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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Jacqueline Garcia, MD
Study ID
NCT07439211
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Eganelisib — DRUG
    PI3K-gamma inhibitor, capsule taken orally per protocol.
  • Azacitidine — DRUG
    Demethylating Agent, single use vial, via subcutaneous (under the skin) injection or intravenous (into the vein) infusion per standard of care.
  • Venetoclax — DRUG
    BCL-2 inhibitor, tablet taken orally per standard of care.

Study Details

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)

Key Dates

First listed
Feb 27, 2026
Start date
Apr 13, 2026
Status verified
Feb 2026
Primary completion
Feb 1, 2028
Completion
Feb 1, 2029

Study Design

Enrollment
48 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose-Escalation Eganelisib
    Dose-Escalation with triplet azacitidine D1-7, venetoclax D1-28 and eganelisib D1-28 (dose-escalated) * Baseline visit * Treatment in 28 day cycles * End of treatment visit * Follow up every 4 months for up to 1 year after end of treatment (for survival).
  • Experimental: Dose-Expansion Eganelisib
    Dose-Escalation with triplet azacitidine D1-7, venetoclax D1-28 and eganelisib D1-28 (dose-expansion at MTD/RP2D) * Baseline visit * Treatment in 28 day cycles * End of treatment visit * Follow up every 4 months for up to 1 year after end of treatment (for survival).

Primary Outcome Measure

Eganelisib Recommended Phase 2 Dose (RP2D) [ Time Frame: 1 cycle=28 days ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115
Jacqueline S Garcia, MD
[email protected]
617-632-6577
Jacqueline Garcia, MD (PRINCIPAL_INVESTIGATOR)
Dana Farber Cancer InstituteBostonMassachusetts02115
Jacqueline S Garcia, MD
[email protected]
617-632-6577
Jacqueline Garcia, MD (PRINCIPAL_INVESTIGATOR)

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