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Menin Inhibitor

Revumenib for Leukemia

Phase 2

Recruiting

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

Relapsed or refractory acute leukemia, of either myeloid, lymphoid or mixed lineages, with specific genetic alterations associated with upregulation of HOX

Must not have

Participant has an active uncontrolled infection

Clinically active central nervous system (CNS) leukemia

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if a drug called revumenib can help to control certain types of leukemia that are related to increased expression of HOX genes.

Who is the study for?

This trial is for individuals with leukemia that's linked to high activity of HOX genes. Specific eligibility details are not provided, but typically participants would need a confirmed diagnosis and may have to meet certain health requirements.

What is being tested?

The study is testing the effectiveness of Revumenib, a Menin inhibitor, in managing leukemia where there's an upregulation of HOX genes. It aims to determine if this drug can control the disease.

What are the potential side effects?

Potential side effects for Revumenib aren't listed here, but common ones for cancer drugs include nausea, fatigue, risk of infection, and blood count changes. The exact side effects will be monitored throughout the trial.

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 and am up and about more than half of my waking hours.

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My leukemia has returned or is not responding to treatment and has specific genetic changes.

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My kidneys work well, with a filtration rate of at least 60 mL/min.

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I agree to use birth control during and for 3 months after the study.

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I am 12 years or older and weigh at least 40kg.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I currently have an infection that isn't under control.

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My leukemia is affecting my brain or spinal cord.

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I have severe acute or chronic GVHD.

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I do not have any uncontrolled health issues that could make the study unsafe for me.

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I do not have severe stomach or metabolic issues affecting medication absorption.

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I am currently being treated for another active cancer.

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I do not have active hepatitis B, hepatitis C, or HIV.

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I am not pregnant or breastfeeding.

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I haven't had a heart attack, severe heart issues, or a stroke in the last 6 months.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety and adverse events (AEs)

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Arm 1Experimental Treatment1 Intervention

Participants found to be eligible to take part in this study, will take revumenib 2 times a day (each dose about 12 hours apart), every day of each 28-day study cycle.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Revumenib

2022

Completed Phase 1

~30

0 / 14Eligibility criteria met