This trial is investigating the effectiveness of adding chemotherapy drug venetoclax to a standard chemotherapy treatment for patients with acute myelogenous leukemia (AML). The main outcome for this study would be the maximum amount of the drug that gives the most benefits to patients and the effectiveness of the drug. This study is recruiting in Boston, MA.
AML is a type of cancer that affects white blood cells that fight infection. Newly diagnosed patients are generally given chemotherapy to fight the cancer. This chemotherapy usually involves daunorubicin (Cerubidine) and cytarabine (Cytosar-U). A newer chemotherapy drug called venetoclax (Venclexta) could help fight AML cancer cells also by causing them to die.
The purpose of this study is to see if venetoclax makes standard chemotherapy more powerful at killing cancer cells. The main outcomes will be to measure the amount of venetoclax that gives the most benefits to patients and how effective the drug is.
Who are they looking for?
This study is recruiting 64 patients with newly diagnosed AML. Patients must be aged between 18-60 and have good kidney, heart and liver function. Male patients must agree to refrain from unprotected sex or sperm donation during the trial. Female patients of childbearing age must not be pregnant at the start of the trial.
Patients with leukemia in the brain or spine cannot participate. Patients with certain infections (such as HIV or Hepatitis B or C) cannot participate. Patients that have taken drugs acting on CYP3A 7 days before the start of the study cannot participate. Patients with a history of certain diseases, including some cancers, cannot participate. Patients with heart disease that impacts their physical activity cannot participate. Patients who received chemotherapy, immunotherapy or treatment with a new drug 1 month before the trial cannot participate.
How will it work
All patients in this study will receive venetoclax orally with standard chemotherapy drugs daunorubicin and cytarabine.
Patients will be monitored for 2 years to see which amount of venetoclax gives the most benefits. The effectiveness (response to treatment) of the drug will also be monitored for 2 years after the study has ended.