Venetoclax + Azacitidine + Eganelisib for Acute Myeloid Leukemia

(GAVEL Trial)

Not yet recruiting at 1 trial location

Overseen By Jacqueline Garcia, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Jacqueline Garcia, MD

Must be taking: Venetoclax, Azacitidine, Eganelisib

Must not be taking: CYP3A4 inhibitors, P-gp inhibitors

Disqualifiers: Pregnancy, Active GVHD, High WBC, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 28 days per cycle

What You Need to Know Before You Apply

What is the purpose of this trial?

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)

Who Is on the Research Team?

Jacqueline Garcia, MD

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

Inclusion Criteria

* AST(SGOT)/ALT(SGPT) ≤ 2.5 x × institutional ULN

* Creatinine clearance (CrCl) ≥ 30 L/min (Cockcroft-Gault formula)

* total serum bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) or ≤ 3 x ULN in case of Gilbert's disease

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive azacitidine, venetoclax, and eganelisib in 28-day cycles to determine the maximum tolerated dose and recommended phase 2 dose

28 days per cycle

Baseline visit, in-clinic visits, end of treatment visit

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up every 4 months for up to 1 year

1 year

Follow-up every 4 months

What Are the Treatments Tested in This Trial?

Interventions

• Azacitidine
• Eganelisib
• Venetoclax

How Is the Trial Designed?

Group I: Dose-Expansion Eganelisib Experimental Treatment 3 Interventions

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).

Group II: Dose-Escalation Eganelisib Experimental Treatment 3 Interventions

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).

Who Is Running the Clinical Trial?

Jacqueline Garcia, MD

Lead Sponsor

Trials

3

Recruited

130+

Stelexis BioSciences, Inc.

Collaborator