LeukemiaPhase 2NCT01272245
Omacetaxine and Low Dose Cytarabine in Older Patients With Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome (MDS)
A Phase 2 study testing Omacetaxine and Cytarabine 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 omacetaxine given with cytarabine can help to control the disease in patients with AML or high-risk MDS. The safety of the study drugs will also be studied. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Leukemia
- What is being tested?
- Omacetaxine and Cytarabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Jan 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previously untreated AML (>/= 20% blasts). Patients with high-risk (intermediate-2 or high by International Prostate Symptom Score (IPSS) or ≥10% blasts) MDS will also be eligible. Prior therapy with hydroxyurea, biological or targeted therapy (e.g. flt3 inhibitors, other kinase inhibitors, azacitidine), or hematopoietic growth factors is allowed. A single or a two day dose of cytarabine (up to 3 g/m2) for emergency use is also allowed as prior therapy.
- Age >/= 60 years.
- Eastern Cooperative Oncology Group (ECOG) performance status </= 2.
- Adequate hepatic (serum total bilirubin </= 1.5 x ULN, serum glutamate pyruvate transaminase (SGPT) and/or serum glutamate oxaloacetate transaminase (SGOT) </= 2.5 x ULN) and renal function (creatinine </= 2.0 mg/dL).
- Patients must be willing and able to review, understand, and provide written consent before starting therapy.
Who cannot join
- New York Heart Association (NYHA) class III or IV heart disease, active ischemia or any other uncontrolled cardiac condition such as angina pectoris, clinically significant cardiac arrhythmia and requiring therapy, uncontrolled hypertension (blood pressure >/= 160 systolic and >/= 110 diastolic not responsive to antihypertensive medication), diabetes mellitus, or congestive heart failure.
- Myocardial infarction in the previous 12 weeks (from the start of treatment).
- Active and uncontrolled disease/infection as judged by the treating physician.
- Pregnancy.
- Acute promyelocytic leukemia (APL).
- Women of childbearing potential and men who do not practice contraception. Non-childbearing is defined as >/= 1 year postmenopausal or surgically sterilized.
- Women of childbearing potential and men must agree to use contraception prior to study entry and for the duration of study participation.
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: A Phase II Study of Omacetaxine (OM) and Low Dose Cytarabine (LDAC) in Older Patients With Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome (MDS)
The goal of this clinical research study is to learn if omacetaxine given with cytarabine can help to control the disease in patients with AML or high-risk MDS. The safety of the study drugs will also be studied.
Read the detailed description
Study Drugs:
Omacetaxine is designed to block certain proteins, which may cause cancer cells to die.
Cytarabine is designed to insert itself into DNA (the genetic material of cells) of cancer cells and stop the DNA from repairing itself.
Study Drug Administration:
If you are found to be eligible to take part in this study, you will receive omacetaxine and cytarabine as an injection under the skin. You will receive instructions on how to give these injections to yourself. You will be given a Research Medication Diary to record the drugs you take each day. You must bring the Research Medication Diary and any unused drugs with you to each study visit. You will also be told how to properly store the drugs.
On Days 1-3 of each cycle, you will give yourself an injection of omacetaxine every 12 hours (+/- 3 hours).
On Days 1-7 of each cycle, you will give yourself an injection of cytarabine every 12 hours (+/- 3 hours).
Each cycle will be 4-7 weeks, depending on how well the disease responds to the study drugs.
Depending on how the disease responds to the study drugs, the number of days you receive your injections may stay the same, increase, or decrease. Your doctor will discuss this with you.
Study Visits:
On Day 1 of each cycle, you will have a physical exam.
Women who are able to become pregnant must have a negative blood (about 1/2 teaspoon) or urine pregnancy test within 3 days before receiving the first dose of study drug.
Blood (about 1 tablespoon) will be drawn every week for routine tests. Once you have a response to treatment, blood will then be drawn every 2-4 weeks while you are receiving treatment. If your doctor thinks it is needed, you may have more blood samples drawn during Cycles 1 and 2.
On Day 21 of Cycle 1 (+/- 7 days), then every 4 weeks after that, you will have a bone marrow aspiration and/or biopsy to check the status of the disease. If the doctor thinks it is needed, these may be done more or less often, depending on your response to treatment.
Length of Study:
You may receive up to 24 cycles of treatment. You will be taken off study early if the disease gets worse or intolerable side effects occur.
Follow-up:
Once you stop taking the study drugs, you will have follow-up for 5 years.
Every 4-8 weeks, blood (about 1 tablespoon) will be drawn for routine tests. If you cannot return to the clinic, you may have blood drawn at a clinic close to your home.
Every 3-6 months, you will be contacted during a clinic visit and asked how you are doing. If you cannot make it to the clinic for this visit, you will be called. The phone call should last about 5 minutes.
This is an investigational study. Omacetaxine is FDA approved to treat patients with certain types of leukemia. Its use in this study is investigational. Cytarabine is FDA approved and commercially available for the treatment of AML. The use of these drugs in combination is investigational.
Up to 60 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Leukemia
- Being tested
- Omacetaxine, Cytarabine
- Keywords
- Acute Myelogenous Leukemia, AML, High-Risk Myelodysplastic Syndrome, MDS, Omacetaxine, Cytarabine, ARA-C, Cytosar, DepoCyt, Cytosine Arabinosine Hydrochloride
- 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.
OmacetaxineDrug
1.25 mg/m2 subcutaneously (SQ) every 12 hours (+/- 3 hours) for 3 days (Days 1-3). Each cycle will be 4-7 weeks.
CytarabineDrug
Also called ARA-C, Cytosar, Depo-Cyt, Cytosine Arabinosine Hydrochloride
20 mg subcutaneously every 12 hours (+/- 3 hours) for 7 days (Days 1-7). Each cycle will be 4-7 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Omacetaxine and Cytarabine | Experimental | Omacetaxine 1.25 mg/m2 SQ every 12 hours x 3 days + Cytarabine 20 mg SQ x 7 days of 4-7 week cycle. Receives: Drug: Omacetaxine; Drug: Cytarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Complete Remission (CR)
Complete response (CR) defined as: Peripheral blood counts, no circulating blasts, neutrophil count ≥ 1.0 ×109/L, platelet count ≥ 100 ×109/L, bone marrow aspirate and biopsy, ≤5% blasts, no detectable auer rods, no extramedulary leukemia
Measured: Up to 4 months
Secondary outcomes (4)
Evaluation of CR Duration
The date of Complete Response to the date of loss of response or last follow-up.
Measured: Up to 5 years after completion of active treatment and while on study. Participants may receive up to 24 courses of study medication.
Disease-free Survival
Time from date of treatment start until the date of first objective documentation of disease-relapse.
Measured: Up to 5 years after completion of active treatment and while on study. Participants may receive up to 24 courses of study medication.
Overall Survival
Time from date of treatment start until date of death due to any cause
Measured: Up to 5 years after completion of active treatment and while on study. Participants may receive up to 24 courses of study medication.
Induction Mortality
Death within 8 weeks from the start of treatment.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2011 (estimated)
- Study startJul 2011
- Primary completionJan 2017
- Study completionJan 2017
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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Cephalon
- Responsible party
- Sponsor
- Investigators
- Hagop Kantarjian, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01272245
- Sponsor's protocol ID
- 2010-0736
- Other IDs
- NCI-2013-02220
- Status last verified
- Apr 2018
- First submitted
- 6 Jan 2011
- Last updated
- 30 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Omacetaxine (OM) and Low Dose Cytarabine (LDAC) in Older Patients With Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome (MDS)
- ClinicalTrials.gov ID
- NCT01272245
- Acronym / sponsor ID
- 2010-0736
- Conditions
- Leukemia
- Keywords
- Acute Myelogenous Leukemia, AML, High-Risk Myelodysplastic Syndrome, MDS, Omacetaxine, Cytarabine, ARA-C, Cytosar
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Cephalon
- Study start
- Jul 2011
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 7 Jan 2011 (estimated)
- Results
- Posted 30 May 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 omacetaxine given with cytarabine can help to control the disease in patients with AML or high-risk MDS. The safety of the study drugs will also be studied.
Detailed description
Study Drugs:
Omacetaxine is designed to block certain proteins, which may cause cancer cells to die.
Cytarabine is designed to insert itself into DNA (the genetic material of cells) of cancer cells and stop the DNA from repairing itself.
Study Drug Administration:
If you are found to be eligible to take part in this study, you will receive omacetaxine and cytarabine as an injection under the skin. You will receive instructions on how to give these injections to yourself. You will be given a Research Medication Diary to record the drugs you take each day. You must bring the Research Medication Diary and any unused drugs with you to each study visit. You will also be told how to properly store the drugs.
On Days 1-3 of each cycle, you will give yourself an injection of omacetaxine every 12 hours (+/- 3 hours).
On Days 1-7 of each cycle, you will give yourself an injection of cytarabine every 12 hours (+/- 3 hours).
Each cycle will be 4-7 weeks, depending on how well the disease responds to the study drugs.
Depending on how the disease responds to the study drugs, the number of days you receive your injections may stay the same, increase, or decrease. Your doctor will discuss this with you.
Study Visits:
On Day 1 of each cycle, you will have a physical exam.
Women who are able to become pregnant must have a negative blood (about 1/2 teaspoon) or urine pregnancy test within 3 days before receiving the first dose of study drug.
Blood (about 1 tablespoon) will be drawn every week for routine tests. Once you have a response to treatment, blood will then be drawn every 2-4 weeks while you are receiving treatment. If your doctor thinks it is needed, you may have more blood samples drawn during Cycles 1 and 2.
On Day 21 of Cycle 1 (+/- 7 days), then every 4 weeks after that, you will have a bone marrow aspiration and/or biopsy to check the status of the disease. If the doctor thinks it is needed, these may be done more or less often, depending on your response to treatment.
Length of Study:
You may receive up to 24 cycles of treatment. You will be taken off study early if the disease gets worse or intolerable side effects occur.
Follow-up:
Once you stop taking the study drugs, you will have follow-up for 5 years.
Every 4-8 weeks, blood (about 1 tablespoon) will be drawn for routine tests. If you cannot return to the clinic, you may have blood drawn at a clinic close to your home.
Every 3-6 months, you will be contacted during a clinic visit and asked how you are doing. If you cannot make it to the clinic for this visit, you will be called. The phone call should last about 5 minutes.
This is an investigational study. Omacetaxine is FDA approved to treat patients with certain types of leukemia. Its use in this study is investigational. Cytarabine is FDA approved and commercially available for the treatment of AML. The use of these drugs in combination is investigational.
Up to 60 patients will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Omacetaxine and Cytarabine | Experimental | Drug: Omacetaxine, Drug: CytarabineOmacetaxine 1.25 mg/m2 SQ every 12 hours x 3 days + Cytarabine 20 mg SQ x 7 days of 4-7 week cycle. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Previously untreated AML (>/= 20% blasts). Patients with high-risk (intermediate-2 or high by International Prostate Symptom Score (IPSS) or ≥10% blasts) MDS will also be eligible. Prior therapy with hydroxyurea, biological or targeted therapy (e.g. flt3 inhibitors, other kinase inhibitors, azacitidine), or hematopoietic growth factors is allowed. A single or a two day dose of cytarabine (up to 3 g/m2) for emergency use is also allowed as prior therapy.
- Age >/= 60 years.
- Eastern Cooperative Oncology Group (ECOG) performance status </= 2.
- Adequate hepatic (serum total bilirubin </= 1.5 x ULN, serum glutamate pyruvate transaminase (SGPT) and/or serum glutamate oxaloacetate transaminase (SGOT) </= 2.5 x ULN) and renal function (creatinine </= 2.0 mg/dL).
- Patients must be willing and able to review, understand, and provide written consent before starting therapy.
Key exclusion criteria (7 listed)
- New York Heart Association (NYHA) class III or IV heart disease, active ischemia or any other uncontrolled cardiac condition such as angina pectoris, clinically significant cardiac arrhythmia and requiring therapy, uncontrolled hypertension (blood pressure >/= 160 systolic and >/= 110 diastolic not responsive to antihypertensive medication), diabetes mellitus, or congestive heart failure.
- Myocardial infarction in the previous 12 weeks (from the start of treatment).
- Active and uncontrolled disease/infection as judged by the treating physician.
- Pregnancy.
- Acute promyelocytic leukemia (APL).
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 |
|---|---|---|
| Omacetaxine1.25 mg/m2 subcutaneously (SQ) every 12 hours (+/- 3 hours) for 3 days (Days 1-3). Each cycle will be 4-7 weeks. | Drug | Omacetaxine and Cytarabine |
| CytarabineAlso: ARA-C, Cytosar, Depo-Cyt, Cytosine Arabinosine Hydrochloride20 mg subcutaneously every 12 hours (+/- 3 hours) for 7 days (Days 1-7). Each cycle will be 4-7 weeks. | Drug | Omacetaxine and Cytarabine |
Primary outcome
Percentage of Participants With Complete Remission (CR)
Time frame: Up to 4 months
Complete response (CR) defined as: Peripheral blood counts, no circulating blasts, neutrophil count ≥ 1.0 ×109/L, platelet count ≥ 100 ×109/L, bone marrow aspirate and biopsy, ≤5% blasts, no detectable auer rods, no extramedulary leukemia
4 secondary outcomes
Evaluation of CR Duration
Time frame: Up to 5 years after completion of active treatment and while on study. Participants may receive up to 24 courses of study medication.
Disease-free Survival
Time frame: Up to 5 years after completion of active treatment and while on study. Participants may receive up to 24 courses of study medication.
Overall Survival
Time frame: Up to 5 years after completion of active treatment and while on study. Participants may receive up to 24 courses of study medication.
Induction Mortality
Time frame: Up to 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 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.
Hagop Kantarjian, 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 Omacetaxine and Cytarabine 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 5 inclusion and 7 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 30 May 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 30 May 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?
Percentage of Participants With Complete Remission (CR) (time frame: Up to 4 months). 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 30 May 2018.