 years
Correlative pharmacodynamic studies including B-catenin protein levels and expression levels of B-catenin downstream genes
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2017.
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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.
Amir Fathi, MD principal investigator
Massachusetts General Hospital
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 Cytarabine and Sulindac in people with Acute Myeloid Leukemia, run by Massachusetts General Hospital at 1 site in United States.
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 1 inclusion and 16 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: withdrawn, as of the sponsor's last update on 17 Feb 2017. 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 United States. 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 withdrawn before enrolling participants, so there are no results.
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?
Efficacy of sulindac in maintaining complete remission (time frame: 2 years). 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 17 Feb 2017; AzTrials last refreshed its copy on 30 Oct 2026.