Azacitidine in Combination With Low Dose Intensity Venetoclax in Patients With AML Incl. Explorative AML Profiling
Status:
Recruiting
Trial end date:
2031-09-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 2
Details
Lead Sponsor:
Rigshospitalet, Denmark
Collaborators:
Haukeland University Hospital Helse Møre og Romsdal HF Helse Stavanger HF Helsinki University Central Hospital Karolinska University Hospital Kuopio University Hospital Oulu University Hospital Skane University Hospital St. Olavs Hospital Tampere University Hospital University Hospital of North Norway Uppsala University Hospital Vestre Viken Hospital Trust