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Completed Phase 1 Interventional

A Study of Siremadlin in Combination With Venetoclax Plus Azacitidine in Adult Participants With Acute Myeloid Leukemia (AML) Who Are Ineligible for Chemotherapy.

ClinicalTrials.gov ID: NCT05155709

Public ClinicalTrials.gov record NCT05155709. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 10, 2026, 11:31 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

A study of siremadlin in combination with venetoclax plus azacitidine in adult participants with AML who are ineligible for chemotherapy. The primary purpose of this study was to assess whether siremadlin in combination with venetoclax plus azacitidine can enhance the clinical response in unfit AML participants without unacceptable levels of treatment-emergent toxicities.

Study identification

NCT ID
NCT05155709
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Novartis Pharmaceuticals
Industry
Enrollment
14 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 99 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 16, 2022
Primary completion
Apr 16, 2024
Completion
Apr 16, 2024
Last update posted
May 6, 2026

2022 – 2024

United States locations

U.S. sites
2
U.S. states
2
U.S. cities
2
Facility City State ZIP Site status
Oregon Health Sciences University Portland Oregon 97239
Texas Oncology Sammons Cancer Center Dallas Texas 78246

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 8 non-U.S. sites.

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About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05155709, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 6, 2026 · Synced Sep 10, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05155709 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →