Galinpepimut-S Versus Investigator's Choice of Best Available Therapy for Maintenance in AML CR2/CRp2

To join this study, you need to be an adult, aged 18 or older. You must have been diagnosed with Acute Myeloid Leukaemia (AML) and have achieved your second or later remission. This means your cancer has improved significantly and there are very few or no leukaemia cells in your bone marrow, and your blood counts are improving.

It's important that you are not currently eligible for a stem cell transplant, perhaps due to other health issues, your own preference, or because a suitable donor isn't available. Your last dose of anti-leukaemia treatment must have been at least 4 weeks ago, and you must have been in your current remission for no longer than 6 months when you agree to join the study.

Your general health and ability to carry out daily activities will also be checked, and you should have an estimated life expectancy of more than 6 months. Women who could become pregnant will need a negative pregnancy test and agree to use effective contraception.

If you join this study, you'll be assigned by chance to one of two groups. One group will receive the new treatment, galinpepimut-S, and the other will receive a standard treatment chosen by your doctor. The galinpepimut-S treatment involves injections every two weeks for six doses, followed by a break, and then another six doses every four weeks.

Before each galinpepimut-S injection, you'll also receive another injection called GM-CSF. If you're in the standard treatment group, your doctor will decide which of the usual treatments (like observation, azacitidine, decitabine, venetoclax, or cytarabine) is best for you. During the study, you'll have regular appointments for check-ups, blood tests, and possibly bone marrow samples, to monitor your health and how the treatment is working. We don't have the exact total duration but similar long-term follow up are expected for studies like this.