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Protein Synthesis Inhibitor
Venetoclax + Omacetaxine for Blood Cancer (VEN-OM Trial)
Phase 1
Recruiting
Led By John Quigley, MD
Research Sponsored by University of Illinois at Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Demonstrate adequate organ function: Renal Creatinine/Calculated creatinine clearance (CrCl) CrCl ≥ 50 mL/min using the Cockcroft-Gault formula, Hepatic Bilirubin ≤ 1.5 × upper limit of normal (ULN), Aspartate aminotransferase (AST) ≤ 3 × ULN, Alanine aminotransferase (ALT) ≤ 3 × ULN
Age 18-75 years of age at time of consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
VEN-OM Trial Summary
This trial will test a new combination of drugs to find the maximum tolerated dose for people with relapsed or refractory blood cancers who have failed other treatments.
Who is the study for?
Adults aged 18-75 with Acute Myeloid Leukemia (AML) that has returned or didn't respond to treatment, including a regimen with Venetoclax. Participants must have finished previous cancer treatments at least 21 days before and recovered from their effects, be able to perform daily activities with minimal assistance (ECOG score 0-2), not be pregnant or breastfeeding, agree to use contraception, and have adequate organ function.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of combining two drugs: Venetoclax and Omacetaxine in escalating doses for AML patients who haven't responded well to previous treatments. It's an open-label study where everyone gets the same treatment, starting with induction then consolidation phases if needed.See study design
What are the potential side effects?
Potential side effects may include diarrhea, nausea, low blood cell counts leading to increased infection risk or bleeding problems, fatigue, liver issues indicated by abnormal blood tests results. Specific side effects related to each drug will also be monitored closely.
VEN-OM Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney and liver functions are within the required range.
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I am between 18 and 75 years old.
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My AML has returned or didn't respond to treatment, including one with VEN.
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I am able to care for myself and perform daily activities.
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I can follow the study's procedures for its duration.
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I finished my last cancer treatment over 3 weeks ago and have recovered from its side effects.
VEN-OM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum tolerated dose (MTD) of Omacetaxine in combination with Venetoclax
Secondary outcome measures
Efficacy of Omacetaxine in combination with Venetoclax
Evaluate AEs
Event Free Survival (EFS)
+1 moreVEN-OM Trial Design
4Treatment groups
Experimental Treatment
Group I: Cohort 4Experimental Treatment2 Interventions
Omacetaxine 2.5 mg/m2 SQ injection q12h days 1-7 with Venetoclax 400 mg orally daily on days 4-28 Cycles are 28 days
Group II: Cohort 3Experimental Treatment2 Interventions
Omacetaxine 2.0 mg/m2 SQ injection q12h days 1-7 with Venetoclax 400 mg orally daily on days 4-28 Cycles are 28 days
Group III: Cohort 2Experimental Treatment2 Interventions
Omacetaxine 1.25 mg/m2 SQ injection q12h days 1-7 with Venetoclax 400 mg orally daily on days 4-28 Cycles are 28 days
Group IV: Cohort 1Experimental Treatment2 Interventions
Omacetaxine 0.625 mg/m2 SQ injection q12h days 1-7 with Venetoclax 400 mg orally daily on days 4-28 Cycles are 28 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venetoclax
2019
Completed Phase 3
~1990
Omacetaxine
2011
Completed Phase 2
~100
Find a Location
Who is running the clinical trial?
University of Illinois at ChicagoLead Sponsor
609 Previous Clinical Trials
1,559,279 Total Patients Enrolled
John Quigley, MDPrincipal InvestigatorUniversity of Illinois at Chicago
2 Previous Clinical Trials
40 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I finished my last cancer treatment over 3 weeks ago and have recovered from its side effects.I do not have any severe or uncontrolled infections.My kidney and liver functions are within the required range.I do not have any severe health or mental conditions that could make this study risky for me.I cannot take medicine by mouth due to a digestive condition.I have previously used Omacetaxine.I had a stem cell transplant less than 2 months ago.I have a bleeding or clotting disorder that is moderate to severe.I am between 18 and 75 years old.My leukemia has spread to my brain or spinal cord.My white blood cell count is above 25,000, even if I'm taking hydroxyurea.I have not had any other cancers in the last year.My AML has returned or didn't respond to treatment, including one with VEN.I am able to care for myself and perform daily activities.I can follow the study's procedures for its duration.I am of childbearing age and have a recent negative pregnancy test.I have hepatitis B or C but meet certain exceptions.I have a history of heart failure treated, with poor heart pump function.I haven't taken strong or moderate CYP3A affecting drugs in the last week.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 3
- Group 2: Cohort 4
- Group 3: Cohort 1
- Group 4: Cohort 2
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.
Is enrollment for this clinical experiment currently available?
"The clinicaltrial.gov website confirms that this investigation is currently looking for participants, with the initial post on June 21st 2022 and the most recent update occurring September 27th of the same year."
Answered by AI
Are there any requirements to participate in this clinical research?
"Eligible participants for this study must have hematologic neoplasms and be aged between 18 - 75. The current recruitment goal is roughly 30 patients."
Answered by AI
What potential adverse effects could result from the use of Omacetaxine?
"Our team has determined that the safety of omacetaxine is uncertain, and thus it receives a score of 1. This assessment was based on the fact that this clinical trial is in phase one, indicating minimal to no data supporting efficacy or safety."
Answered by AI
How many participants are being treated as part of this clinical experiment?
"Affirmative, the clinicaltrials.gov listing for this trial indicates that it is currently in search of participants. Originally posted on June 21st 2022 and last updated on September 27th 2022, the research requires 30 recruits from a single medical centre."
Answered by AI
Are geriatric patients being welcomed as part of this medical experiment?
"The age range of participants eligible for this trial are those over 18 years and under 75 years old."
Answered by AI
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