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Venetoclax + Decitabine/Cedazuridine for Acute Myeloid Leukemia
Study Summary
This trial is studying a combination of drugs as a possible treatment for 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 haven't had cancer treatment in the last 7 days, except for specific cases approved by my doctor.I don't have severe stomach or metabolic issues affecting medication absorption.My leukemia is of a specific type known as acute promyelocytic (M3-AML).I can take care of myself and perform daily activities.I am 18 years old or older.I agree to avoid unprotected sex and not donate sperm for 90 days after my last dose.My white blood cell count is above the required level.I don't have active graft-versus-host disease after a stem cell transplant.I am not pregnant, nursing, or if capable of becoming pregnant, I agree to use contraception.My leukemia has returned or didn't respond to treatment, including if it's only outside the bone marrow.My leukemia is affecting my brain and is not well-controlled.I do not have any severe ongoing health issues like uncontrolled infections, high blood pressure, heart failure, or irregular heartbeats.I have an active hepatitis B, hepatitis C, or HIV infection.
- 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
Does this medical experiment have any vacancies for participants?
"Confirmed. Clinicaltrials.gov reveals that enrollment for this research project is currently underway, having been first announced on September 29th 2021 and most recently updated on July 17th 2022. 20 individuals need to be recruited from a single medical facility."
What maladies have Decitabine and Cedazuridine been proven to address?
"Refractory anemia is typically managed with Decitabine and Cedazuridine, though they may also be beneficial in treating conditions like chronic lymphocytic leukemia (CLL), intermediate-1 International Prognostic Scoring System risk category, and intermediate-2 IPSS risk category."
Has the FDA sanctioned Decitabine and Cedazuridine for therapeutic use?
"Our in-house experts have graded the safety of Decitabine and Cedazuridine to be a 2, as Phase 2 trials are yet to provide evidence of efficacy but there is some data that supports their safety."
What is the aggregate number of participants involved in this trial?
"Affirmative. Clinicaltrials.gov attests that this clinical trial is currently recruiting participants, having been originally posted on September 29th 2021 and last revised on July 17th 2022. 20 test subjects are required from a single medical site."
Have researchers previously conducted any experiments that incorporate Decitabine and Cedazuridine?
"At the present time, there are 304 clinical trials underway to evaluate Decitabine and Cedazuridine. 43 of these investigations fall within Phase 3 studies while 8584 medical sites across North America are running related experiments. Toronto is notably hosting many of these ongoing assessments."
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