Acute Myeloid Leukemia Clinical Trial
A Study of JNJ-75276617 in Combination With Acute Myeloid Leukemia (AML) Directed Therapies
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).
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.
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
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
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There are 31 Locations for this study
Birmingham Alabama, 35233, United States
Duarte California, 91010, United States
Los Angeles California, 90033, United States
Boston Massachusetts, 02114, United States
New York New York, 10016, United States
Charlotte North Carolina, 28204, United States
Winston-Salem North Carolina, 27103, United States
Houston Texas, 77030, United States
Clayton , VIC 3, Australia
Melbourne , 3000, Australia
Westmead , 2145, Australia
Marseille Cedex 9 , 13273, France
Rennes Cedex 9 , 35033, France
Toulouse Cedex 9 , 31100, France
Berlin , 13353, Germany
Dresden , 01307, Germany
Heidelberg , 69120, Germany
Leipzig , 04103, Germany
Ulm , 89081, Germany
Bologna , 40138, Italy
Meldola , 47014, Italy
Milano , 20162, Italy
Rozzano , 20089, Italy
Barcelona , 08036, Spain
Barcelona , 08041, Spain
Barcelona , 8035, Spain
Madrid , 28040, Spain
Pamplona , 31008, Spain
London , NW1 2, United Kingdom
Manchester , M20 4, United Kingdom
Oxfordshire , OX3 7, United Kingdom
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