Azacitidine + Venetoclax for Acute Myeloid Leukemia
Trial Summary
What is the purpose of this trial?
This phase II trial studies how well azacitidine and venetoclax work in treating patients with acute myeloid leukemia that is in remission. Drugs used in chemotherapy, such as azacitidine and venetoclax, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
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 is common for clinical trials to have specific requirements, so it's best to discuss your current medications with the trial coordinators.
Will I have to stop taking my current medications?
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 data supports the idea that Azacitidine + Venetoclax for Acute Myeloid Leukemia is an effective drug?
The available research shows that the combination of Azacitidine and Venetoclax is effective for treating Acute Myeloid Leukemia, especially in older patients or those who cannot undergo intensive chemotherapy. One study found that this combination improved remission rates and survival compared to Azacitidine alone. Another study reported that patients receiving this combination had a significant increase in overall survival compared to those receiving a placebo with Azacitidine. Additionally, in a study conducted in Latin America, patients with newly diagnosed Acute Myeloid Leukemia had a high response rate, with 78.6% showing improvement, and a median survival of 9.6 months. These findings suggest that Azacitidine and Venetoclax together are a promising option for treating this condition.12345
What data supports the effectiveness of the drug combination Azacitidine and Venetoclax for treating acute myeloid leukemia?
Research shows that the combination of Azacitidine and Venetoclax improves remission rates and survival in older or unfit patients with acute myeloid leukemia compared to Azacitidine alone. Additionally, a study in Latin America found that this drug combination had favorable response rates and survival outcomes in both newly diagnosed and relapsed patients.12345
What safety data is available for Azacitidine and Venetoclax in treating Acute Myeloid Leukemia?
The safety of Azacitidine and Venetoclax (Ven+AZA) in treating Acute Myeloid Leukemia (AML) has been evaluated in several studies. Common hematologic toxicities were reported, but the treatment was generally tolerable. In a study conducted in Latin America, hematologic toxicities were common, but the treatment was effective with a complete response rate of 78.6% in newly diagnosed patients. Another study in China found that Ven+AZA was tolerable for AML patients, with a high response rate and some achieving minimal residual disease negativity. The treatment was effective in patients with specific genetic mutations like NPM1, IDH1/IDH2, and TP53. Overall, the safety profile is considered acceptable, but long-term efficacy and safety remain to be observed.13567
Is the combination of Azacitidine and Venetoclax safe for treating acute myeloid leukemia?
Is the drug combination of Azacitidine and Venetoclax a promising treatment for Acute Myeloid Leukemia?
How is the drug combination of Azacitidine and Venetoclax unique for treating acute myeloid leukemia?
The combination of Azacitidine and Venetoclax is unique because it is specifically used for older patients or those who cannot undergo intensive chemotherapy, improving remission rates and survival compared to Azacitidine alone. This combination is particularly beneficial for patients who are newly diagnosed and considered unfit for standard intensive treatments.12348
Research Team
Tapan Kadia, MD
Principal Investigator
M.D. Anderson Cancer Center
Eligibility Criteria
This trial is for adults over 18 with Acute Myeloid Leukemia (AML) in their first remission who aren't going for a stem cell transplant right away. They must have finished induction therapy and at least one consolidation cycle if they had intensive treatment, or two cycles of lower intensity therapy. Participants need to be healthy enough overall, not pregnant or breastfeeding, willing to use contraception, and without certain other serious illnesses.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive azacitidine subcutaneously or intravenously over 1 hour daily on days 1-5, and venetoclax orally daily on days 1-14. Treatment repeats every 28 days for up to 24 cycles.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion, with follow-ups at 30 days and then every 6-12 months.
Treatment Details
Interventions
- Azacitidine
- Venetoclax
Azacitidine is already approved in European Union, United States, Canada, Japan for the following indications:
- Acute myeloid leukemia
- Chronic myelomonocytic leukemia
- Myelodysplastic syndromes
- Myelodysplastic syndromes
- Chronic myelomonocytic leukemia
- Myelodysplastic syndromes
- Acute myeloid leukemia
- Myelodysplastic syndromes
- Acute myeloid leukemia
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
Genentech, Inc.
Industry Sponsor
Ashley Magargee
Genentech, Inc.
Chief Executive Officer since 2024
MBA from Harvard University, BA from Princeton University
Levi Garraway
Genentech, Inc.
Chief Medical Officer since 2021
MD, PhD