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Protein Synthesis Inhibitor
Omacetaxine + Venetoclax for Acute Myeloid Leukemia
Phase 1 & 2
Recruiting
Led By Courtney DiNardo, MD
Research Sponsored by M.D. Anderson Cancer Center
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 3 years
Awards & highlights
Study Summary
This trial is testing the best dose of omacetaxine and venetoclax to see how well it works in treating patients with acute myeloid leukemia or myelodysplastic syndrome that has come back or does not respond to treatment and have a genetic change RUNX1.
Who is the study for?
Adults over 18 with relapsed or refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS), who have not responded to certain treatments and have a RUNX1 gene mutation. Participants must be in relatively good health otherwise, with specific organ function criteria met. Women of childbearing potential must use effective contraception.Check my eligibility
What is being tested?
The trial is testing the combination of two drugs, omacetaxine and venetoclax, for their effectiveness against AML/MDS that's resistant to treatment. Omacetaxine aims to stop cancer cells from growing by killing them or preventing division, while venetoclax targets a protein essential for cancer cell survival.See study design
What are the potential side effects?
Potential side effects may include reactions related to chemotherapy such as nausea, fatigue, risk of infection due to low blood counts, liver issues indicated by elevated bilirubin levels, and other non-specified drug-related toxicities.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events
Overall response rate
Secondary outcome measures
Duration of response
Event-free survival (EFS)
Overall survival (OS)
Other outcome measures
Biomarker analysis
Side effects data
From 2022 Phase 3 trial • 389 Patients • NCT0200547133%
Neutropenia
11%
Neutrophil count decreased
11%
Blood creatinine increased
11%
Hypokalaemia
11%
Dermatitis
11%
Pneumonia pseudomonal
11%
Rhinovirus infection
11%
White blood cell count decreased
11%
Pneumonia
11%
Abdominal pain
11%
Anaemia
11%
Sepsis
11%
Gastroenteritis
11%
SARS-CoV-2 test positive
11%
Electrocardiogram QT prolonged
11%
Febrile neutropenia
11%
COVID-19
11%
Supraventricular tachycardia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bendamustine + Rituximab Crossover Substudy
Venetoclax + Rituximab Re-Treatment Substudy
Venetoclax + Rituximab Main Study
Bendamustine + Rituximab Main Study
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (omacetaxine, venetoclax)Experimental Treatment2 Interventions
Patients receive omacetaxine SC BID on days 2-3 or 2-4, and venetoclax PO on days 1-7, 1-10 or 1-14. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Omacetaxine Mepesuccinate
1998
Completed Phase 2
~90
Venetoclax
2019
Completed Phase 3
~1990
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,972 Previous Clinical Trials
1,787,237 Total Patients Enrolled
Courtney DiNardo, MDPrincipal InvestigatorM.D. Anderson Cancer Center
10 Previous Clinical Trials
510 Total Patients Enrolled
Courtney DiNardoPrincipal InvestigatorM.D. Anderson Cancer Center
8 Previous Clinical Trials
625 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My leukemia is of a specific type (APL) with a known genetic marker.I do not have any severe health or mental conditions that are not under control.I have had a stem cell transplant but do not currently have active graft-versus-host disease.I do not have severe stomach or metabolic issues affecting medication absorption.I have an active hepatitis B, hepatitis C, or HIV infection.My white blood cell count is above 25 x 10^9/L.I am a woman who could become pregnant and agree to use birth control.I am using effective birth control methods.My condition is a type of leukemia that has returned or didn't respond to treatment.My MDS didn't improve or got worse after 4 cycles of specific treatments, or those treatments were too harsh for me.I can take care of myself but might not be able to do heavy physical work.I am 18 years old or older.My condition involves a RUNX1 gene mutation.I agree not to have unprotected sex or donate sperm for 90 days after my last dose.I haven't had cancer treatment in the last 7 days, except for specific drugs for fast-growing cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (omacetaxine, venetoclax)
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.
What medical conditions does Venetoclax typically help ameliorate?
"Venetoclax can be used to treat refractory, chronic phase chronic myeloid leukemia, small lymphocytic lymphoma, and chronic lymphocytic leukemia (cll)."
Answered by AI
How many individuals are being signed up for this research project?
"That is correct, the online listing for this clinical trial says that it is currently looking for participants. This study was first posted on December 17th 2021 and 84 people are needed from 1 site."
Answered by AI
Are people currently being signed up for this experiment?
"This study is still looking for volunteers, as seen on clinicaltrials.gov. The listing was first created on December 17th, 2021 and most recently updated January 11th, 2022."
Answered by AI
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