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Study of Radiolabeled Revumenib in Adults With Acute Leukemia | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Study of Radiolabeled Revumenib in Adults With Acute Leukemia

A Phase 1, Open-label Study to Assess the Mass Balance, Pharmacokinetics, and Metabolism of Orally Administered [14C]-SNDX-5613 in Patients With Relapsed/Refractory Acute Leukemia

NCT05406817•Syndax Pharmaceuticals

View on ClinicalTrials.gov

Summary

This is an open-label study to evaluate the absorption, metabolism, and excretion (AME) of carbon-14 (\[14C\])-revumenib in participants with acute leukemia.

Detailed Description

Participants will be enrolled in this study primarily to complete the 11-day AME portion of the study; participants who are receiving benefit from revumenib may remain on study until progressive disease (PD) or unacceptable toxicity.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Males and females (of non-childbearing potential) aged ≥18 years
•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.
•Previously received standard of care therapy
•Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
•Adequate liver and cardiac function
•Fertile males agree to use barrier contraception from the time of enrollment through 120 days after the last study drug dose

Exclusion Criteria

•Active diagnosis of acute promyelocytic leukemia
•White blood cell (WBC) count \>25,000/microliters at time of enrollment.
•Detectable human immunodeficiency virus viral load within the previous 6 months
•Hepatitis B or Hepatitis C
•Cardiac, gastrointestinal, or graft-versus-host disease (GVHD)
•History of or any concurrent condition, therapy, laboratory abnormality, or allergy to excipients that might confound the results of the study, interfere with the participant's ability to participate for the full duration of the study, or not be in the best interest of the participant to participate
•Must not be receiving any moderate or strong cytochrome P450 3A4 (CYP3A4) inhibitor/inducers
•Any commercially available or investigational antileukemic therapy other than revumenib except for short-term administration of corticosteroids and/or hydroxyurea for cytoreduction
•Participation in another therapeutic interventional clinical study in which an investigational agent was administered within 30 days before starting revumenib
•Any concurrent systemic treatment to prevent GVHD

Locations (1)

MD Anderson Cancer Center

Houston, Texas, United States

Key Dates

Start Date

August 5, 2022

Primary Completion Date

November 18, 2024

Completion Date

November 18, 2024

Last Updated

January 10, 2025

Enrollment

ACTUAL participants

Conditions

Acute Leukemia

Interventions

Revumenib

DRUG

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RECRUITINGPHASE2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 10, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Study of Radiolabeled Revumenib in Adults With Acute Leukemia

Inclusion Criteria

Exclusion Criteria

A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation

A Platform Protocol to Investigate Post-Transplant Cyclophosphamide-Based Graft-Versus-Host Disease Prophylaxis in Patients With Hematologic Malignancies Undergoing Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation

A Study of 14C-Bleximenib (Radiolabeled) in Participants With Acute Leukemia

Venetoclax Basket Trial for High Risk Hematologic Malignancies

Graft Versus Host Disease-Reduction Strategies for Donor Blood Stem Cell Transplant Patients With Acute Leukemia or Myelodysplastic Syndrome (MDS)

Study of Revumenib, Azacitidine, and Venetoclax in Pediatric and Young Adult Patients With Refractory or Relapsed Acute Myeloid Leukemia