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Venetoclax + ASTX727 for Acute Myeloid Leukemia
Study Summary
This trial studies the possible benefits of venetoclax and ASTX727 in treating patients with acute myeloid leukemia.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am 75 years old or older.I agree to use birth control during and for 3 months after the study ends.I can take hydroxyurea for my fast-growing disease before and during the first cycle of the study, if needed.I can take care of myself but might not be able to do heavy physical work.My liver function is moderately impaired.I am not eligible for initial standard cancer treatment.My AML has not responded to or has come back after previous treatment.My kidneys work well enough, with a creatinine clearance of 45 ml/min or more.I am not able to have children, am postmenopausal, or have a negative pregnancy test.I am 18 years old or older.I am 18-74 years old with a serious health condition like heart failure or lung problems.I have been recently diagnosed with acute myeloid leukemia (AML).I have been treated with a BCL2 inhibitor before.I have symptoms or uncontrolled leukemia in my brain or spinal cord.I do not have any severe ongoing health issues that are not under control.I have been diagnosed with acute promyelocytic leukemia.My kidney function is low but not critically so.
- Group 1: Treatment (decitabine and cedazuridine, venetoclax)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Could you explain the hazards associated with Decitabine and Cedazuridine for those undergoing treatment?
"Our team at Power assigned Decitabine and Cedazuridine a score of 2 in terms of safety, since it is only approved for Phase 2 trials which indicates some evidence of safety but no confirmation on efficacy."
What have been the outcomes of previous tests concerning Decitabine and Cedazuridine?
"Currently, 303 trials are running with Decitabine and Cedazuridine as the primary focus. Of those, 43 have entered Phase 3. While Edmonton, Alberta is home to most of these studies, there are 8631 sites all over the world offering this treatment option."
What is the current enrollment for this research endeavor?
"Affirmative. By checking clinicaltrials.gov, we can ascertain that this medical trial is enlisting new patients and was first submitted on February 22nd 2021. At the moment, 40 participants are required from a single site before December 7th 2022."
Is there space available for volunteers to participate in this trial?
"Current information on clinicaltrials.gov affirms that this research project is actively recruiting individuals for participation. The trial was first announced in February 2021 and the most recent update to its data occurred in December 2022."
For what conditions are Decitabine and Cedazuridine typically utilized?
"Decitabine and Cedazuridine are both effective therapies for refractory anemia, intermediate-1 International Prognostic Scoring System (IPSS) risk category, and chronic lymphocytic leukemia."
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