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Venetoclax + Decitabine for Acute Myeloid Leukemia
Study Summary
This trial is testing an experimental drug to see if it is safe and effective when given to people with a specific type of 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.Side effects data
From 2022 Phase 3 trial • 389 Patients • NCT02005471Trial Design
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Who is running the clinical trial?
Media Library
- I have been diagnosed with acute promyelocytic leukemia.My leukemia has spread to my brain or spinal cord.My AML is considered high risk.I am not taking any strong medications that affect liver enzymes.My condition has returned or didn't respond to treatment.My leukemia is TP53 mutant.I am ready and able to undergo strong chemotherapy.I am 18 years old or older.I haven't taken any experimental cancer drugs or treatments in the last 2 weeks.I am on steroids for cancer treatment.My organs are functioning well.I have AML with a TP53 mutation and haven't been treated for it yet.I need treatment for chronic hepatitis B or C.I have previously been treated with venetoclax, decitabine, or azacitidine.I have a history of heart failure or my heart pumps less effectively.I can take care of myself and am up and about more than 50% of my waking hours.I have heart disease that causes symptoms like fatigue or chest pain with normal activity.I have recovered from any major surgery or radiation therapy I had more than 2 weeks ago.I am not receiving any cancer treatments not listed in this study's protocol.My kidneys are functioning well enough, as shown by tests.I do not have an active or uncontrolled infection.I do not have another cancer needing treatment within 6 months.My cancer has specific genetic features considered high-risk.I am in the first phase of the trial, focusing on finding the right dose.My heart condition limits my physical activity significantly.I haven't taken any excluded medications in the last week.I am a woman who can have children and my pregnancy test is negative.I have a history of heart problems.I have AML with a TP53 mutation and haven't been treated for it yet.I am in the dose expansion phase of a Phase 2 clinical trial.I do not have any uncontrolled health conditions.I haven't taken any excluded medications or substances in the last 3 days.
- Group 1: Treatment
- 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
What are the potential adverse effects of Venetoclax for patients?
"The safety of Venetoclax was judged to be a 1 due to the Phase 1 nature of the trial, which means that there is scarce evidence for its efficacy and security."
What is the current sample size of this therapeutic research?
"Affirmative. Information found on clinicaltrials.gov confirms that this investigation is currently accepting new participants; the trial was originally posted November 18th 2019, and last updated May 16th 2022. The study requires 26 individuals to be recruited from one medical site."
Are there any documented precedents of research into Venetoclax?
"Presently, the existing body of work on Venetoclax spans 302 active trials with 42 in Phase 3. Several studies are being conducted in Edmonton, Alberta; however, this drug is currently under study at 8576 different sites worldwide."
What applications has Venetoclax demonstrated efficacy in?
"Venetoclax is often prescribed to treat refractory anemia, as well as other ailments such as chronic lymphocytic leukemia (CLL), intermediate-1 and intermediate-2 levels of International Prognostic Scoring System (IPSS) risk."
Are there any vacancies left to join this medical trial?
"As indicated on clinicaltrials.gov, this medical trial is still open to enrolment and has been since November 18th 2019. It was last revised on May 16th 2022."
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