Venetoclax and Bomedemstat in Patients With Relapsed/Refractory Acute Myeloid Leukemia

Part of paid clinical trials in Miami, Florida.

Sponsor
Terrence J Bradley, MD
Study ID
NCT05597306
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bomedemstat — DRUG
    Bomedemstat will be administered orally once daily via capsule.
  • Venetoclax — DRUG
    Venetoclax will be administered orally once daily via tablet.

Study Details

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.

Key Dates

Start date
Nov 19, 2022
Status verified
Jan 2026
Primary completion
Nov 19, 2026
Completion
Nov 19, 2026

Study Design

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

Arms

  • Experimental: Part 1: VenBom Dose Escalation/De-Escalation Cohort
    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.
  • Experimental: Part 2: VenBom Expansion Cohort
    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.

Primary Outcome Measure

Incidence of Treatment-Emergent Toxicity [ Time Frame: Up to 72 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33136
Alessia Zoso, PhD
[email protected]
305-243-2373
Terrence Bradley, MD
[email protected]
305-243-1000
Terrence Bradley, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Miami, FL

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
University of Miami· Miami, FL

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