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BET Inhibitor
Venetoclax + Bomedemstat for Acute Myeloid Leukemia (VenBom Trial)
Phase 1
Recruiting
Research Sponsored by Terrence J Bradley, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 72 weeks
Awards & highlights
VenBom Trial Summary
This trial tests the safety of combining two drugs to treat relapsed or refractory acute myeloid leukemia.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects are not listed here, common ones associated with cancer therapies like Venetoclax and Bomedemstat may include nausea, diarrhea, fatigue, risk of infection due to low blood cell counts, liver problems and potential bleeding issues.
VenBom Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 72 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 72 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Treatment-Emergent Toxicity
Recommended Phase 2 Dose (RP2D)
Secondary outcome measures
Overall Response Rate (ORR)
Proportion of Participants with Measurable Residual Disease
VenBom Trial Design
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bomedemstat
2017
Completed Phase 2
~170
Venetoclax
2019
Completed Phase 3
~1990
Find a Location
Who is running the clinical trial?
Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)Industry Sponsor
9 Previous Clinical Trials
426 Total Patients Enrolled
Terrence J Bradley, MDLead Sponsor
1 Previous Clinical Trials
24 Total Patients Enrolled
Imago BioSciences,Inc.Industry Sponsor
9 Previous Clinical Trials
426 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not been diagnosed or treated for another cancer within the last 2 years.I am able to care for myself and perform daily activities.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.I do not have any severe or uncontrolled infections.I cannot or will not follow the birth control requirements.I haven't taken any strong enzyme inducers in the last 14 days.I have veins suitable for blood draws.I have had major surgery recently or will have during the study.I am willing to undergo bone marrow tests and give blood samples when needed.I am eligible for standard or curative treatments.I do not have any uncontrolled bleeding disorders.I do not have any serious health or mental conditions that could affect my participation.I meet the menopause or birth control requirements.I agree to use specified methods of contraception.I have had severe diarrhea that didn't improve with treatment in the last week.My AML has not responded to at least one standard treatment.I am not using, nor will I need, any medications that are not allowed in the study.I do not have uncontrolled HIV or hepatitis B/C.I have severe liver problems or cirrhosis.I am 18 years old or older.I have difficulty making decisions due to my health condition.I have a known heart or lung condition.I have been diagnosed with acute promyelocytic leukemia.I haven't had cancer treatment or been in a trial for new drugs in the last 14 days.
Research Study Groups:
This trial has the following groups:- Group 1: Part 2: VenBom Expansion Cohort
- Group 2: Part 1: VenBom Dose Escalation/De-Escalation Cohort
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many patients are being included in this experiment?
"Indeed, the information hosted on clinicaltrials.gov confirms that this trial is in the process of enrolling patients. Initially posted on December 15th 2022, it was most recently edited on November 10th and requires 18 participants to be recruited from one medical centre."
Answered by AI
Are researchers still seeking participants for this venture?
"Affirmative. According to clinicaltrials.gov, this scientific trial is actively recruiting and has been since the 15th of December 2022. The study requires 18 participants across a single location and was last revised on November 10th 2022."
Answered by AI
What risks could patients incur by enrolling in the Part 2: VenBom Expansion Cohort?
"Taking into consideration the limited clinical data supporting both efficacy and safety, our analysts at Power assign a risk score of 1 to Part 2: VenBom Expansion Cohort."
Answered by AI
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