A Phase Ib/II Open Label Dose Confirmation, Proof of Concept Study of Siremadlin in Combination With Venetoclax Plus Azacitidine in Unfit Adult AML Participants Who Responded Sub-optimally to First-line Venetoclax Plus Azacitidine Treatment and in Participants With Newly Diagnosed Unfit AML Presenting With High-risk Clinical Features
Latest Information Update: 22 May 2026
At a glance
- Drugs Azacitidine (Primary) ; Azacitidine (Primary) ; Siremadlin (Primary) ; Venetoclax (Primary)
- Indications Acute myeloid leukaemia
- Focus Adverse reactions; Proof of concept; Therapeutic Use
- Sponsors Novartis Pharmaceuticals
Most Recent Events
- 08 Jan 2025 Status changed from completed to discontinued. Reason: After enrolling 14 patients (6 patients in Arm 1 and 8 patients in Arm 2), Novartis took the decision to put the enrollment in permanent halt and terminate the siremadlin program. For that reason, the enrollment in Part 2 (expansion phase) did not open. This decision was not driven by any safety concerns.
- 13 Sep 2024 This trial has been Discontinued in Hungary (End date: 2024-04-17) according to European Clinical Trials Database record.
- 03 Jul 2024 Status changed from active, no longer recruiting to completed.