Venetoclax + Azacitidine for Myelodysplastic Syndrome and Chronic Myelomonocytic Leukemia
What You Need to Know Before You Apply
What is the purpose of this trial?
This phase I/II trial investigates the side effects and best dose of venetoclax when given together with azacitidine and to see how well it works in treating patients with high-risk myelodysplastic syndrome or chronic myelomonocytic leukemia that has come back (relapsed) or has not responded to treatment (refractory). Venetoclax may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as azacitidine, 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. Giving venetoclax and azacitidine together may help to control myelodysplastic syndrome or chronic myelomonocytic leukemia.
Who Is on the Research Team?
Guillermo Garcia-Manero
Principal Investigator
M.D. Anderson Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults with high-risk myelodysplastic syndrome or chronic myelomonocytic leukemia that's resistant to treatment or has returned. They must have had previous unsuccessful therapy, be in good physical condition (ECOG/PS ≤2), and have proper liver and kidney function. Women of childbearing age need a negative pregnancy test and agree to contraception; men also must use birth control.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive venetoclax orally daily on days 1-14 and azacitidine intravenously or subcutaneously on days 1-5. Cycles repeat every 4-8 weeks in the absence of disease progression or unacceptable toxicity.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion, with follow-ups within 30 days and then every 3-6 months for up to 5 years.
What Are the Treatments Tested in This Trial?
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
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
National Cancer Institute (NCI)
Collaborator