Spots Global Cancer Trial Database for A Study of JNJ-75276617 in Combination With Acute Myeloid Leukemia (AML) Directed Therapies
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: A Study of JNJ-75276617 in Combination With Acute Myeloid Leukemia (AML) Directed Therapies
Official Title: A Phase 1b Study of JNJ-75276617 in Combination With AML-Directed Therapies for Participants With Acute Myeloid Leukemia Harboring KMT2A or NPM1 Alterations
Study ID: NCT05453903
Conditions
Study Description
Brief Summary: The purpose of this study is to determine the recommended Phase 2 dose (RP2D) candidate(s) of JNJ-75276617 in combination with AML directed therapies (dose selection) and further to evaluate safety and tolerability of JNJ-75276617 in combination with AML directed therapies at the RP2D(s) (dose expansion).
Detailed Description: AML is a heterogenous disease characterized by uncontrolled clonal expansion of hematopoietic progenitor cells (myeloid blasts) in the peripheral blood, bone marrow and other tissues and is the most common type of acute leukemia in adults. JNJ-75276617 is an orally bioavailable, potent, and selective protein-protein interaction inhibitor of the binding between histone-lysine N-methyltransferase 2A (\[KMT2A\], also called mixed-lineage leukemia 1 \[MLL1\]; wild-type and fusion) and menin, with activity in leukemic cell lines and primary leukemia patient or patient-derived samples with either KMT2A alterations including gene rearrangements (KMT2A-r), duplications, and amplification, or nucleophosmin 1 gene (NPM1) alterations. The aim of this study is to determine the RP2D(s), safety, pharmacokinetic, pharmacodynamic and preliminary clinical activity of JNJ-75276617 in combination with AML directed therapies for adult participants with relapsed/refractory or newly diagnosed AML with NPM1 or KMT2A gene alterations and will include dose selection and subsequent combination specific dose expansion. The total study duration will be up to 2 years. Safety evaluations include adverse events (AE) monitoring, clinical laboratory tests, electrocardiograms (ECGs), vital sign measurements, physical examination findings, and eastern cooperative oncology group (ECOG) performance status score.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Institut Paoli Calmettes, Marseille Cedex 9, , France
Institut Universitaire du Cancer Toulouse Oncopole, Toulouse Cedex 9, , France
CHU de Tours - Hôpital de Bretonneau, Tours, , France
Charite Universitatsmedizin 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, Milano, , 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
Contact Details
Name: Janssen Research & Development, LLC Clinical Trial
Affiliation: Janssen Research & Development, LLC
Role: STUDY_DIRECTOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
