This research study is a Phase II clinical trial. Phase II clinical trials test the
effectiveness of an investigational drug to learn whether the drug is effective in treating a
specific cancer. "Investigational" means that sulindac is still being studied and that
research doctors are trying to find out more about it. It also means that the FDA has not yet
approved the use of sulindac for your type of cancer.
Participants in this study must have undergone previous chemotherapy and achieved complete
remission, which is the absence of disease activity in people with a chronic illness, in this
case AML. Unfortunately, a significant number of patients with AML who achieve a complete
remission with initial chemotherapy eventually experience a relapse, often within a few
months.
Previous research studies have demonstrated that a type of medication frequently used to
treat inflammation, called a COX inhibitor, may suppress and kill leukemia cells. COX
inhibitors work by blocking a class of proteins called COX proteins. Other commonly used COX
inhibitors are ibuprofen and naproxen.
For this study, the investigators are using a COX inhibitor called sulindac, which has been
FDA approved and used to treat pain and inflammation for many years, and has also been
studied in suppressing certain tumors of the gastrointestinal system. The main goal of this
study is to determine whether sulindac can help participants remain in a state of complete
remission following the initial course of chemotherapy for AML, and two cycles of
chemotherapy that is standard of care for your cancer, called consolidation chemotherapy.
During the course of this study, the investigators will also attempt to learn more about how
COX inhibition suppresses the emergence of leukemia, at the molecular and cellular level, by
studying the participants on this trial.