This trial is comparing the safety and effectiveness of venetoclax (Venclexta) and azacitidine (Vidaza) with azacitidine alone in patients with acute myeloid leukemia (AML). The main outcome to be measured will be overall survival. Complete remission (no signs of cancer after treatment) will also be measured.
Acute myeloid leukemia (AML) is a type of cancer of the bone marrow. It can lead to an abnormal immune system and abnormal immune cells. It is often treated with strong chemotherapy drugs.
This trial will evaluate the safety and effectiveness of azacitidine and venetoclax combination in previously untreated patients with AML. The main outcomes to be measured will be overall survival and complete remission.
Who are they looking for?
400 patients will be recruited for this study. Patients should have untreated AML and not suitable for treatment with standard chemotherapy. Subjects must have adequate liver and kidney functions. Women of childbearing age must agree to use birth control for the study period and another 90 days after. Sexually active males with female partners of childbearing potential should also user contraception or abstain from sexual intercourse or donating sperm up to 90 days after the last study dose.
Patients should not be pregnant or have received treatment for AML before. Patients must not have brain involvement, a previous history of cancer, HIV, heart disease or active infections.
How will it work
There will be two groups in this study. The first group will receive a placebo tablet once a day, followed by azacitidine. The second group will receive venetoclax tablet once a day followed by azacitidine. Azacitidine will be given as an injection into the vein or under the skin on days 1 to 7, in 28-days cycle.
Patients will have overall survival and complete remission measured up to 2 years.