This trial is examining the effectiveness of a new drug called uproleselan for patients with acute myeloid leukemia (AML). The main outcome to be measured will be overall survival. This study is being conducted in the United States.
Acute myeloid leukemia (AML) is a cancer of the bone marrow. It leads to an abnormal immune system. It is often treated with powerful medication such as chemotherapy and targeted therapy. However, many patients do not respond to these treatments or experience relapse. It is important to research new medications for these patients. Uproleselan is a new treatment being developed for AML. It works by interfering with the life of leukemia cells and enhancing chemotherapy response.
This study will evaluate the effectiveness of uproleselan combined with chemotherapy compared to chemotherapy alone in patients with relapsed or unresponsive AML. The main outcome to be measured will be overall survival 5 years after treatment.
Who are they looking for?
This study will recruit 380 participants. Patients should not have had more than one stem cell transplant. They also should not have received chemotherapy with mitoxantrone, etoposide, and cytarabine (MEC) or with fludarabine, cytarabine, and idarubicin (FAI).
Patients should not have brain cancer or a stem transplant in the last 4 months. Any immunotherapy or radiotherapy should have stopped within 28 days of study treatment and chemotherapy within 14 days. Patients should not have abnormal kidney or liver function, any life-threatening infection or heart disease. Patients must not have had any major surgery within 4 weeks of study treatment or immunostimulants within 7 days of study treatment.
How will it work
There will be two groups in this study. One group will receive uproleselan with chemotherapy (MEC or FAI). The other group will receive a placebo (salt water) with the same chemotherapy.
Patients will be followed for up to 5 years after treatment. Overall survival, length of time without signs of disease, and drug side effects will be measured.