A Study of Siremadlin in Combination With Venetoclax Plus Azacitidine in Adult Participants With Acute Myeloid Leukemia (AML) Who Are Ineligible for Chemotherapy.
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
Sponsor: Novartis Pharmaceuticals
Terminated
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.
Other terminated trials from Novartis Pharmaceuticals
Other Acute Myeloid Leukemia trials with similar outcome
Listed as NCT05155709, this PHASE1 trial focuses on Acute Myeloid Leukemia and remains terminated or withdrawn. Sponsored by Novartis Pharmaceuticals, it has been updated 28 times since 2022, reflecting substantial change activity. This study contributes to the evolving evidence base for cancer treatment protocols.
Status Flow
Change History
28 versions recorded-
Nov 2025 — Present [monthly]
Terminated PHASE1
-
Sep 2025 — Nov 2025 [monthly]
Terminated PHASE1
-
May 2025 — Sep 2025 [monthly]
Terminated PHASE1
-
Apr 2025 — May 2025 [monthly]
Terminated PHASE1
-
Feb 2025 — Apr 2025 [monthly]
Terminated PHASE1
Status: Completed → Terminated
▶ Show 23 earlier versions
-
Sep 2024 — Feb 2025 [monthly]
Completed PHASE1
-
Aug 2024 — Sep 2024 [monthly]
Completed PHASE1
Status: Active Not Recruiting → Completed
-
Jul 2024 — Aug 2024 [monthly]
Active Not Recruiting PHASE1
-
Jun 2024 — Jul 2024 [monthly]
Active Not Recruiting PHASE1
Phase: PHASE1_PHASE2 → PHASE1
-
Apr 2024 — Jun 2024 [monthly]
Active Not Recruiting PHASE1_PHASE2
-
Mar 2024 — Apr 2024 [monthly]
Active Not Recruiting PHASE1_PHASE2
Status: Recruiting → Active Not Recruiting
-
Oct 2023 — Mar 2024 [monthly]
Recruiting PHASE1_PHASE2
-
Sep 2023 — Oct 2023 [monthly]
Recruiting PHASE1_PHASE2
-
Aug 2023 — Sep 2023 [monthly]
Recruiting PHASE1_PHASE2
-
Jul 2023 — Aug 2023 [monthly]
Recruiting PHASE1_PHASE2
-
Jun 2023 — Jul 2023 [monthly]
Recruiting PHASE1_PHASE2
-
May 2023 — Jun 2023 [monthly]
Recruiting PHASE1_PHASE2
-
Apr 2023 — May 2023 [monthly]
Recruiting PHASE1_PHASE2
-
Feb 2023 — Apr 2023 [monthly]
Recruiting PHASE1_PHASE2
-
Jan 2023 — Feb 2023 [monthly]
Recruiting PHASE1_PHASE2
-
Nov 2022 — Jan 2023 [monthly]
Recruiting PHASE1_PHASE2
-
Sep 2022 — Nov 2022 [monthly]
Recruiting PHASE1_PHASE2
-
Jul 2022 — Sep 2022 [monthly]
Recruiting PHASE1_PHASE2
-
Jun 2022 — Jul 2022 [monthly]
Recruiting PHASE1_PHASE2
Status: Not Yet Recruiting → Recruiting
-
May 2022 — Jun 2022 [monthly]
Not Yet Recruiting PHASE1_PHASE2
-
Apr 2022 — May 2022 [monthly]
Not Yet Recruiting PHASE1_PHASE2
-
Feb 2022 — Apr 2022 [monthly]
Not Yet Recruiting PHASE1_PHASE2
-
Jan 2022 — Feb 2022 [monthly]
Not Yet Recruiting PHASE1_PHASE2
First recorded
Eligibility Summary
No eligibility information available.
Contact Information
- Novartis Pharmaceuticals
For direct contact, visit the study record on ClinicalTrials.gov .