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Epigenetic Modifiers

Radiolabeled SNDX-5613 for Acute Leukemia

Phase 1

Recruiting

Research Sponsored by Syndax Pharmaceuticals

Eligibility Criteria Checklist

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

Must have

Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2

Relapsed or refractory acute leukemia, including participants who are MRD-positive by multiparametric flow cytometry or next-generation sequencing, and including participants with isolated extramedullary disease

Must not have

Any concurrent systemic treatment to prevent GVHD

Active diagnosis of acute promyelocytic leukemia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will study how a new cancer drug is absorbed, metabolized, and excreted in male patients with AML.

Who is the study for?

Adults over 18 with acute leukemia, either relapsed or refractory, including those who are MRD-positive. Participants must have an ECOG score of 0-2 and adequate liver/cardiac function. Men must agree to use barrier contraception for a specified period post-treatment. Exclusions include high WBC count at enrollment, active viral infections like HIV or hepatitis B/C, recent participation in other drug trials, and certain medical conditions.

What is being tested?

The trial is testing SNDX-5613's absorption, metabolism, and excretion in adults with acute leukemia. It's an open-label study which means everyone knows they're getting the test drug ([14C])-SNDX-5613 without any comparison to a placebo.

What are the potential side effects?

While specific side effects of SNDX-5613 aren't listed here, common side effects for similar leukemia treatments can include nausea, fatigue, risk of infection due to low blood cell counts, bleeding or bruising easily from low platelet counts.

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 acute leukemia has returned or didn't respond to treatment, and tests show minimal residual disease.

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I have received the standard treatment for my condition.

Exclusion Criteria

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

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I am currently receiving treatment to prevent graft-versus-host disease.

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I have been diagnosed with acute promyelocytic leukemia.

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I am not taking any strong medications that affect liver enzymes.

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I have Hepatitis B or C.

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I have only used steroids or hydroxyurea for my leukemia, not other treatments.

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I have heart, stomach issues, or problems after a transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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: RevumenibExperimental Treatment1 Intervention

Participants will be administered a single dose of revumenib (containing \~100 microcuries \[14C\]-revumenib) in the AME part of the study. Each dose administered after the first dose in the AME part of the study will be nonradiolabeled revumenib. revumenib may continue to be administered following completion of the AME part of the study. Doses will be administered in continuous 28-day cycles until either PD or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Revumenib

2022

Completed Phase 1

~30

0 / 9Eligibility criteria met