MedTrace Logo

Assessing PI3K Gamma Inhibition With Azacitidine, Venetoclax and Eganelisib in Patients With Acute Myeloid Leukemia

NCT07439211 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-03-03

No results posted yet for this study

Summary

This study is to evaluate the safety and preliminary efficacy of adding the PI3K-gamma inhibitor, eganelisib, to a standard of care treatment option with combination venetoclax and azacitidine in participants with acute myeloid leukemia (AML).

The names of the study drugs involved in this research study are:

* Venetoclax (a type of BCL-2 inhibitor)
* Azacitidine (a type of Demethylating Agent)
* Eganelisib (a type of PI3K-gamma inhibitor)

Conditions

Interventions

DRUG

Eganelisib

PI3K-gamma inhibitor, capsule taken orally per protocol.

DRUG

Azacitidine

Demethylating Agent, single use vial, via subcutaneous (under the skin) injection or intravenous (into the vein) infusion per standard of care.

DRUG

Venetoclax

BCL-2 inhibitor, tablet taken orally per standard of care.

Sponsors & Collaborators

  • Stelexis BioSciences, Inc.

    collaborator UNKNOWN

  • Jacqueline Garcia, MD

    lead OTHER

Principal Investigators

  • Jacqueline Garcia, MD · Dana-Farber Cancer Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2028-02-01
Completion
2029-02-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07439211 on ClinicalTrials.gov