Venetoclax + Bomedemstat for Acute Myeloid Leukemia
(VenBom Trial)

Recruiting in Palo Alto (17 mi)

Overseen byTerrence J Bradley, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Terrence J Bradley, MD

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This study aims to learn about the safety, tolerability, and different dose levels' safety profiles of Venetoclax and Bomedemstat (VenBom) combination therapy in participants with relapsed or refractory acute myeloid leukemia.

Research Team

Terrence J Bradley, MD

Principal Investigator

University of Miami

Eligibility Criteria

Adults over 18 with relapsed/refractory Acute Myeloid Leukemia (AML) who have failed at least one standard therapy can join. They must be able to undergo blood sampling, have a life expectancy allowing for 3 months of treatment, and agree to contraception or abstinence. Exclusions include candidates for curative treatments, certain viral infections, other recent malignancies, severe liver impairment, uncontrolled bleeding disorders or heart disease.

Inclusion Criteria

I am able to care for myself and perform daily activities.

I have veins suitable for blood draws.

Voluntary written consent for study-related procedures

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Exclusion Criteria

I have not been diagnosed or treated for another cancer within the last 2 years.

I have symptoms from my cancer spreading to my brain or spinal cord.

I do not have a life-threatening illness unrelated to my cancer.

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Treatment Details

Interventions

Bomedemstat (BET Inhibitor)
Venetoclax (BCL-2 Inhibitor)

Trial OverviewThe trial is testing the combination of Venetoclax and Bomedemstat (VenBom) on AML patients who've had previous treatment failure. It aims to determine the safety and tolerability of different dose levels of this combo therapy.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Part 2: VenBom Expansion CohortExperimental Treatment2 Interventions

Participants in this group will receive VenBom therapy at the most appropriate dose determined in Part 1. Participants will continue to receive treatment as long as receiving clinical benefit or until disease progression.

Group II: Part 1: VenBom Dose Escalation/De-Escalation CohortExperimental Treatment2 Interventions

Participants in this group will receive Venetoclax and Bomedemstat (VenBom) in a dose escalation/de-escalation design to determine the maximum tolerated dose (MTD). Participants will receive VenBom for 21 days on (Days 1-21) and seven days off (Days 22-28) during a 28-day cycle for three months. Doses will be administered as follows: * Dose Level -2: 0.375 mg/kg daily (d) Bomedemstat and 200 mg/d Venetoclax; * Dose Level -1: 0.75 mg/kg/d Bomedemstat and 200 mg/d Venetoclax; * Dose Level 1 (Starting): 1.5 mg/kg/d Bomedemstat and 200 mg/d Venetoclax; * Dose Level 2: 3 mg/kg/d Bomedemstat and 200 mg/d Venetoclax; * Dose Level 3: 3 mg/kg/d Bomedemstat and 400 mg/d Venetoclax. Participants will receive three cycles of VenBom, but may continue to receive treatment as long as receiving clinical benefit or until disease progression. Participants starting at dose levels -2, -1, or 1 receive 100 mg Venetoclax on Cycle 1 Day 1.