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ACTIVE NOT RECRUITING
NCT05453903
PHASE1

A Study of Bleximenib in Combination With Acute Myeloid Leukemia (AML) Directed Therapies

Sponsor: Janssen Research & Development, LLC

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine the recommended Phase 2 dose (RP2D) candidate(s) of bleximenib in combination with AML directed therapies (dose selection) and further to evaluate safety and tolerability of bleximenib in combination with AML directed therapies at the RP2D(s) (dose expansion).

Official title: A Phase 1b Study of Bleximenib in Combination With AML-Directed Therapies for Participants With Acute Myeloid Leukemia Harboring KMT2A or NPM1 Alterations

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

INTERVENTIONAL

Enrollment

196

Start Date

2022-10-04

Completion Date

2027-03-19

Last Updated

2026-03-12

Healthy Volunteers

No

Interventions

DRUG

Bleximenib

Participants will receive bleximenib.

DRUG

Venetoclax (VEN)

Participants will receive VEN.

DRUG

Azacitidine (AZA)

Participants will receive AZA.

DRUG

Cytarabine

Participants will receive cytarabine.

DRUG

Daunorubicin or Idarubicin

Participants will receive daunorubicin or idarubicin.

Locations (32)

The University of Alabama at Birmingham

Birmingham, Alabama, United States

City of Hope

Duarte, California, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Albert Einstein College Of Medicine

New York, New York, United States

Novant Health

Charlotte, North Carolina, United States

Novant Health Forsyth Medical Center

Winston-Salem, North Carolina, United States

MD Anderson

Houston, Texas, United States

Monash Medical Centre

Clayton, Australia

Peter MacCallum Cancer Centre

Melbourne, Australia

Westmead Hospital

Westmead, Australia

Princess Margaret Cancer Centre University Health Network

Toronto, Ontario, Canada

Institut Paoli Calmettes

Marseille, France

Chu Rennes Hopital Pontchaillou

Rennes, France

Institut Universitaire du Cancer Toulouse Oncopole

Toulouse, France

CHU de Tours - Hôpital de Bretonneau

Tours, France

Charite Universitaetsmedizin Berlin

Berlin, Germany

Universitatsklinikum Carl Gustav Carus Dresden

Dresden, Germany

Universitaetsklinikum Heidelberg

Heidelberg, Germany

Universitaetsklinikum Leipzig

Leipzig, Germany

Universitatsklinikum Ulm

Ulm, Germany

Azienda Opedaliero-Universitaria Policlinico Sant'orsola Malpighi di Bologna

Bologna, Italy

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

Meldola, Italy

ASST Grande Ospedale Metropolitano Niguarda

Milan, Italy

IRCCS Istituto Clinico Humanitas

Rozzano, Italy

Hosp. de La Santa Creu I Sant Pau

Barcelona, Spain

Hosp Clinic de Barcelona

Barcelona, Spain

Hosp Univ Vall D Hebron

Barcelona, Spain

Hosp Univ Fund Jimenez Diaz

Madrid, Spain

Clinica Univ. de Navarra

Pamplona, Spain

University College London Hospitals NHSFT

London, United Kingdom

Christie Hospital NHS Trust

Manchester, United Kingdom

Oxford University Hospitals NHS Trust

Oxfordshire, United Kingdom