Venetoclax + Bomedemstat for Acute Myeloid Leukemia
(VenBom Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This clinical trial explores the safety and tolerability of a new combination of two drugs, Venetoclax and Bomedemstat (an LSD1 inhibitor), for people with acute myeloid leukemia (AML) that has not responded to other treatments. The trial tests different doses to identify the most manageable one for patients. It suits those diagnosed with AML who have not succeeded with at least one standard treatment. Participants will receive these drugs over several months to assess potential benefits, and the trial aims to determine if this treatment could become a new option for people with this type of leukemia. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new combination therapy.
Do I have to stop taking my current medications for the trial?
The trial does not clearly specify if you need to stop taking your current medications. However, you cannot take certain medications that affect liver enzymes within 14 days before starting the trial, and you should not use any investigational or anti-cancer treatments within 14 days prior to the trial, except for hydroxyurea.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that both Venetoclax and Bomedemstat have been studied for their safety in treating acute myeloid leukemia (AML). Venetoclax, a pill used in AML treatments, is generally well-tolerated. It works effectively, especially when combined with other treatments, helping patients who cannot undergo intensive chemotherapy to respond quickly and live longer.
Bomedemstat has undergone less study than Venetoclax, but researchers are investigating its safety and effectiveness when used with Venetoclax. This trial aims to determine the best dose levels for this combination to ensure safety and efficacy.
As this is an early phase trial, the main goal is to assess how well patients tolerate different doses of the combination. While Venetoclax is already known to be relatively safe, the combination with Bomedemstat is still under evaluation to confirm its safety in people. Prospective participants should know that Venetoclax is approved for use in AML, but Bomedemstat is still being evaluated for safety and effectiveness in this context.12345Why are researchers excited about this trial's treatments?
Most treatments for acute myeloid leukemia (AML) rely on chemotherapy to kill cancer cells. However, the combination of Venetoclax and Bomedemstat offers something new. Venetoclax targets a protein called BCL-2, which helps cancer cells survive, while Bomedemstat inhibits LSD1, an enzyme that plays a role in cancer cell growth and differentiation. This dual action could potentially enhance the effectiveness of treatment by attacking the cancer through different pathways, paving the way for better outcomes in patients with AML. Researchers are excited because this combination could offer a more targeted approach with potentially fewer side effects compared to traditional chemotherapy.
What evidence suggests that this trial's treatments could be effective for acute myeloid leukemia?
Research has shown that combining Venetoclax and Bomedemstat may help treat acute myeloid leukemia (AML). In lab tests, this combination effectively killed AML cells, indicating strong synergy. Participants in this trial will receive the combination of Venetoclax and Bomedemstat, known as VenBom, to evaluate its effectiveness. Venetoclax alone has been used for older AML patients, but sometimes the cancer stops responding to it. Adding Bomedemstat, which targets a specific enzyme, appears to enhance Venetoclax's effectiveness. This combination could be especially useful for those who haven't had success with other treatments.12678
Who Is on the Research Team?
Terrence J Bradley, MD
Principal Investigator
University of Miami
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation/De-Escalation
Participants receive Venetoclax and Bomedemstat in a dose escalation/de-escalation design to determine the maximum tolerated dose
Expansion Cohort
Participants receive VenBom therapy at the most appropriate dose determined in Part 1
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Bomedemstat
- Venetoclax
Trial Overview
The 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.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Terrence J Bradley, MD
Lead Sponsor
Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)
Industry Sponsor
Imago BioSciences,Inc.
Industry Sponsor
Citations
Venetoclax and Bomedemstat in Patients with Relapsed ...
This study aims to learn about the safety, tolerability, and different dose levels' safety profiles of Venetoclax and Bomedemstat (VenBom) combination therapy ...
2.
ashpublications.org
ashpublications.org/blood/article/146/Supplement%201/3293/550587/LSD1-inhibition-enhances-venetoclax-efficacy-inLSD1 inhibition enhances venetoclax efficacy in Acute ...
Venetoclax alone showed variable IC50 values (6.37 nM–26.3 µM) among primary AML samples, with greater sensitivity in IDH2, WT1, FLT3, and NPM1 ...
LSD1 inhibition enhances venetoclax efficacy in Acute ...
Venetoclax, a BCL2 inhibitor, improves response in older AML patients by targeting leukemic stem cell (LSC) metabolism, but resistance limits ...
Venetoclax: A New Partner in the Novel Treatment Era ...
Patients receiving azacitidine showed a median OS of 12.1 months and an overall response rate (ORR) of 27.8%, compared to an OS of 6.5 months ...
LSD1 Inhibition Synergizes with Venetoclax in Acute ...
1). Conclusion: The combination of bomedemstat and venetoclax had synergistic cytocidal effects on AML cell line and primary AML cells in vitro.
Refractory Acute Myeloid Leukemia (AML) ...
Venetoclax and Bomedemstat in Patients with Relapsed/Refractory Acute Myeloid Leukemia. Bomedemstat · IMG-7289 · Venetoclax. treatment, 1, suspended.
VIALE-A OS long-term follow-up data and RWE
See VIALE-A OS long-term follow-up data and real-word evidence from the VIALE-A clinical trial. See full safety and Prescribing Info for more details.
Venetoclax resistance in acute myeloid leukaemia ...
Venetoclax, an oral BCL-2 inhibitor, has been widely incorporated in the treatment of acute myeloid leukaemia.
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