RecruitingPhase 1Phase 2NCT04988555

A Phase 1/2 Study of Enzomenib (DSP-5336) in Patients With Acute Leukemia (Horizen-1)

A Phase 1/2, Open-Label, Dose-Escalation, Dose-Expansion Study of Enzomenib (DSP-5336) in Patients With Acute Leukemia and Other Selected Hematologic Malignancies, With and Without Mixed Lineage Leukemia (MLL) Rearrangement or Nucleophosmin 1 (NPM1) Mutation (Horizen-1)

Sponsor

Sumitomo Pharma America, Inc.

Enrollment

606 participants

Start Date

Feb 28, 2022

Study Type

INTERVENTIONAL

Conditions

Multiple Myeloma Myelodysplastic Syndromes Leukemia, Myeloid, Acute Leukemia, Lymphocytic, Acute

Summary

A phase 1/2 dose escalation / dose expansion study of Enzomenib (DSP-5336) in patients with acute leukemia.

Eligibility

Min Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new drug called DSP-5336 — which targets a protein called menin involved in leukemia growth — in people with relapsed or treatment-resistant acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), or related blood cancers. A Phase 1 dose-escalation study with Phase 2 expansion cohorts. **You may be eligible if...** - You have relapsed or refractory AML, ALL, or another acute leukemia that has stopped responding to standard treatments - In the US, you may also qualify if you have high-risk myelodysplastic syndrome (MDS) or multiple myeloma (MM) that has progressed after multiple prior therapies - For combination cohorts: your leukemia has a specific genetic change (MLL rearrangement or NPM1 mutation) **You may NOT be eligible if...** - Your blood counts, organ function, or performance status do not meet study thresholds - You have active uncontrolled infection or other serious medical conditions - Your leukemia type is not covered under the study criteria 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

DRUGEnzomenib

DSP-5336 orally

DRUGazoles

Posaconazole, Voriconazole, or Fluconazole

DRUGVenetoclax

Venetoclax orally

DRUGGilteritinib

Gilteritinib orally

DRUGAzacitidine (AZA)

Azacitidine orally

DRUGIntensive chemotherapy with 7 + 3

chemotherapy

Locations(104)

Hoag Family Cancer Center

Newport Beach, California, United States

Stanford University

Palo Alto, California, United States

Colorado Blood Cancer Institute

Denver, Colorado, United States

Georgetown Lombardi Comprehensive Cancer Center

Washington D.C., District of Columbia, United States

University of Miami

Miami, Florida, United States

Miami Cancer Institute

Miami, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

Northwestern

Chicago, Illinois, United States

Sibley Memorial Hospital

Baltimore, Maryland, United States

University of Maryland

Baltimore, Maryland, United States

Johns Hopkins Main Center

Baltimore, Maryland, United States

Tufts University

Boston, Massachusetts, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Atlantic Health

Morristown, New Jersey, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Roswell Park Comprehensive Cancer Center

Buffalo, New York, United States

Mount Sinai Hospital

New York, New York, United States

Columbia University

New York, New York, United States

UNC Hospital

Chapel Hill, North Carolina, United States

Duke University

Durham, North Carolina, United States

Atrium Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, United States

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Oncology Associates of Oregon

Eugene, Oregon, United States

Sidney Kimmel Comprehensive Cancer Center

Philadelphia, Pennsylvania, United States

Allegheny Health Network

Pittsburgh, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

TriStar Centennial Medical Center

Nashville, Tennessee, United States

MDACC

Houston, Texas, United States

Huntsman Cancer Institute

Salt Lake City, Utah, United States

Intermountain Healthcare

Salt Lake City, Utah, United States

University of Virginia

Charlottesville, Virginia, United States

Virginia Cancer Specialists

Fairfax, Virginia, United States

Virginia Oncology Associates

Norfolk, Virginia, United States

ZNA Cadix

Antwerp, Belgium

UZ Ghent

Ghent, Belgium

University Hospitals Leuven

Leuven, Belgium

AZ Delta

Roeselare, Belgium

Tom Baker Cancer Center

Calgary, Alberta, Canada

University of Alberta

Edmonton, Canada

Centre Hospitalier Universitaire d'Angers

Angers, France

Hopital Avicenne

Bobigny, France

Centre Hospitalier Le Mans

Le Mans, France

Hopital Claude Huriez

Lille, France

Centre Hospitalier Universitaire de Limoges

Limoges, France

Hospices Civils de Lyon

Lyon, France

Institut Paoli-Calmettes

Marseille, France

CHU de Nantes

Nantes, France

CHU de Nice - Hôpital l'Archet 1

Nice, France

Hopital Saint-Louis

Paris, France

CHU Bordeaux

Talence, France

Institut Gustave Roussy

Villejuif, France

IRCCS Azienda Ospedaliero-Universitaria Di Bologna, Policlinico Sant'Orsola

Bologna, Italy

Ospedale di Busto Arsizio

Busto Arsizio, Italy

Ospedale Policlinico San Martino, IRCCS

Genoa, Italy

IRCCS istituto Romagnolo per lo studio dei tumori "Dino Amadori"

Meldola, Italy

Istituto Oncologico Veneto (IOV), IRCCS

Padua, Italy

Università degli Studi di Perugia

Perugia, Italy

Azienda USL della Romagna, Ospedale Santa Maria delle Croci di Ravenna

Ravenna, Italy

PU A. Gemelli, Università Cattolica del Sacro Cuore

Rome, Italy

Universita' Degli Studi Di Torino

Turin, Italy

National Cancer Center Hospital East

Kashiwa-shi, Chiba, Japan

University of Fukui Hospital

Yoshida-gun, Fukui, Japan

Fukushima Medical University Hospital

Fukushima, Fukushima, Japan

Tokai University Hospital

Isehara-shi, Kanagawa, Japan

Nagasaki University Hospital

Nagasaki, Nagasaki, Japan

Nippon Medical School Hospital

Bunkyo-ku, Tokyo, Japan

Tokyo Metropolitan Komagome Hospital

Bunkyō City, Japan

Kyushu University Hospital

Fukuoka, Japan

Hokkaido University Hospital

Hokkaido, Japan

Tohoku University Hospital

Miyagi, Japan

Okayama University Hospital

Okayama, Japan

Osaka University Hospital

Osaka, Japan

National University Cancer Institute

Singapore, Singapore

Chonnam National University Hwasun Hospital

Hwasun, South Korea

Samsung Medical Center

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

The Catholic University of Korea

Seoul, South Korea

Hospital General Universitario De Albacete

Albacete, Spain

Hospital Universitari Vall D'Hebron

Barcelona, Spain

Institut Catala d'Oncologia

Barcelona, Spain

Hospital San Pedro de Alcantara

Cáceres, Spain

Hospital Universitario De Gran Canaria Dr. Negrin

Las Palmas, Spain

MD Anderson Cancer Center

Madrid, Spain

Hospital Universitario Central De Asturias

Oviedo, Spain

Hospital Universitario de Salamanca

Salamanca, Spain

Fundacion Instituto de Investigacion Marques de Valdecilla

Santander, Spain

Complexo Hospitalario Universitario De Santiago

Santiago de Compostela, Spain

Hospital Universitario y Politecnico La Fe

Valencia, Spain

University Hospital Basel

Basel, Switzerland

University Hospital Bern Inselspital

Bern, Switzerland

Universitaetsspital Zuerich - Haematology

Zurich, Switzerland

Taichung Veterans General Hospital

Taichung, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

University Hospitals of Birmingham Centre for Clinical Hematology

Birmingham, United Kingdom

Bristol Hematology & Oncology Centre

Bristol, United Kingdom

NHS Lothian Western General

Edinburgh, United Kingdom

King's College Hospital

London, United Kingdom

Sarah Cannon Research Institute

London, United Kingdom

University College London Hospitals NHS Foundation Trust

London, United Kingdom

Christie Hospital NHS Foundation Trust

Manchester, United Kingdom

Churchill Hospital Oxford

Oxford, United Kingdom

University Hospitals of North Midlands NHS Foundation Trust

Stoke-on-Trent, United Kingdom

The Royal Marsden NHS Foundation Trust

Sutton, United Kingdom

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