Azacitidine + Venetoclax + NK Cells for Acute Myeloid Leukemia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing if adding special immune cells from a healthy person to two existing cancer drugs can better control a type of blood cancer. The immune cells help fight cancer and infections. The two drugs work by killing cancer cells. These drugs have been used together to treat this type of blood cancer, showing improved response rates and survival compared to using one of the drugs alone.
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, it does mention that certain supportive care medications like hydroxyurea and cytarabine are allowed, and high-dose systemic steroids or immunosuppressive therapy should not be taken within a week of the first NK cell infusion.
Is the combination of Azacitidine, Venetoclax, and NK Cells safe for treating acute myeloid leukemia?
The combination of Azacitidine and Venetoclax has been studied for safety in patients with acute myeloid leukemia. Common side effects include blood-related issues and gastrointestinal problems, but the treatment is generally considered safe and tolerable for patients who are not fit for standard chemotherapy.12345
How is the drug combination of Azacitidine, Venetoclax, and NK Cells unique for treating acute myeloid leukemia?
This treatment is unique because it combines azacitidine and venetoclax, which are already used together to improve remission rates and survival in older or unfit patients with acute myeloid leukemia, with NK cells (natural killer cells) that may enhance the immune response against cancer cells.16789
What data supports the effectiveness of the treatment Azacitidine + Venetoclax + NK Cells for Acute Myeloid Leukemia?
Who Is on the Research Team?
Abhishek Maiti, MD
Principal Investigator
M.D. Anderson Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults diagnosed with Acute Myeloid Leukemia (AML) or related conditions, who have relapsed or don't respond to standard treatments. It's also open to older patients unfit for intensive chemotherapy. Participants must not have certain infections, severe heart issues, other active cancers, or be pregnant. They should agree to use contraception and understand the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Participants receive escalating doses of azacitidine, venetoclax, and allogeneic NK cells to evaluate safety and determine the optimal dose
Dose Expansion
Participants receive the combination of azacitidine, venetoclax, and allogeneic NK cells at the determined optimal dose to evaluate efficacy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Azacitidine
- NK Cells
- Venetoclax
Azacitidine is already approved in European Union, United States, Canada, Japan for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor