Acute Myelogenous LeukemiaPhase 1NCT01779843
Alisertib for Acute Myeloid Leukemia
A Phase 1 study testing Cytarabine, Idarubicin and Alisertib in people with Acute Myelogenous Leukemia, run by Massachusetts General Hospital at 3 sites in United States.
Trial summary
This research study is a Phase I clinical trial. Phase I trials test the safety of an investigational drug or combination of drugs. Phase I studies also try to define the appropriate dose of the investigational drug to use for further studies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myelogenous Leukemia
- What is being tested?
- Cytarabine, Idarubicin and Alisertib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2013to Nov 2016
- Phase
- Phase 1
- 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
- Pathologically confirmed, newly diagnosed acute myelogenous leukemia
- Agree to use an acceptable method for contraception during the entire study treatment period through 4 months after the last dose of MLN8237
- Able to take oral medication and to maintain a fast as required for 2 hours before and 1 hour after MLN8237 administration
Who cannot join
- Have received systemic antineoplastic therapy, including radiotherapy within 14 days of study treatment, with the exception of hydroxyurea or 6-mercaptopurine for the purposes of cytoreduction
- Pregnant or breastfeeding
- Presence of "favorable" or "better risk" cytogenic prognosis
- Prior allogeneic bone marrow or organ transplantation
- Diagnosis of acute bilineal/biphenotypic leukemia
- History of a different malignancy except if disease-free for at least 5 years and at low risk or recurrence; or cervical cancer in situ, basal cell or squamous cell carcinoma of the skin within the past 5 years
Show all 15Show fewer
- Uncontrolled intercurrent illness
- HIV positive on combination antiretroviral therapy
- Diagnosis of active hepatitis B or C
- Current or history of congestive heart failure NYHA class 3 or 4, or documented diastolic or systolic dysfunction
- Current or history of ventricular or life threatening arrhythmias or diagnosis of long QT syndrome
- Known history of uncontrolled sleep apnea syndrome or other condition that could result in excessive daytime sleepiness
- Requirement for constant administration of proton pump inhibitor, H2 antagonist or pancreatic enzymes
- Systemic infection requiring IV antibiotic therapy within 14 days of first dose of study drug
- Treatment with clinically significant enzyme inducers
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
About this study
Official title: A Phase I Study of the Aurora A Kinase Inhibitor Alisertib in Combination With 7+3 Induction Chemotherapy in Patients With Acute Myeloid Leukemia
This research study is a Phase I clinical trial. Phase I trials test the safety of an investigational drug or combination of drugs. Phase I studies also try to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the combination of drugs is still being studied and that research doctors are trying to find out more about it. As part of this research study, you will take alisertib in combination with idarubicin and cytarabine. Alisertib has not been approved by the FDA for your cancer. However, cytarabine and idarubicin have both been approved by the FDA for treatment of AML. It also means that the FDA has not approved giving alisertib with idarubicin and cytarabine for use in patients, including patients with your type of cancer.
Idarubicin and cytarabine are chemotherapy agents that are commonly used to treat individuals diagnosed with AML. Alisertib has been used in laboratory studies and those studies suggest that alisertib may slow down the spread of your cancer. It does this by blocking certain substances needed by the cancer cells to spread. In this study, researchers would like to combine alisertib with standard chemotherapy (cytarabine and idarubicin) in order to see if it can be given safely with chemotherapy in individuals with AML.
The primary purpose of this research study is to determine the highest dose that alisertib can be given with idarubicin and cytarabine without severe or unmanageable side effects. The dose identified in this study will be used in future research studies.
Read the detailed description
If you agree to take part in this study you will be asked to undergo some screening tests or procedures to find out if you can be in the research study. Many of these tests and procedures are likely to be part of regular cancer care and may be done even if it turns out that 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 need to be repeated. These tests and procedures include: a medical history, physical exam, performance status, urine test, Electrocardiogram, Echocardiogram, blood tests and a bone marrow aspirate/biopsy. 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 treatment with idarubicin, and cytarabine followed by alisertib several days later (on day 8). Not everyone who participates in this research study will receive the same dose of the study drug. The dose you get will depend on the number of participants who have been enrolled in the study before you and how well they have tolerated their doses. The following assessments will be completed while on trial: physical exam, performance status, urine test, blood tests, bone marrow aspirate/biopsy.
The first part of the study procedure is called "induction". During induction you will be admitted to the hospital on an in-patient basis. You will receive cytarabine and idarubicin by IV (intravenously or through a vein). Cytarabine will be given by continuous IV infusion for seven days, beginning on Day 1. Idarubicin will be given once each day as an IV injection for a total of three days, beginning on the same day as cytarabine. If idarubicin is not available, you may receive a very similar chemotherapy in its place called daunorubicin. Alisertib will be given orally (by mouth) twice a day for one week. It will start on the second week of treatment.
A bone marrow biopsy will be performed at approximately 14 days after the start of chemotherapy. If the results of this biopsy detect residual leukemia in the bone marrow, your physicians may give you another round of induction therapy. However, this time, cytarabine will be given by continuous IV infusion for only five days, and idarubicin will be given once each day as an IV injection for a total of 2 days, again beginning on the same day as cytarabine.
If at the end of the first cycle of induction (whether you've received one round or two rounds of induction) the number of leukemia cells have not decreased as much as expected or desired, you will be removed from the study and given alternative options.
The second part of study procedure is called "consolidation". If you have achieved a remission after your induction phase, you are not a candidate for a bone marrow transplant, and you tolerated study drug well during induction, you may receive consolidation treatment. Soem participants may not receive consolidation therapy on this trial, based on the advice of their treating physician.
For consolidation, you will receive a higher dose of cytarabine than you did during induction. You will be hospitalized and cytarabine will be given daily as an IV infusion for five days. Alisertib will also be given during the consolidation phase of therapy. It will start at the end of the cytarabine administration and be given for a total of seven days. You may receive up to four cycles of consolidation treatment, depending on your disease and the discretion of your treating physician.
The third part of study procedures is called "maintenance". After the induction course of therapy, your physician may begin consolidation therapy. If this is the case, you will start maintenance therapy after finishing consolidation therapy. If consolidation is not done, the maintenance phase will start after induction.
During maintenance, you will take alisertib twice daily for a period of seven days, followed by a two week break without treatment. This one week of therapy, followed by two weeks off therapy, will be a 21-day cycle. It will be repeated until 12 months have passed from the start of the maintenance therapy phase. During this phase, participants will not receive other chemotherapies and will not be hospitalized for treatment. They will take alisertib at home and will be followed in clinic for monitoring. During the maintenance phase, we will continue to collect approximately 2 to 3 teaspoons of blood for research purposes intermittently on your visits to clinic.
After the final dose of the study drug we would like to keep track of your medical condition and overall health following the 12 months of alisertib. We may ask you questions about your general health, current medications, and disease status. We will also check on any new anticancer therapy you may have started.
- Conditions
- Acute Myelogenous Leukemia
- Being tested
- Cytarabine, Idarubicin, Alisertib
- Keywords
- Newly diagnosed
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CytarabineDrug
IdarubicinDrug
AlisertibDrug
Also called MLN8237
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Induction: 100 mg/m2/day Cytarabine intravenous, days 1-7 of induction cycle. 12 mg/m2/day Idarubicin intravenous, days 1-3. Alisertib orally, twice a day for one week starting on day 8, dose escalation-starting dose 10 mg PO BID.
Consolidation: Cytarabine 3 g/m2 by IV infusion over 3 hours given every 12 hours on Days 1, 3 and 5 (subjects younger than age 60) or Cytarabine 2 g/m2 per day by IV infusion over 3 hours on days 1-5 (subjects at or older than age 60) Receives: Drug: Cytarabine; Drug: Idarubicin; Drug: Alisertib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose of Alisertib in combination with 7+3 induction chemotherapy
The maximum tolerated dose (MTD) of the aurora kinase A inhibitor alisertib (MLN8237) in combination with 7+3 induction chemotherapy in patients with acute myeloid leukemia
Measured: 2 years
Evaluate safety and tolerability of alisertib, including number of adverse events and severity.
The number and severity of adverse events associated with this treatment.
Measured: 2 years
Secondary outcomes (4)
Severity and number of all trial-related toxicities
To detect and categorize, according to severity, the cumulative incidences of drug related toxicities
Measured: 2 years
Rates of response
To determine the response rate, including rates of complete and partial remission
Measured: 2 years
One-year relapse-free and overall survival
To measure the one-year relapse-free and overall survival after treatment
Measured: 2 years
Measurement of tumor mitotic index, Ki67 and cPARP statining, Pharmacodynamic parameters for aurora kinase A inhibition, during treatment
To assess pharmacodynamic effects of aurora kinase A inhibition, including tumor mitotic index, Ki67 and cPARP staining
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 Jan 2013 (estimated)
- Study startApr 2013
- Primary completionNov 2015
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myelogenous 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 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
- NCT01779843
- Sponsor's protocol ID
- 12-531
- Status last verified
- Feb 2017
- First submitted
- 25 Jan 2013
- Last updated
- 17 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fathi AT, Wander SA, Blonquist TM, Brunner AM, Amrein PC, Supko J, Hermance NM, Manning AL, Sadrzadeh H, Ballen KK, Attar EC, Graubert TA, Hobbs G, Joseph C, Perry AM, Burke M, Silver R, Foster J, Bergeron M, Ramos AY, Som TT, Fishman KM, McGregor KL, Connolly C, Neuberg DS, Chen YB. Phase I study of the aurora A kinase inhibitor alisertib with induction chemotherapy in patients with acute myeloid leukemia. Haematologica. 2017 Apr;102(4):719-727. doi: 10.3324/haematol.2016.158394. Epub 2016 Dec 29.
PubMed 28034990
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 I Study of the Aurora A Kinase Inhibitor Alisertib in Combination With 7+3 Induction Chemotherapy in Patients With Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT01779843
- Acronym / sponsor ID
- 12-531
- Conditions
- Acute Myelogenous Leukemia
- Keywords
- Newly diagnosed
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 30 Jan 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 I clinical trial. Phase I trials test the safety of an investigational drug or combination of drugs. Phase I studies also try to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the combination of drugs is still being studied and that research doctors are trying to find out more about it. As part of this research study, you will take alisertib in combination with idarubicin and cytarabine. Alisertib has not been approved by the FDA for your cancer. However, cytarabine and idarubicin have both been approved by the FDA for treatment of AML. It also means that the FDA has not approved giving alisertib with idarubicin and cytarabine for use in patients, including patients with your type of cancer.
Idarubicin and cytarabine are chemotherapy agents that are commonly used to treat individuals diagnosed with AML. Alisertib has been used in laboratory studies and those studies suggest that alisertib may slow down the spread of your cancer. It does this by blocking certain substances needed by the cancer cells to spread. In this study, researchers would like to combine alisertib with standard chemotherapy (cytarabine and idarubicin) in order to see if it can be given safely with chemotherapy in individuals with AML.
The primary purpose of this research study is to determine the highest dose that alisertib can be given with idarubicin and cytarabine without severe or unmanageable side effects. The dose identified in this study will be used in future research studies.
Detailed description
If you agree to take part in this study you will be asked to undergo some screening tests or procedures to find out if you can be in the research study. Many of these tests and procedures are likely to be part of regular cancer care and may be done even if it turns out that 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 need to be repeated. These tests and procedures include: a medical history, physical exam, performance status, urine test, Electrocardiogram, Echocardiogram, blood tests and a bone marrow aspirate/biopsy. 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 treatment with idarubicin, and cytarabine followed by alisertib several days later (on day 8). Not everyone who participates in this research study will receive the same dose of the study drug. The dose you get will depend on the number of participants who have been enrolled in the study before you and how well they have tolerated their doses. The following assessments will be completed while on trial: physical exam, performance status, urine test, blood tests, bone marrow aspirate/biopsy.
The first part of the study procedure is called "induction". During induction you will be admitted to the hospital on an in-patient basis. You will receive cytarabine and idarubicin by IV (intravenously or through a vein). Cytarabine will be given by continuous IV infusion for seven days, beginning on Day 1. Idarubicin will be given once each day as an IV injection for a total of three days, beginning on the same day as cytarabine. If idarubicin is not available, you may receive a very similar chemotherapy in its place called daunorubicin. Alisertib will be given orally (by mouth) twice a day for one week. It will start on the second week of treatment.
A bone marrow biopsy will be performed at approximately 14 days after the start of chemotherapy. If the results of this biopsy detect residual leukemia in the bone marrow, your physicians may give you another round of induction therapy. However, this time, cytarabine will be given by continuous IV infusion for only five days, and idarubicin will be given once each day as an IV injection for a total of 2 days, again beginning on the same day as cytarabine.
If at the end of the first cycle of induction (whether you've received one round or two rounds of induction) the number of leukemia cells have not decreased as much as expected or desired, you will be removed from the study and given alternative options.
The second part of study procedure is called "consolidation". If you have achieved a remission after your induction phase, you are not a candidate for a bone marrow transplant, and you tolerated study drug well during induction, you may receive consolidation treatment. Soem participants may not receive consolidation therapy on this trial, based on the advice of their treating physician.
For consolidation, you will receive a higher dose of cytarabine than you did during induction. You will be hospitalized and cytarabine will be given daily as an IV infusion for five days. Alisertib will also be given during the consolidation phase of therapy. It will start at the end of the cytarabine administration and be given for a total of seven days. You may receive up to four cycles of consolidation treatment, depending on your disease and the discretion of your treating physician.
The third part of study procedures is called "maintenance". After the induction course of therapy, your physician may begin consolidation therapy. If this is the case, you will start maintenance therapy after finishing consolidation therapy. If consolidation is not done, the maintenance phase will start after induction.
During maintenance, you will take alisertib twice daily for a period of seven days, followed by a two week break without treatment. This one week of therapy, followed by two weeks off therapy, will be a 21-day cycle. It will be repeated until 12 months have passed from the start of the maintenance therapy phase. During this phase, participants will not receive other chemotherapies and will not be hospitalized for treatment. They will take alisertib at home and will be followed in clinic for monitoring. During the maintenance phase, we will continue to collect approximately 2 to 3 teaspoons of blood for research purposes intermittently on your visits to clinic.
After the final dose of the study drug we would like to keep track of your medical condition and overall health following the 12 months of alisertib. We may ask you questions about your general health, current medications, and disease status. We will also check on any new anticancer therapy you may have started.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Cytarabine, Drug: Idarubicin, Drug: AlisertibInduction: 100 mg/m2/day Cytarabine intravenous, days 1-7 of induction cycle. 12 mg/m2/day Idarubicin intravenous, days 1-3. Alisertib orally, twice a day for one week starting on day 8, dose escalation-starting dose 10 mg PO BID. Consolidation: Cytarabine 3 g/m2 by IV infusion over 3 hours given every 12 hours on Days 1, 3 and 5 (subjects younger than age 60) or Cytarabine 2 g/m2 per day by IV infusion over 3 hours on days 1-5 (subjects at or older than age 60) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Pathologically confirmed, newly diagnosed acute myelogenous leukemia
- Agree to use an acceptable method for contraception during the entire study treatment period through 4 months after the last dose of MLN8237
- Able to take oral medication and to maintain a fast as required for 2 hours before and 1 hour after MLN8237 administration
Key exclusion criteria (15 listed)
- Have received systemic antineoplastic therapy, including radiotherapy within 14 days of study treatment, with the exception of hydroxyurea or 6-mercaptopurine for the purposes of cytoreduction
- Pregnant or breastfeeding
- Presence of "favorable" or "better risk" cytogenic prognosis
- Prior allogeneic bone marrow or organ transplantation
- Diagnosis of acute bilineal/biphenotypic 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 |
|---|---|---|
| Cytarabine | Drug | Treatment |
| Idarubicin | Drug | Treatment |
| AlisertibAlso: MLN8237 | Drug | Treatment |
Primary outcome
Maximum Tolerated Dose of Alisertib in combination with 7+3 induction chemotherapy
Time frame: 2 years
The maximum tolerated dose (MTD) of the aurora kinase A inhibitor alisertib (MLN8237) in combination with 7+3 induction chemotherapy in patients with acute myeloid leukemia
Evaluate safety and tolerability of alisertib, including number of adverse events and severity.
Time frame: 2 years
The number and severity of adverse events associated with this treatment.
4 secondary outcomes
Severity and number of all trial-related toxicities
Time frame: 2 years
Rates of response
Time frame: 2 years
One-year relapse-free and overall survival
Time frame: 2 years
Measurement of tumor mitotic index, Ki67 and cPARP statining, Pharmacodynamic parameters for aurora kinase A inhibition, during treatment
Time frame: 2 years
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 17 Feb 2017.
- Derived from this study: PubMed 28034990Fathi AT, Wander SA, Blonquist TM, Brunner AM, Amrein PC, Supko J, Hermance NM, Manning AL, Sadrzadeh H, Ballen KK, Attar EC, Graubert TA, Hobbs G, Joseph C, Perry AM, Burke M, Silver R, Foster J, Bergeron M, Ramos AY, Som TT, Fishman KM, McGregor KL, Connolly C, Neuberg DS, Chen YB. Phase I study of the aurora A kinase inhibitor alisertib with induction chemotherapy in patients with acute myeloid leukemia. Haematologica. 2017 Apr;102(4):719-727. doi: 10.3324/haematol.2016.158394. Epub 2016 Dec 29.
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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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cytarabine, Idarubicin and Alisertib in people with Acute Myelogenous Leukemia, run by Massachusetts General Hospital at 3 sites 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 3 inclusion and 15 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 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 3 sites 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Maximum Tolerated Dose of Alisertib in combination with 7+3 induction chemotherapy (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01779843, which also lists 1 linked publication.
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.