Safety of Targeting PI3Kgamma Signaling With Azacitidine, Venetoclax and Eganelisib in Acute Myeloid Leukemia: A Phase 1 Study (GAVEL)
Jacqueline Garcia, MD
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)
Description
This phase 1 clinical trial 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 dose-escalation portion of the trial will aim to establish the maximum tolerated dose of the drug, eganelisib, for the recommended phase 2 dose. The dose-expansion portion of the trial will aim to confirm the recommended phase 2 dose of the drug, eganelisib. The U.S. Food and Drug Administration (FDA) has not approved eganelisib as…
Eligibility
- Age range
- 18–90 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Subjects must have histologically confirmed AML that meets one of these categories of disease: * Group A: Relapsed or Refractory: Subjects with relapsed or refractory AML or relapsed/refractory AML, who are not recommended for any approved targeted therapy must meet any one of the following criteria: (1) morphologic relapse (at least 5% blasts), or (2) refractory to intensive chemotherapy (at least one cycle of cytarabine and anthracycline-based intensive regimen) or at least 2 cycles of prior HMA/venetoclax-based therapy (without CR/CRh/CRi). No limit to prior lines…
Interventions
- DrugEganelisib
PI3K-gamma inhibitor, capsule taken orally per protocol.
- DrugAzacitidine
Demethylating Agent, single use vial, via subcutaneous (under the skin) injection or intravenous (into the vein) infusion per standard of care.
- DrugVenetoclax
BCL-2 inhibitor, tablet taken orally per standard of care.
Locations (2)
- Brigham and Women's HospitalBoston, Massachusetts
- Dana Farber Cancer InstituteBoston, Massachusetts