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Menin Inhibitor

Revumenib for Acute Leukemia

Phase 1

Waitlist Available

Led By Brian Ball

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age criteria: Participants must be >= 2 years old

Participants must have a date for transplant within the next 4 weeks or have received a transplant within the last 4 months

Must not have

Patients scheduled to undergo HCT or those who have undergone HCT with a prior diagnosis of acute promyelocytic leukemia are excluded

Participants unable to take a strong CYP3A4 inhibitor or requiring medications known to prolong QT interval are excluded

Timeline

Screening 3 weeks

Treatment Varies

Follow Up start of protocol therapy to first observation of developing grade 3-4 acute gvhd, chronic gvhd requiring systemic therapy, relapse/progression, or death, assessed up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

"This trial is testing a new medication called revumenib for treating acute leukemia in patients who have received a stem cell transplant. Revumenib works by targeting a specific protein involved in the development of leukemia

Who is the study for?

This trial is for patients with acute leukemia who have undergone an allogeneic stem cell transplant. It's designed to test the safety and effectiveness of a new medication called revumenib, which targets proteins that help leukemia cells grow.

What is being tested?

The study involves testing revumenib, a menin inhibitor drug, to determine its best dose and how well it can treat acute leukemia post-transplant. The trial includes various assessments like bone marrow tests, heart scans (echocardiography), and health questionnaires.

What are the potential side effects?

Potential side effects of revumenib may include reactions at the site of administration, changes in blood counts leading to increased infection risk or bleeding problems, fatigue, digestive issues such as nausea or diarrhea, and possible liver function changes.

Eligibility Criteria

Inclusion Criteria

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

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I am at least 2 years old.

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I am scheduled for a transplant soon or had one in the last 4 months.

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I have been treated with menin inhibitors before my stem cell transplant.

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I meet the health and eligibility requirements for a stem cell transplant.

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I have given my informed consent for a bone marrow transplant.

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I have been diagnosed with acute leukemia according to WHO standards.

Exclusion Criteria

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

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I have not had a stem cell transplant for acute promyelocytic leukemia.

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I can take strong CYP3A4 inhibitors and do not need medications that prolong the QT interval.

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

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I do not have any medical conditions that would prevent me from taking Revumenib.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ start of protocol therapy to first observation of developing grade 3-4 acute gvhd, chronic gvhd requiring systemic therapy, relapse/progression, or death, assessed up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~start of protocol therapy to first observation of developing grade 3-4 acute gvhd, chronic gvhd requiring systemic therapy, relapse/progression, or death, assessed up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and start of protocol therapy to first observation of developing grade 3-4 acute gvhd, chronic gvhd requiring systemic therapy, relapse/progression, or death, assessed up to 2 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Incidence of adverse events

Secondary study objectives

Ability to complete at least 7 cycles of revumenib therapy

Cumulative incidence of chronic GVHD

Cumulative incidence of non-relapse mortality (NRM)

+6 more

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: Treatment (revumenib)Experimental Treatment8 Interventions

Starting 50-150 days after alloHCT, patients receive revumenib PO QD or every 12 hours on days 1-28 of each cycle. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo bone marrow biopsy during screening and may undergo ECHO during screening and as clinically indicated. Patients also undergo bone marrow aspiration and collection of blood samples throughout the trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bone Marrow Aspiration

2011

Completed Phase 2

~1740

Echocardiography

2013

Completed Phase 4

~11580