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drugset / Trial / NCT05431257

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

NCT05431257 ↗

Phase 2 Recruiting 117 enrolled Rigshospitalet, Denmark Haukeland University Hospital · collabHelse Møre og Romsdal HF · collabHelse Stavanger HF · collabHelsinki University Central Hospital · collabKarolinska University Hospital · collabKuopio University Hospital · collabOulu University Hospital · collabSkane University Hospital · collabSt. Olavs Hospital · collabTampere University Hospital · collabUniversity Hospital of North Norway · collabUppsala University Hospital · collabVestre Viken Hospital Trust · collab
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2022-05-24
Primary completion
2031-09-01
Completion
2031-09-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Azacitidine Other / unclassified 75 mg/m2 —
Subject Venetoclax Small molecule 400 mg —

Indications

acute myeloid leukemia