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Protein Synthesis Inhibitor

Venetoclax + Omacetaxine for Acute Myeloid Leukemia (AML)(VEN-OM Trial)

University of Illinois Cancer Center, Chicago, IL

Omacetaxine +1 morePhase 1RecruitingLed by John Quigley, MDResearch 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

Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to registration. NOTE: Females are considered of child bearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they have not experienced menstruation for at least 12 consecutive months

Have relapsed/refractory AML (primary or secondary) and have progressed on ≥ 1 line of therapy, at least one of which must have included a VEN-containing regimen.

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up12 months

Awards & highlights

No Placebo-Only Group

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.

Eligible Conditions

Relapsed or Refractory Hematologic Malignancies

VEN-OM Trial Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

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You must have completed any previous cancer treatments at least 21 days before joining the study, and must have recovered from any temporary side effects of the treatment.

VEN-OM Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

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 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

VEN-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

Omacetaxine

2011

Completed Phase 2

~100

Venetoclax

2019

Completed Phase 3

~2100

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Illinois at ChicagoLead Sponsor

578 Previous Clinical Trials

1,554,972 Total Patients Enrolled

John Quigley, MDPrincipal InvestigatorUniversity of Illinois at Chicago

2 Previous Clinical Trials

46 Total Patients Enrolled

Media Library

Omacetaxine (Protein Synthesis Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04926285 — Phase 1

Hematologic Malignancies Research Study Groups: Cohort 3, Cohort 4, Cohort 1, Cohort 2

Hematologic Malignancies Clinical Trial 2023: Omacetaxine Highlights & Side Effects. Trial Name: NCT04926285 — Phase 1

Omacetaxine (Protein Synthesis Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04926285 — Phase 1

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 medical condition is Omacetaxine typically used to treat?

"The FDA has approved the utilization of Omacetaxine to manage refractory, chronic phase chronic myeloid leukemia, small lymphocytic lymphoma (SLL), and Chronic Lymphocytic Leukaemia (CLL)."

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