Venetoclax in Combination With Cladribine and Cytarabine Alternating With Azacitidine Plus Venetoclax for the Treatment of Newly Diagnosed Monocytic AML and Active Signaling Mutated AML

ClinicalTrials.gov ID: NCT06504459

Public ClinicalTrials.gov record NCT06504459. 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.

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Official title

A Phase II Study of Venetoclax (ABT-199) in Combination With Cladribine and Low-Dose Cytarabine Alternating With Azacitidine Plus Venetoclax in Newly Diagnosed Monocytic AML and Active-Signaling Mutated AML

Brief summary

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

This phase II trial tests how well venetoclax with cladribine and cytarabine alternating with azacitidine and venetoclax works in treating patients with newly diagnosed monocytic acute myeloid leukemia (AML) and active signaling mutated AML. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking BCL-2, a protein needed for cancer cell survival. Chemotherapy drugs, such as cladribine, cytarabine and azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving venetoclax with cladribine and cytarabine alternating with azacitidine and venetoclax may kill more cancer cells in patients with newly diagnosed monocytic AML and active signaling mutated AML.

Study identification

NCT ID: NCT06504459
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 2
Lead sponsor: OHSU Knight Cancer Institute; Other
Enrollment: 40 participants

Conditions and interventions

Conditions

Interventions

Drug · Procedure · Other

Eligibility (public fields only)

Age range: 18 Years and older
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: Jan 2, 2025
Primary completion: Oct 10, 2027
Completion: Apr 30, 2028
Last update posted: Apr 12, 2026

2025 – 2028

United States locations

U.S. sites: 2
U.S. states: 2
U.S. cities: 2

Facility	City	State	ZIP	Site status
University of Miami Miller School of Medicine-Sylvester Cancer Center	Miami	Florida	33136	Recruiting
OHSU Knight Cancer Institute	Portland	Oregon	97239	Recruiting

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

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT06504459, 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 Apr 12, 2026 · Synced Sep 7, 2026

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The complete protocol, eligibility criteria, and contact information for NCT06504459 live on ClinicalTrials.gov.

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