LeukemiaPhase 2NCT02302846
Study of MLN9708 as Maintenance Therapy for Patients With Acute Myeloid Leukemia (AML) and High Risk Myelodysplastic Syndrome (MDS) in Remission
A Phase 2 study testing Ixazomib in people with Leukemia, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn if ixazomib can prevent AML or MDS from coming back in patients who are in remission. The safety of this drug will also be studied. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia
- What is being tested?
- Ixazomib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2015to 30 May 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Male or female patients 18 years of age or older.
- Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
- Female patients who: Are postmenopausal for at least 1 year, OR Are surgically sterile, OR If they are of childbearing potential, agree to practice 2 effective methods of contraception, from the time of signing the informed consent through 90 days after the last dose of study drug, OR Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception.) Male patients, even if surgically sterilized, must agree to one of the following: Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject.
- Patients must have a history of de novo or therapy-related AML (defined by World Health Organization (WHO) classification of >/= 20% bone marrow blasts) or high-risk MDS (defined by International Prostate Symptom Score (IPSS) or IPSS-R)
- 5. Patients must be in a documented complete response/incomplete blood count recovery (CR/CRi) from either their front-line or first salvage therapy as evidenced by </= 5% bone marrow blasts and absence of extramedullary disease. (For patients with prior MDS who then transformed to AML, therapy received for MDS is not considered prior therapy for AML)
- Patients should have received at least 2 cycles of induction therapy or 1 induction and 1 consolidation cycle, OR patient should be considered to have completed all planned chemotherapy, OR patient is considered to be unable, unfit or unwilling to receive additional chemotherapy.
- Eastern Cooperative Oncology Group (ECOG) performance 0, 1, or 2.
- Patients must meet the following clinical laboratory criteria: - Absolute neutrophil count (ANC) >/= 500/mm3 and platelet count >/= 50,000/mm3. Platelet transfusions to help patients meet eligibility criteria are not allowed within 3 days before study enrollment - Total bilirubin </= 1.5 x the upper limit of the normal range (ULN). - Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST)</= 3 x ULN. - Calculated creatinine clearance >/= 30 mL/min
Who cannot join
- Female patients who are lactating or have a positive serum pregnancy test during the screening period.
- Failure to have fully recovered (ie, </= Grade 1 toxicity) from the reversible effects of prior chemotherapy.
- Major surgery within 14 days before enrollment.
- Radiotherapy within 14 days before enrollment. If the involved field is small, 7 days will be considered a sufficient interval between treatment and administration of the MLN9708.
- Known central nervous system involvement
- Infection requiring systemic antibiotic therapy or other serious infection within 14 days before study enrollment.
Show all 16Show fewer
- Evidence of current uncontrolled cardiovascular conditions, including sustained hypertension (SBP >150mmHg on two or more readings one week apart without normalization in between), clinically significant uncontrolled cardiac arrhythmias, symptomatic Class III-IV New York Heart Association (NYHA) congestive heart failure, unstable angina, or myocardial infarction within the past 6 months.
- Systemic treatment, within 7 days, or the half life of the treatment, whichever is longer before the first dose of MLN9708, with strong inhibitors of CYP1A2 (fluvoxamine, enoxacin, ciprofloxacin), strong inhibitors of cytochrome P CYP3A (clarithromycin, telithromycin, itraconazole, voriconazole, ketoconazole, nefazodone, posaconazole) or strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of Ginkgo biloba or St. John's wort.
- Ongoing or active systemic infection, history of hepatitis B or C virus infection, or known human immunodeficiency virus (HIV) positive.
- Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
- Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.
- Known GI disease or GI procedure that is expected to interfere with the oral absorption or tolerance of MLN9708 including difficulty swallowing. As determined by the investigator.
- Diagnosed or treated for another malignancy within 2 years before study enrollment or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection
- Patient has >/= Grade 3 peripheral neuropathy, or Grade 2 with pain on clinical examination during the screening period.
- Administration of other investigational agents for the treatment of AML/MDS within 21days (or 5 times the terminal half life of the investigational treatment whichever is longer) of the start of this trial and throughout the duration of this trial.
- At the time of registration, stem cell transplantation is not planned within the next 3 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Phase II Study Of Ixazomib As Maintenance Therapy For Patients With Acute Myeloid Leukemia (AML) And High Risk Myelodysplastic Syndrome (MDS) In Remission
The goal of this clinical research study is to learn if ixazomib can prevent AML or MDS from coming back in patients who are in remission. The safety of this drug will also be studied.
Read the detailed description
Study Drug Administration:
Each study cycle is 28 days.
If you are found to be eligible to take part in this study, you will take ixazomib capsules on Days 1, 8 and 15 of each cycle. Ixazomib capsules should be swallowed whole, with water, on an empty stomach (take the dose at least 1 hour before or 2 hours after a meal).
If you miss a dose, take it as soon as you remember, as long as the next scheduled dose is more than 3 days away. If you vomit after taking a dose, do not make up the dose but continue with the next scheduled dose as planned.
You may receive the study drug for up to 12 cycles. If the doctor thinks it is in your best interest, you may be able to continue taking the study drug beyond Cycle 12.
Study Visits:
On Day 1 of each cycle (+/- 1 day):
- You will have a physical exam.
- Blood (about 2-3 teaspoons) will be drawn for routine tests.
On Days 8 and 15 of Cycle 1, blood (about 2-3 teaspoons) will be drawn for routine tests.
Every third cycle, you will have a bone marrow aspiration and/or biopsy to check the status of the disease.
Length of Study:
You may continue taking the study drug for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.
Your participation on the study will be over after the end-of-study visit.
End-of-Study Visit:
After your last dose of study drug, you will return to the clinic for an end-of-study visit.
- Blood (about 2-3 tablespoons) will be drawn for routine tests.
- You will have a bone marrow aspirate and/or biopsy to check the status of the disease.
This is an investigational study. Ixazomib is not FDA-approved or commercially available. It is currently being used for research purposes only. The study doctor can explain how the study drug is designed to work.
Up to 40 participants will be enrolled in this study. All will take part at MD Anderson.
- Conditions
- Leukemia
- Being tested
- Ixazomib
- Keywords
- Leukemia, Acute myeloid leukemia, AML, High-risk myelodysplastic syndrome, MDS, Ixazomib, MLN9708
- Medical subject headings
- Leukemia, Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IxazomibDrug
Also called MLN9708
4 mg by mouth on Days 1, 8 and 15 of each 28-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Ixazomib | Experimental | Participants receive 4 mg oral dose of Ixazomib on Days 1, 8 and 15 of each 28-day cycle. Receives: Drug: Ixazomib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse-Free Survival (RFS)
RFS defined as interval from date of enrollment to date of first objective documentation of disease relapse or death from any cause. Survival or times to failure and time to progression functions estimated using Kaplan-Meier method.
Measured: 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2014 (estimated)
- Study start20 Mar 2015
- Primary completion30 May 2017
- Study completion30 May 2017
Why it stopped: Slow Accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Millennium: The Takeda Oncology Company
- Responsible party
- Sponsor
- Investigators
- Courtney DiNardo, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02302846
- Sponsor's protocol ID
- 2014-0379
- Other IDs
- NCI-2014-02604
- Status last verified
- Oct 2018
- First submitted
- 18 Nov 2014
- Last updated
- 3 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study Of Ixazomib As Maintenance Therapy For Patients With Acute Myeloid Leukemia (AML) And High Risk Myelodysplastic Syndrome (MDS) In Remission
- ClinicalTrials.gov ID
- NCT02302846
- Acronym / sponsor ID
- 2014-0379
- Conditions
- Leukemia
- Keywords
- Leukemia, Acute myeloid leukemia, AML, High-risk myelodysplastic syndrome, MDS, Ixazomib, MLN9708
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow Accrual
- Enrolment
- 5 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Millennium: The Takeda Oncology Company
- Study start
- 20 Mar 2015 (actual)
- Primary completion
- 30 May 2017 (actual)
- Study completion
- 30 May 2017 (actual)
- First posted
- 27 Nov 2014 (estimated)
- Results
- Posted 3 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to learn if ixazomib can prevent AML or MDS from coming back in patients who are in remission. The safety of this drug will also be studied.
Detailed description
Study Drug Administration:
Each study cycle is 28 days.
If you are found to be eligible to take part in this study, you will take ixazomib capsules on Days 1, 8 and 15 of each cycle. Ixazomib capsules should be swallowed whole, with water, on an empty stomach (take the dose at least 1 hour before or 2 hours after a meal).
If you miss a dose, take it as soon as you remember, as long as the next scheduled dose is more than 3 days away. If you vomit after taking a dose, do not make up the dose but continue with the next scheduled dose as planned.
You may receive the study drug for up to 12 cycles. If the doctor thinks it is in your best interest, you may be able to continue taking the study drug beyond Cycle 12.
Study Visits:
On Day 1 of each cycle (+/- 1 day):
- You will have a physical exam.
- Blood (about 2-3 teaspoons) will be drawn for routine tests.
On Days 8 and 15 of Cycle 1, blood (about 2-3 teaspoons) will be drawn for routine tests.
Every third cycle, you will have a bone marrow aspiration and/or biopsy to check the status of the disease.
Length of Study:
You may continue taking the study drug for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.
Your participation on the study will be over after the end-of-study visit.
End-of-Study Visit:
After your last dose of study drug, you will return to the clinic for an end-of-study visit.
- Blood (about 2-3 tablespoons) will be drawn for routine tests.
- You will have a bone marrow aspirate and/or biopsy to check the status of the disease.
This is an investigational study. Ixazomib is not FDA-approved or commercially available. It is currently being used for research purposes only. The study doctor can explain how the study drug is designed to work.
Up to 40 participants will be enrolled in this study. All will take part at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ixazomib | Experimental | Drug: IxazomibParticipants receive 4 mg oral dose of Ixazomib on Days 1, 8 and 15 of each 28-day cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female patients 18 years of age or older.
- Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
- Female patients who: Are postmenopausal for at least 1 year, OR Are surgically sterile, OR If they are of childbearing potential, agree to practice 2 effective methods of contraception, from the time of signing the informed consent through 90 days after the last dose of study drug, OR Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception.) Male patients, even if surgically sterilized, must agree to one of the following: Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject.
- Patients must have a history of de novo or therapy-related AML (defined by World Health Organization (WHO) classification of >/= 20% bone marrow blasts) or high-risk MDS (defined by International Prostate Symptom Score (IPSS) or IPSS-R)
- 5. Patients must be in a documented complete response/incomplete blood count recovery (CR/CRi) from either their front-line or first salvage therapy as evidenced by </= 5% bone marrow blasts and absence of extramedullary disease. (For patients with prior MDS who then transformed to AML, therapy received for MDS is not considered prior therapy for AML)
Key exclusion criteria (16 listed)
- Female patients who are lactating or have a positive serum pregnancy test during the screening period.
- Failure to have fully recovered (ie, </= Grade 1 toxicity) from the reversible effects of prior chemotherapy.
- Major surgery within 14 days before enrollment.
- Radiotherapy within 14 days before enrollment. If the involved field is small, 7 days will be considered a sufficient interval between treatment and administration of the MLN9708.
- Known central nervous system involvement
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 |
|---|---|---|
| IxazomibAlso: MLN97084 mg by mouth on Days 1, 8 and 15 of each 28-day cycle. | Drug | Ixazomib |
Primary outcome
Relapse-Free Survival (RFS)
Time frame: 84 days
RFS defined as interval from date of enrollment to date of first objective documentation of disease relapse or death from any cause. Survival or times to failure and time to progression functions estimated using Kaplan-Meier method.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Courtney DiNardo, MD principal investigator
M.D. Anderson Cancer Center
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 Ixazomib in people with Leukemia, run by M.D. Anderson Cancer Center 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 8 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: stopped early, as of the sponsor's last update on 3 Oct 2018. 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?
Yes. Results are posted in the registry (first posted 3 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Relapse-Free Survival (RFS) (time frame: 84 days). 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 3 Oct 2018.