This study is evaluating how well CPI-613 plus chemotherapy works in older patients with acute myeloid leukemia (AML) that has come back or stopped responding to treatment. The main outcome to be measured will be the number of patients who have a complete disappearance of all signs of cancer. This trial is taking place across the United States.
Acute myeloid leukemia is a cancer of the blood and bone marrow. For patients with recurrent AML, treatment may include targeted therapy or combination chemotherapy. CPI-613 (Devimistat) is a new targeted therapy. This type of treatment specifically targets cancer cells. CPI-613 blocks energy production in cancer cells and makes them more sensitive to chemotherapy. Combining this new agent with chemotherapy may help lower side effects compared to chemotherapy alone.
This study is evaluating how well CPI-613 plus chemotherapy works in older patients with recurrent or non-responsive AML. The main outcome to be measured will be the number of patients who have complete remission after treatment.
Who are they looking for?
This study is recruiting 500 patients with AML that has come back or stopped responding to treatment. All patients with reproductive potential must agree to use contraception during treatment, and for 6 months after finishing treatment. Patients should not have any anti-cancer therapy within 2 weeks before starting the study treatment. Patients should have adequate coagulation, liver and kidney function.
Patients who have previously received chemotherapy for relapsed or unresponsive disease cannot participate. Patients with uncontrolled bleeding or infections, heart failure, or severe lung disease cannot participate. Patients with cancer in the brain or spinal cord cannot participate. Patients with a history of another cancer within the past 5 years cannot participate. The only exceptions to this include patients with stage 1 prostate cancer or patients who have no signs of cancer after being treated.
How will it work
This study will involve two groups of patients. In the first group, patients will receive the study treatment (CPI-613) plus HAM (high-dose cytarabine, mitoxantrone) chemotherapy. In the second group, patients will receive HAM chemotherapy only.
The main outcome to be measured will be the number of patients who have complete remission after treatment. The number of patients who remain alive for at least 12 months after treatment will also be measured.