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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

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Trial Profile

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

Status: Discontinued
Phase of Trial: Phase I

Latest Information Update: 13 Jan 2025

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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.
  • 08 Jan 2025 According to ClinicalTrials.gov,After enrolling 14 patients, Novartis decided to permanently halt enrollment and terminate the siremadlin program. Consequently, enrollment for Part 2 did not commence. This decision was not influenced 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.

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