Azacitidine + Venetoclax for Acute Myeloid Leukemia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how genetic differences affect the side effects and success of two medications, azacitidine (a chemotherapy drug) and venetoclax (a targeted therapy), in treating acute myeloid leukemia (AML). By studying these genetic variations, researchers aim to understand why reactions and outcomes vary among individuals using these drugs. Participants with AML who are receiving or planning to start treatment with azacitidine and venetoclax may be suitable candidates.
As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that patients generally tolerate the combination of azacitidine and venetoclax well. Studies have found that this treatment can be used safely, even at lower doses, in various situations. Reports suggest that patients usually experience fewer severe side effects compared to more intense treatments.
One study found the combination to be as safe as standard care, with fewer reports of serious negative side effects. While side effects can still occur, they are often less severe than with other treatments.
Overall, evidence suggests that azacitidine and venetoclax are safe for many patients, but individual experiences can vary. Discuss potential side effects with a healthcare provider before joining a trial.12345Why are researchers excited about this trial?
Researchers are excited about the combination of azacitidine and venetoclax for treating acute myeloid leukemia (AML) because this duo works differently than standard chemotherapy options. Azacitidine is a hypomethylating agent that can alter the expression of genes involved in cancer cell growth, while venetoclax targets and inhibits BCL-2, a protein that helps cancer cells survive. This targeted approach aims to enhance the destruction of leukemia cells with potentially fewer side effects compared to traditional treatments. Additionally, the combination's focus on genetic and pharmacogenomic factors could lead to personalized treatment strategies, offering hope for improved outcomes.
What evidence suggests that azacitidine and venetoclax could be effective for AML?
Research has shown that combining azacitidine and venetoclax effectively treats acute myeloid leukemia (AML). In one study, more than half of the patients went into remission, meaning the cancer was no longer detectable. Another study found that patients receiving this combination lived longer than those given a placebo. This treatment also demonstrated better overall response rates compared to other options. In this trial, participants will receive the combination of azacitidine and venetoclax, which has consistently shown positive results, offering hope for those with AML.12346
Who Is on the Research Team?
Brittany Ragon, MD
Principal Investigator
Atrium Health Wake Forest Baptist Comprehensive Cancer Center
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive azacitidine and venetoclax as standard of care, with buccal swabs collected for SNPs and pharmacogenomic analysis. Venetoclax peak and trough levels are obtained.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including toxicity side effects and disease response.
What Are the Treatments Tested in This Trial?
Interventions
- Azacitidine
- Venetoclax
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Buccal swabs for SNPs and pharmacogenomic analysis can occur at any point before or after starting treatment during the study period. Venetoclax peak and trough levels will be obtained during SOC Aza/Ven treatments. CYP3A activity will also be evaluated. Demographic and cancer related history will be acquired for each participant. During study participation, cancer treatment details including administration, dose modifications, delays, and reductions, including specific grade 3 toxicities, stem cell transplant status, symptom burden, disease response, and survival will be collected. Participants will be taken off study after three years.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Wake Forest University Health Sciences
Lead Sponsor
Swim Across America
Collaborator
Atrium Health Levine Cancer Institute
Collaborator
Swim Across America
Collaborator
Citations
Real-world outcomes of azacitidine plus venetoclax in ...
After treatment, more than half went into remission (the cancer was no longer detectable), and those with newly diagnosed AML had better ...
Outcomes of patients treated with venetoclax plus ...
Efficacy, including composite complete remission and overall survival, were improved with venetoclax plus azacitidine vs. placebo plus ...
Azacitidine and Venetoclax in Previously Untreated Acute ...
At a median follow-up of 14.9 months, the median overall survival was 16.9 months. This confirmatory trial (VIALE-A) was designed to evaluate ...
4.
hematologyadvisor.com
hematologyadvisor.com/news/combination-azacitidine-venetoclax-acute-myeloid-leukemia-aml-treatment-risk/Combination Azacitidine, Venetoclax Effective in AML ...
Analysis showed that the overall response rates in the azacitidine plus venetoclax, chemotherapy, and azacitidine monotherapy groups were 38.5%, ...
5.
ashpublications.org
ashpublications.org/blood/article/145/11/1126/534406/Efficacy-and-safety-of-venetoclax-plus-azacitidineEfficacy and safety of venetoclax plus azacitidine for patients ...
As of May 2023, 107 patients received venetoclax and azacitidine combination at the RP2D. Best response of CR or marrow CR was observed in 29.9% ...
Comparative safety and effectiveness of azacitidine plus ...
In AML patients aged 60–75 years, HMA&Ven demonstrated comparable all-cause mortality to IC and significantly lower risk of several adverse events.
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