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Menin Inhibitor

Venetoclax + Revumenib for Acute Myeloid Leukemia

Q: What are the potential risks associated with combining Venetoclax and Revumenib for individuals undergoing treatment?

<p>According to our evaluation at Power, the safety rating for Venetoclax + Revumenib is 2 on a scale of 1 to 3. This assessment is based on it being a Phase 2 trial where some safety data exists but no efficacy data has been reported yet.</p>

Phase 2

Waitlist Available

Led By Ghayas Issa, 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

ECOG performance status of ≤ 2

Bone marrow assessment showing no leukemia by morphology (blasts <5%) in first remission following high intensity chemotherapy or at least 2 cycles of low intensity therapy (e.g. hypomethylating agent or low-dose cytarabine-based), or in second remission following any therapy, with MRD ≥ 0.1% identified by multiparameter flow cytometry using central lab testing

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion; an average of 1 year.

Awards & highlights

Study Summary

"This trial aims to see if using a combination of venetoclax and revumenib can help in managing MRD-positive AML."

Who is the study for?

This trial is for individuals aged 12 or older, weighing at least 45Kg, with MRD-positive AML in remission but still showing signs of cancer cells. They must have proper kidney and liver function, no severe heart issues, and not be pregnant or breastfeeding. Participants should agree to use contraception and not have any active infections or other health conditions that could interfere with the study.Check my eligibility

What is being tested?

The trial is testing a combination of two drugs, Venetoclax and Revumenib, to see if they can control Acute Myeloid Leukemia (AML) when there's minimal residual disease (MRD). It involves patients who've had some treatment but still have traces of leukemia despite appearing in remission.See study design

What are the potential side effects?

Potential side effects may include digestive problems, risk of infection due to weakened immune system from the medications, possible liver dysfunction indicated by changes in blood tests results, fatigue from anemia caused by bone marrow suppression among others.

Eligibility Criteria

Inclusion Criteria

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

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I can take care of myself but might not be able to do heavy physical work.

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My leukemia is in remission with less than 5% blasts after intense treatment, and minimal residual disease is detected.

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I am at least 12 years old and weigh 45 kg or more.

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My leukemia has a specific genetic change.

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I do not have active cancer outside of my bone marrow.

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My kidney function is good, with a filtration rate of 60 mL/min or higher.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion; an average of 1 year.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion; an average of 1 year.

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Safety and adverse events (AEs)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Venetoclax + RevumenibExperimental Treatment2 Interventions

Participants may receive the combination of venetoclax and revumenib for up to 1 year, and then 1 more year of venetoclax alone. You will no longer be able to take the study drug(s) if the disease gets worse or if intolerable side effects occur. Participants will take venetoclax by mouth on 1 time a day at about the same time each day, on Days 1-14 of each cycle. Take each dose with about 1 cup of water within 30 minutes after a meal, preferably breakfast.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Venetoclax

2019

Completed Phase 3

~1990

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Break Through CancerUNKNOWN

M.D. Anderson Cancer CenterLead Sponsor

2,966 Previous Clinical Trials

1,804,773 Total Patients Enrolled

Syndax PharmaceuticalsIndustry Sponsor

48 Previous Clinical Trials

2,766 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the potential risks associated with combining Venetoclax and Revumenib for individuals undergoing treatment?

"According to our evaluation at Power, the safety rating for Venetoclax + Revumenib is 2 on a scale of 1 to 3. This assessment is based on it being a Phase 2 trial where some safety data exists but no efficacy data has been reported yet."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Multi-Site Break Through Cancer Trial: Phase II Study Investigating Dual Inhibition of BCL2 and Menin in AML MRD Using the Combination of Venetoclax and Revumenib

2024. "A Multi-Site Break Through Cancer Trial: Phase II Study Investigating Dual Inhibition of BCL2 and Menin in AML MRD Using the Combination of Venetoclax and Revumenib". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06284486.