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DNA Methyltransferase Inhibitor
Omacetaxine + Azacitidine for Myelodysplastic Syndrome
Phase 1 & 2
Waitlist Available
Led By Daniel Pollyea, MD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject must have confirmation of high grade MDS (MDS with excess blasts by WHO criteria) or chronic myelomonocytic leukemia with greater than 5% bone marrow blasts
Subject must have an Eastern Cooperative Oncology Group (ECOG) Performance status of ≤2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up study start date to study end date, or death, whichever comes first, up to 4 years.
Awards & highlights
Study Summary
This trial will test a new combination of drugs to treat patients with MDS who have not responded to other treatments.
Who is the study for?
This trial is for adults over 18 with high grade myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia who haven't been treated before, or have tried a treatment but it didn't work. They should be relatively healthy otherwise, with good kidney and liver function, and not have other serious illnesses or active infections.Check my eligibility
What is being tested?
The study tests the combination of two drugs, omacetaxine mepesuccinate and azacitidine, in treating patients with untreated high-grade MDS. It aims to see how well these drugs work together as an initial therapy or after other treatments failed.See study design
What are the potential side effects?
Potential side effects may include fatigue, nausea, bleeding problems due to low platelet counts, increased risk of infection from low white blood cell counts, and possible liver issues indicated by changes in certain blood tests.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My condition is either high-grade MDS or chronic leukemia with more than 5% bone marrow blasts.
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I can take care of myself and am up and about more than half of my waking hours.
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I am 18 years old or older.
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My liver tests are within normal limits.
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My kidneys work well enough, with a creatinine clearance rate of at least 30 mL/min.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ start of study to end of study, for up to four years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~start of study to end of study, for up to four years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Response Rate
Recommended Dose
Secondary outcome measures
Duration of Response
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).
Overall Survival
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Phase IIExperimental Treatment2 Interventions
Up to 33 patients will be enrolled to receive the maximum tolerated dose (determined in phase I) over a 28 day cycle. Azacitidine will be given at the standard dose over a 28 day cycle.
Group II: Phase IExperimental Treatment2 Interventions
Up to 18 patients will be enrolled to one of three cohorts to receive various doses of omacetaxine over a 28 day cycle. Azacitidine will be given at the standard dose over a 28 day cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Omacetaxine mepesuccinate
FDA approved
Azacitidine
FDA approved
Find a Location
Who is running the clinical trial?
University of Colorado, DenverLead Sponsor
1,732 Previous Clinical Trials
2,143,554 Total Patients Enrolled
Daniel Pollyea, MDPrincipal InvestigatorUniversity of Colorado, Denver
4 Previous Clinical Trials
118 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My condition is either high-grade MDS or chronic leukemia with more than 5% bone marrow blasts.I can take care of myself and am up and about more than half of my waking hours.I am 18 years old or older.I agree to use two forms of birth control or abstain from sex as required.My liver tests are within normal limits.I agree to use birth control and not donate sperm until 90 days after my last dose.My kidneys work well enough, with a creatinine clearance rate of at least 30 mL/min.I had cancer before, but it was either skin cancer, treated breast or cervical cancer, prostate cancer not needing treatment, or any cancer that was completely removed or treated.I have hepatitis B or C, but my viral load is undetectable.
Research Study Groups:
This trial has the following groups:- Group 1: Phase I
- Group 2: Phase II
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
For what purpose is Azacitidine typically prescribed?
"Azacitidine can be used as an effective treatment for induction chemotherapy, refractory anemias, and leukemia, myelocytic, acute."
Answered by AI
What are the investigators hoping to learn from this research?
"The main objective of this trial is to monitor the Overall Response Rate over a period of four years. Secondary objectives include Progression Free Survival, Duration of Response, and Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability])."
Answered by AI
Can new patients still sign up for this research project?
"Yes, as of today this trial is still recruiting patients. The original posting was on September 17th, 2018 with the latest update being October 19th, 2021."
Answered by AI
Do we have any prior data to draw upon regarding Azacitidine?
"There are currently 183 ongoing clinical trials investigating the use of azacitidine, 33 of which are in Phase 3. While several trials for azacitidine are located in Houston, Texas, there are a total of 5735 locations worldwide where clinical trials for azacitidine are taking place."
Answered by AI
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