Venetoclax + Azacitidine for Acute Myeloid Leukemia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to understand how the immune system of patients with acute myeloid leukemia (AML) responds to a combination of two drugs: venetoclax (a targeted therapy) and azacitidine (a chemotherapy drug). By examining blood and bone marrow samples, researchers hope to gather information that could lead to better treatments in the future. The trial seeks adults newly diagnosed with AML who are receiving these two drugs as their first treatment. Eligible participants might be a good fit for this study. 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 advancements in AML therapy.
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 coordinators or your doctor.
What is the safety track record for venetoclax and azacitidine?
Research shows that patients generally tolerate the combination of venetoclax and azacitidine well. Studies have found that this treatment can be used safely. For instance, some patients experienced this combination without unexpected safety issues. In older patients with acute myeloid leukemia (AML), this treatment posed a lower risk of several side effects compared to other intensive treatments.
Another study found that patients with high-risk myelodysplastic syndromes (a group of disorders where blood cells are poorly formed or don't work properly) also handled this treatment well. This suggests that venetoclax plus azacitidine is a relatively safe option, with most side effects being predictable and manageable.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it aims to uncover how the combination of azacitidine and venetoclax affects the immune profile of patients with acute myeloid leukemia (AML). Unlike standard treatments that focus solely on eradicating cancer cells, this approach explores how these drugs may also engage the immune system, potentially offering more comprehensive treatment benefits. By collecting and analyzing blood and bone marrow samples, scientists hope to discover new insights into how these medications work together, which could lead to improved strategies for combating AML.
What evidence suggests that venetoclax plus azacitidine might be an effective treatment for acute myeloid leukemia?
Research has shown that combining venetoclax and azacitidine holds promise for treating acute myeloid leukemia (AML). Studies found that more than half of the patients went into remission, meaning their cancer was no longer detectable. In one study, patients lived for a median of 16.9 months, a positive outcome for AML. This drug combination also improved remission and survival rates compared to a placebo. Overall, these drugs offer a hopeful option for people with AML.12356
Who Is on the Research Team?
Talha Badar, M.D.
Principal Investigator
Mayo Clinic
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 venetoclax plus azacitidine induction chemotherapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Azacitidine
- Venetoclax
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients undergo blood sample collection and bone marrow aspirate on study. Patients' medical records are reviewed.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor
Citations
Outcomes of patients treated with venetoclax plus ...
Efficacy, including composite complete remission and overall survival, were improved with venetoclax plus azacitidine vs. placebo plus ...
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 ...
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%, ...
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.
6.
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 ...
Venetoclax (14 days) + azacitidine regimen was well tolerated in patients with treatment-naive HR MDS, with no unexpected safety findings. The ...
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