Venetoclax Combination Therapy for Acute Myeloid Leukemia
Trial Summary
What is the purpose of this trial?
The investigator is testing the addition of venetoclax to 5-azacitidine and vorinostat followed by standard chemotherapy to enhance treatment response in AML patients.
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications. However, if you are taking strong or moderate CYP3A4 inhibitors or P-glycoprotein inhibitors, your venetoclax dose may need to be adjusted. It's best to discuss your current medications with the study team.
What data supports the effectiveness of the drug combination therapy for acute myeloid leukemia?
Research shows that combining venetoclax with azacitidine improves remission rates and survival in patients with acute myeloid leukemia compared to azacitidine alone. Additionally, the combination of venetoclax with nucleoside analogs like low-dose cytarabine has led to significant response and survival outcomes in these patients.12345
Is Venetoclax combination therapy safe for treating acute myeloid leukemia?
Venetoclax combination therapy, often used with azacitidine, has shown acceptable safety in treating acute myeloid leukemia (AML), with common side effects including low blood cell counts (neutropenia, thrombocytopenia, and anemia). While some patients experience serious infections, the treatment is generally tolerable, especially when doses are managed carefully.678910
What makes the venetoclax combination therapy unique for treating acute myeloid leukemia?
The venetoclax combination therapy for acute myeloid leukemia is unique because it combines venetoclax with other drugs like azacitidine, cytarabine, and fludarabine, which have different mechanisms of action. This combination has shown improved response and survival rates compared to using azacitidine alone, especially in older or unfit patients.134711
Research Team
Michael Burke, MD
Principal Investigator
Medical College of Wisconsin
Eligibility Criteria
This trial is for AML patients who've relapsed or didn't respond to initial treatments. They must have recovered from previous therapies, have no severe infections or GVHD if post-transplant, and meet specific organ function criteria. Pregnant women can't participate, and contraception is required for those of childbearing potential.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive venetoclax, azacitidine, and vorinostat followed by standard chemotherapy over two 35-day cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Azacitadine
- Cytarabine
- Filgrastim
- Fludarabine
- Venetoclax
- Vorinostat
Azacitadine is already approved in United States, European Union for the following indications:
- Myelodysplastic Syndrome
- Acute Myeloid Leukemia
- Myelodysplastic Syndrome
- Acute Myeloid Leukemia
- Juvenile Myelomonocytic Leukemia
Find a Clinic Near You
Who Is Running the Clinical Trial?
Medical College of Wisconsin
Lead Sponsor