This trial is searching for patients to try a combination of glasdegib (Daurismo) with azacitidine (Vidaza) for acute myeloid leukemia (AML) that has not been treated. The main outcome that will be measured is overall survival.
Different anti-cancer drugs can be used in different combinations and may have different effects. Intensive treatment is usually aimed at killing cancer cells and involves strong chemotherapy. Non-intensive treatment is given to patients who might not be able to tolerate intensive therapy. Daunorubicin (Cerubidine), cytarabine (Depocyt) and azacitidine are chemotherapy drugs that may be used for AML. Glasdegib is a targeted therapy that blocks a certain protein on cancers cells. This blocks cancer cell survival. It is commonly used with cytarabine to prevent relapse. However, the effectiveness of glasdegib with less intense chemotherapy such as azacitidine is not known.
This study will investigate the effects of glasdegib with different combinations of chemotherapy. Overall survival will be measured in the 5 years after treatment.
Who are they looking for?
This study will enroll 720 participants. Participants must not have received treatment for AML in the 2 weeks before the study. Those of childbearing age must use contraception throughout the study and female patients should not be pregnant or breastfeeding. Patients should have adequate heart, kidney, and liver function tests.
Patients with acute promyelocytic leukemia or leukemia in the brain will not be included. Patients who have participated in another clinical trial in the 4 weeks before the start of this study will not be included. Those with conditions that may affect the absorption of the treatments may not be included. Patients with other cancers, active infections not related to AML, with substance abuse or psychiatric conditions will be excluded.
How will it work
Patients will undergo intensive or non-intensive treatment. Half of those undergoing intensive treatment will receive glasdegib every day for up to 2 years. The half that did not receive glasdegib will receive a placebo. This is identical to glasdegib but without the active ingredient. All participants in the intensive group will receive cytarabine for 7 days and daunorubicin for 3 days.
Those in the non-intensive group will receive azacitidine daily in 28 days cycles. They will also receive glasdegib or a placebo. This will continue until the cancer worsens, the participant experiences unacceptable side-effects or death. Patients will be followed up for 5 years.