Venetoclax + Decitabine for Acute Myeloid Leukemia
Trial Summary
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, oral hydroxyurea and one dose of cytarabine are allowed before and during the study, and you should discuss any other medications with the principal investigator.
What data supports the effectiveness of the drug combination Venetoclax and Decitabine for treating Acute Myeloid Leukemia?
Research shows that combining Venetoclax with Decitabine is effective for older patients with acute myeloid leukemia (AML) who cannot undergo intensive chemotherapy. In a study, 67% of patients achieved complete remission, and the combination led to longer survival compared to Decitabine alone.12345
Is the combination of Venetoclax and Decitabine safe for humans?
The combination of Venetoclax and Decitabine has been studied in elderly patients with acute myeloid leukemia (AML) and is generally well tolerated. Common side effects include nausea, diarrhea, constipation, fatigue, and low white blood cell count, but no severe tumor lysis syndrome (a serious condition caused by the rapid breakdown of cancer cells) was observed.12367
What makes the drug combination of Venetoclax and Decitabine unique for treating acute myeloid leukemia?
What is the purpose of this trial?
This phase II trial studies how well venetoclax and decitabine work in treating participants with acute myeloid leukemia that has come back or does not respond to treatment, or with high-risk myelodysplastic syndrome that has come back. Drugs used in chemotherapy, such as venetoclax and decitabine, 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.
Research Team
Abhishek Maiti, MD
Principal Investigator
M.D. Anderson Cancer Center
Eligibility Criteria
This trial is for adults under 60 with newly diagnosed AML or high-risk MDS, not responding to treatment or relapsed. Participants must have adequate liver and kidney function, not be pregnant or breastfeeding, agree to use contraception if of childbearing potential, and cannot have certain blood cancers (like acute promyelocytic leukemia) or uncontrolled medical conditions.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive decitabine IV over 1 hour on days 1-10 and venetoclax PO daily on days 1-28 of cycle 1 and on days 1-21 of subsequent cycles. Treatment repeats every 28 days for up to 24 cycles.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion
Treatment Details
Interventions
- Decitabine
- Venetoclax
Decitabine is already approved in European Union, United States, Canada, Japan for the following indications:
- Acute myeloid leukemia
- Myelodysplastic syndromes
- Myelodysplastic syndromes
- Acute myeloid 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