RecruitingPhase 1Phase 2NCT04065399

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

A Phase 1/2, Open-label, Dose-Escalation and Dose-Expansion Cohort Study of SNDX-5613 in Patients With Relapsed/Refractory Leukemias, Including Those Harboring an MLL/KMT2A Gene Rearrangement or Nucleophosmin 1 (NPM1) Mutation

Sponsor

Syndax Pharmaceuticals

Enrollment

447 participants

Start Date

Nov 5, 2019

Study Type

INTERVENTIONAL

Conditions

Acute Lymphoblastic Leukemia Acute Myeloid Leukemia Mixed Phenotype Acute Leukemia Acute Leukemia of Ambiguous Lineage Mixed Lineage Acute Leukemia

Summary

Phase 1 dose escalation will determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of revumenib in participants with acute leukemia. In Phase 2, participants will be enrolled in 4 indication-specific expansion cohorts to determine the efficacy, short- and long-term safety, and tolerability of revumenib.

Eligibility

Min Age: 30 Days

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called revumenib in people with relapsed or treatment-resistant leukemia (blood cancer that has come back or stopped responding to treatment), particularly those with specific genetic changes in their cancer cells — specifically KMT2A rearrangement or NPM1 mutation. **You may be eligible if...** - You have been diagnosed with active acute leukemia that has come back or is not responding to treatment - Your leukemia has specific genetic markers: KMT2A rearrangement, NUP98 rearrangement, or NPM1 mutation - You have detectable disease in your bone marrow - You have tried standard available treatments **You may NOT be eligible if...** - You do not have one of the specific genetic mutations the study is targeting - You have not tried standard therapies first - You have significant organ dysfunction or certain drug interactions that could interfere with the study medication Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGrevumenib

revumenib orally

DRUGcobicistat

Phase 1 Arm C participants will receive 150 mg cobicistat daily.

Locations(57)

City of Hope Comprehensive Cancer Center

Duarte, California, United States

University Of California Care Medical Group - Norris Comprehensive Cancer Center And Hospital

Los Angeles, California, United States

Stanford Cancer Institute

Palo Alto, California, United States

University of Colorado

Aurora, Colorado, United States

Florida Cancer Specialists and Research Institute

Sarasota, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

Emory Winship Cancer Institute

Atlanta, Georgia, United States

Children's Healthcare of Atlanta

Atlanta, Georgia, United States

The University of Chicago Medical Center

Chicago, Illinois, United States

University of Iowa Hospital

Iowa City, Iowa, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Washington University in St. Louis School of Medicine

St Louis, Missouri, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Montefiore Medical Center

New York, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

University of Cincinnati

Cincinnati, Ohio, United States

Ohio State University

Columbus, Ohio, United States

Oregon Health & Science University

Portland, Oregon, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Huntsman Cancer Institute at the University of Utah

Salt Lake City, Utah, United States

Peter MacCallum Cancer Centre (PMCC)

Melbourne, Victoria, Australia

Royal Melbourne Hospital (RMH)

Parkville, Victoria, Australia

Alfred Hospital

Melbourne, Australia

Sir Charles Gairdner Hospital

Nedlands, Australia

Royal North Shore Hospital

Saint Leonards, Australia

University Health Network

Toronto, Canada

The Hospital for Sick Children

Toronto, Canada

Hospital Saint-Louis - APHP

Paris, France

Centre Hospitalier Universitaire (CHU) de Bordeaux

Pessac, France

Centre Hospitalier Lyon Sud

Pierre-Bénite, France

Institut Gustave Roussy-Gustave Roussy Cancer Center -DITEP

Villejuif, France

University Hospital Of Ulm, Universitatsklinikum Ulm

Ulm, Baden-Wurttemberg, Germany

Universitaetsklinikum Essen (AoR)

Essen, Germany

Universitaetsmedizin Greifswald

Greifswald, Germany

Universitaetsmedizin Der Johannes

Gutenberg, Germany

Universitaetsklinikum Hamburg-Eppendorf

Hamburg, Germany

University of Leipzig

Leipzig, Germany

Klinikum Nuernberg Nord

Nuremberg, Germany

Rambam Health Care Campus (RHCC)

Haifa, Israel

Shaare Zedek Medical Center

Jerusalem, Israel

Hadassah Medical Center- Ein Kerem

Jerusalem, Israel

Galilee Medical Center

Nahariya, Israel

Rabin Medical Center

Petah Tikva, Israel

Sheba Medical Center

Ramat Gan, Israel

IRCCS Azienda Ospedaliero Universitaria di Bologna

Bologna, Italy

Istituto Romagnolo Per Lo Studio dei tumori Dino Amadori

Meldola, Italy

IRCCS-Istituto Europeo di Oncologia

Milan, Italy

Universita Cattolica Fondazione Policlinico Agostino Gemelli

Roma, Italy

S Bortolo Hospital AULSS 8 Berica

Vicenza, Italy

Vilnius University Hospital Santaros Klinikos

Vilnius, Lithuania

Princess Maxima Center for Pediatric Oncology

Utrecht, Netherlands

Hospital Centro Comprensivo de Cancer UPR

San Juan, Puerto Rico

Institut Catala d'Oncologia (ICO) - Hospital Duran i Reynals

L'Hospitalet de Llobregat, Spain

Hospital Universitario Virgen del Rocio

Seville, Spain

Hospital Universitari i Politecnic La Fe de Valencia

Valencia, Spain

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NCT04065399

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