Acute Myeloid Leukemia Clinical Trial

A Study of JNJ-75276617 in Participants With Acute Leukemia

Summary

The purpose of this study is to determine the recommended Phase 2 dose(s) (RP2D[s]) of JNJ-75276617 in Part 1 (Dose Escalation) and to determine safety and tolerability at the RP2D(s) in Part 2 (Dose Expansion).

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Full Description

Acute myeloid leukemia (AML) is a heterogeneous disease characterized by uncontrolled clonal expansion of hematopoietic progenitor cells (myeloid blasts) in the peripheral blood, bone marrow, and other tissues. Acute lymphoblastic leukemia (ALL) is a hematologic malignancy propagated by impaired differentiation, proliferation, and accumulation of lymphoid progenitor cells in the bone marrow and/or extramedullary sites. 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 primary goal of this FIH study is to establish the recommended Phase 2 dose (RP2D) of JNJ-75276617 with an acceptable safety profile. The total duration of the study is up to 2 years and 10 months. Safety assessment will include adverse events (AEs), serious adverse events (SAEs), physical examination, Eastern Cooperative Oncology Group (ECOG) performance status, vital signs, electrocardiogram, clinical safety laboratory assessment and pregnancy testing.

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Eligibility Criteria

Inclusion Criteria:

Relapsed or refractory acute leukemia and has exhausted, or is ineligible for, available therapeutic options
Acute leukemia harboring histone-lysine N-methyltransferase 2A (KMT2A) or nucleophosmin 1 gene (NPM1) alterations
Pretreatment clinical laboratory values meeting the following criteria: (a) Hematology: white blood cell (WBC) count less than or equal to (<=) 30 * 10^9/liter (L) (hydroxyurea may be used to lower WBC count at screening and during study; (b) Chemistry: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <=2.5 * upper limit of normal (ULN), total serum bilirubin <= 1.5 * ULN (participants with elevated bilirubinemia, such as Gilbert's syndrome, may enroll if conjugated bilirubin is within clinically acceptable range) and renal function; Estimated or measured glomerular filtration rate greater than or equal to (>=) 60 milliliter per minute (mL/min)/1.73 meter square (m^2) per four variable modified diet in renal disease (MDRD) equation
Eastern Cooperative Oncology Group (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
A male must agree to all the following during the study and for 90 days after the last dose of study treatment: A male must agree to all the following during the study and for 90 days after the last dose of study treatment: (a) wear a condom when engaging in any activity that allows for passage of ejaculate to another person; (b) not to donate sperm or freeze for future use for the purpose of reproduction. In addition, the participant should be advised of the benefit for a female partner to use a highly effective method of contraception as condom may break or leak

Exclusion Criteria:

Acute promyelocytic leukemia according to World Health Organization (WHO) 2016 criteria
Active central nervous system (CNS) disease
Prior solid organ transplantation
QTc according to Fridericia's formula (QTcF) for males >= 450 millisecond (msec) or for females >= 470 msec. Participants with a family history of Long QT syndrome are excluded
Exclusion criteria related to stem cell transplant: a. Willing and able to undergo allogeneic stem cell transplant (if clinically indicated); b. Received prior treatment with allogenic bone marrow or stem cell transplant <=3 months before the first dose of study treatment; c. Has evidence of graft versus host disease; d. Received donor lymphocyte infusion <=1 month before the first dose of study treatment; e. Requires immunosuppressant therapy (exception: daily doses <=10 milligrams (mg) prednisone or equivalent are allowed for adrenal replacement)
Chemotherapy, targeted therapy, immunotherapy, or radiotherapy within 4 weeks or 5 half-lives (whichever is shorter) before the planned first dose of study treatment

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

110

Study ID:

NCT04811560

Recruitment Status:

Recruiting

Sponsor:

Janssen Research & Development, LLC

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There are 29 Locations for this study

See Locations Near You

City of Hope
Duarte California, 91010, United States
University of California Irvine Medical Center
Orange California, 92868, United States
University of California San Francisco
San Francisco California, 94143, United States
University of Chicago Medical Center
Chicago Illinois, 60637, United States
Norton Cancer Institute
Louisville Kentucky, 40207, United States
Johns Hopkins Hospital
Baltimore Maryland, 21287, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Dana Farber Cancer Institute
Boston Massachusetts, 02215, 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
University of Virginia
Charlottesville Virginia, 22908, United States
Medical College of WI at Froedtert
Milwaukee Wisconsin, 53226, United States
Monash Medical Centre
Clayton , VIC 3, Australia
Royal Perth Hospital
Perth , 6000, Australia
Gold Coast University Hospital
Southport , 4215, Australia
Institut Paoli Calmettes
Marseille , 13009, France
CHU de Nantes hôtel-Dieu
Nantes Cedex 1 , 44093, France
Centre Hospitalier Universitaire (CHU) de Bordeaux Hopital HautLeveque Centre Francois Magendie
Pessac , 33604, France
Institut Universitaire du Cancer Toulouse Oncopole
Toulouse , 31059, France
CHU Bretonneau
Tours cedex , 37044, France
Hosp. Univ. Vall D Hebron
Barcelona , 08035, Spain
Hosp. Clinic I Provincial De Barcelona
Barcelona , 08036, Spain
Hosp. Univ. Fund. Jimenez Diaz
Madrid , 28040, Spain
Clinica Univ. de Navarra
Pamplona , 31008, Spain
Guy's and St Thomas' NHS Foundation Trust
London , SE1 9, United Kingdom
The Christie Nhs Foundation 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:

110

Study ID:

NCT04811560

Recruitment Status:

Recruiting

Sponsor:


Janssen Research & Development, LLC

How clear is this clinincal trial information?

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