Acute Myeloid Leukemia Clinical Trial

A Study of JNJ-75276617 in Combination With Acute Myeloid Leukemia (AML) Directed Therapies

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).

View Full Description

Full 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 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Diagnosis of AML according to World Health Organization (WHO) 2016 criteria a) De novo or secondary AML; b) relapsed /refractory (Arm A); c) harboring NPM1 / KMT2A alterations
Pretreatment clinical laboratory values meeting the following criteria -listed below: White blood cell (WBC) count: less than or equal to <=25 x 10^9 per liter (/L), adequate liver and renal function
ECOG performance status grade of 0, 1 or 2
A woman of childbearing potential must have a negative highly sensitive serum beta-human chorionic gonadotropin at screening and within 48 hours prior to the first dose of study treatment
Must sign an informed consent form (ICF) indicating participant understands the purpose of the study and procedures required for the study and is willing to participate in the study.
Willing and able to adhere to the prohibitions and restrictions specified in this protocol

Exclusion Criteria:

Acute promyelocytic leukemia according to WHO 2016 criteria
Leukemic involvement of the central nervous system
Recipient of solid organ transplant
Cardiovascular disease that is uncontrolled, increases risk for Torsades de Pointes or that was diagnosed within 6 months prior to the first dose of study treatment including, but not limited to:(a) Myocardial infarction; (b) Severe or unstable angina; (c) Clinically significant cardiac arrhythmias, including bradycardia (less than [<] 50 beats per minute); (d) Uncontrolled (persistent) hypertension: (example, blood pressure greater than [>] 140/90 millimeters of mercury [mm Hg]; (e) Acute neurologic events such as stroke or transient ischemic attack, intracranial or subarachnoid hemorrhage, intracranial trauma; (f) Venous thromboembolic events (example, pulmonary embolism) within 1 month prior to the first dose of study treatment (uncomplicated Grade less than or equal to [≤]2 deep vein thrombosis is not considered exclusionary);(g)Congestive heart failure (NYHA class III to IV); (h) Pericarditis or clinically significant pericardial effusion; (i) Myocarditis; (j) Endocarditis (k) Clinically significant hypokalemia, hypomagnesemia, hypocalcemia (corrected for hypoalbuminemia)
Any toxicity (except for alopecia, stable peripheral neuropathy, thrombocytopenia, neutropenia, anemia) from previous anticancer therapy that has not resolved to baseline or to grade 1 or less
Pulmonary compromise that requires the need for supplemental oxygen use to maintain adequate oxygenation

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

150

Study ID:

NCT05453903

Recruitment Status:

Recruiting

Sponsor:

Janssen Research & Development, LLC

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 31 Locations for this study

See Locations Near You

The University of Alabama at Birmingham
Birmingham Alabama, 35233, United States
City of Hope
Duarte California, 91010, United States
University of Southern California
Los Angeles California, 90033, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
NYU Langone Medical Center
New York New York, 10016, United States
Novant Health
Charlotte North Carolina, 28204, United States
Novant Health Forsyth Medical Center
Winston-Salem North Carolina, 27103, United States
MD Anderson
Houston Texas, 77030, United States
Monash Medical Centre
Clayton , VIC 3, Australia
Peter MacCallum Cancer Centre
Melbourne , 3000, Australia
Westmead Hospital
Westmead , 2145, Australia
Institut Paoli Calmettes
Marseille Cedex 9 , 13273, France
Chu Rennes - Hopital Pontchaillou
Rennes Cedex 9 , 35033, France
Institut Universitaire du Cancer Toulouse Oncopole
Toulouse Cedex 9 , 31100, France
Charité Universitätsmedizin Berlin
Berlin , 13353, Germany
Universitätsklinikum Carl Gustav Carus Dresden
Dresden , 01307, Germany
Universitätsklinikum Heidelberg
Heidelberg , 69120, Germany
Universitatsklinikum Leipzig
Leipzig , 04103, Germany
Universitätsklinikum Ulm
Ulm , 89081, Germany
Azienda Opedaliero-Universitaria Policlinico Sant'orsola Malpighi di Bologna
Bologna , 40138, Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola , 47014, Italy
ASST Grande Ospedale Metropolitano Niguarda
Milano , 20162, Italy
IRCCS Istituto Clinico Humanitas
Rozzano , 20089, Italy
Hosp. Clinic I Provincial De Barcelona
Barcelona , 08036, Spain
Hosp. de La Santa Creu I Sant Pau
Barcelona , 08041, Spain
Hosp. Univ. Vall D Hebron
Barcelona , 8035, Spain
Hosp. Univ. Fund. Jimenez Diaz
Madrid , 28040, Spain
Clinica Univ. de Navarra
Pamplona , 31008, Spain
University College London Hospitals NHSFT
London , NW1 2, United Kingdom
Christie Hospital NHS Trust
Manchester , M20 4, United Kingdom
Oxford University Hospitals NHS Trust
Oxfordshire , OX3 7, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

150

Study ID:

NCT05453903

Recruitment Status:

Recruiting

Sponsor:


Janssen Research & Development, LLC

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.