Azacitidine in Combination With Low Dose Intensity Venetoclax in Patients With AML Incl. Explorative AML Profiling

Multi-center phase II study of standard azacytidine treatment (AZA; D1-D7, 75mg/m2 qd) in combination with a short duration of "low-dose" venetoclax treatment (LD-VEN; D1-D14 before CR and D1-D7 after CR, 400mg qd) per 28 days cycle for elderly/unfit (arm 1) and relapsed/refractory (arm 2) patients with acute myeloid leukemia. AZA and LD-VEN treatment is combined with exploratory AML profiling using established platforms for OMICs analyses and ex vivo drug sensitivity and resistance testing. This will validate the feasibility of AML profiling in a clinical setting to predict responders and non-responders to AZA/LD-VEN therapy. The exploratory AML profiling program will also identify biomarkers as well as novel drugs and drug combinations applicable for treatment of AML patients in future clinical trial initiatives.

NCT Number	NCT05431257
Lead Sponsor	Rigshospitalet, Denmark Collaborators: Helse Stavanger HF, University Hospital of North Norway, Haukeland University Hospital, St. Olavs Hospital, Vestre Viken Hospital Trust, Helse Møre og Romsdal HF, Karolinska University Hospital, Skane University Hospital, Uppsala University Hospital, Helsinki University Central Hospital, Oulu University Hospital, Tampere University Hospital, Kuopio University Hospital
Conditions	Acute Myeloid Leukemia
Enrollment	117 participants
Start Date	2022-05-24
Primary Completion	2031-09-01 (estimated)
Study Completion	2031-09-01 (estimated)
Updated on ClinicalTrials.gov	2022-06-24