Phase
Condition
Leukemia
Treatment
JNJ-75276617
Daunorubicin or Idarubicin
Azacitidine (AZA)
Clinical Study ID
Ages > 12 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Adolescent participants (defined as greater than or equal to [>=] 12 and less than [<] 18 years of age) are only eligible for the relapsed/refractory (R/R) cohort (ArmA, cohort A4)
Diagnosis of AML according to World Health Organization (WHO) criteria: a) De novoor secondary AML; b) relapsed/refractory (Arm A only); c) harboring KMT2A, NPM1,NUP98, or NUP214 alterations; d) Participants may receive emergency leukapheresisand/or cytarabine as cytoreductive therapy according to local practice guidelines
Pretreatment clinical laboratory values meeting the following criteria -listedbelow: White blood cell (WBC) count: less than or equal to (<=) 25*10^9 per liter (/L), adequate liver and renal function
Eastern Cooperative Oncology Group (ECOG) performance status grade of 0, 1 or 2.Adolescent participants only: Performance status >70 by Lansky scale (forparticipants <16 years of age) or >70 Karnofsky scale (for participants >16 years ofage)
A female of childbearing potential must have a negative highly sensitive serumbeta-human chorionic gonadotropin at screening and within 48 hours prior to thefirst dose of study treatment
Must sign an informed consent form (ICF) indicating participant (or their legallyauthorized representative) understands the purpose of the study and proceduresrequired for the study and is willing to participate in the study
Willing and able to adhere to the prohibitions and restrictions specified in thisprotocol
Exclusion
Exclusion Criteria:
Acute promyelocytic leukemia, diagnosis of Down syndrome associated leukemia orjuvenile myelomonocytic 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 Pointesor that was diagnosed within 6 months prior to the first dose of study treatmentincluding, but not limited to: (a) Myocardial infarction; (b) Severe or unstableangina; (c) Clinically significant cardiac arrhythmias, including bradycardia (<50beats per minute); (d) Uncontrolled (persistent) hypertension: (example, bloodpressure greater than [>] 140/90 millimeters of mercury [mm Hg]; (e) Acuteneurologic events such as stroke or transient ischemic attack, intracranial orsubarachnoid hemorrhage, intracranial trauma; (f) Venous thromboembolic events (example, pulmonary embolism) within 1 month prior to the first dose of studytreatment ;(g) Congestive heart failure (NYHA class III to IV); (h) Pericarditis orclinically significant pericardial effusion; (i) Myocarditis; (j) Endocarditis (k)Clinically significant hypokalemia, hypomagnesemia, hypocalcemia (corrected forhypoalbuminemia)
Any toxicity (except for alopecia, stable peripheral neuropathy, thrombocytopenia,neutropenia, anemia) from previous anticancer therapy that has not resolved tobaseline or to grade 1 or less
Pulmonary compromise that requires the need for supplemental oxygen use to maintainadequate oxygenation
Participants with diagnosis of Fanconi anemia, Kostmann syndrome, Shwachman diamondsyndrome, or any other known bone marrow failure syndrome
Study Design
Connect with a study center
Monash Medical Centre
Clayton, 3168
AustraliaSite Not Available
Monash Medical Centre
Clayton 2171400, 3168
AustraliaActive - Recruiting
Peter MacCallum Cancer Centre
Melbourne, 3000
AustraliaSite Not Available
Peter MacCallum Cancer Centre
Melbourne 2158177, 3000
AustraliaActive - Recruiting
Westmead Hospital
Westmead, 2145
AustraliaSite Not Available
Westmead Hospital
Westmead 2143973, 2145
AustraliaActive - Recruiting
Princess Margaret Cancer Centre University Health Network
Toronto, Ontario M5G 1Z5
CanadaSite Not Available
Princess Margaret Cancer Centre University Health Network
Toronto 6167865, Ontario 6093943 M5G 1Z5
CanadaSite Not Available
Institut Paoli Calmettes
Marseille 2995469, 13273
FranceSite Not Available
Institut Paoli Calmettes
Marseille Cedex 9, 13273
FranceSite Not Available
Chu Rennes Hopital Pontchaillou
Rennes 2983990, 35033
FranceActive - Recruiting
Chu Rennes - Hopital Pontchaillou
Rennes Cedex 9, 35033
FranceSite Not Available
Chu Rennes Hopital Pontchaillou
Rennes Cedex 9, 35033
FranceSite Not Available
Institut Universitaire du Cancer Toulouse Oncopole
Toulouse 2972315, 31100
FranceActive - Recruiting
Institut Universitaire du Cancer Toulouse Oncopole
Toulouse Cedex 9, 31100
FranceSite Not Available
CHU de Tours - Hôpital de Bretonneau
Tours, 37044
FranceSite Not Available
CHU de Tours - Hôpital de Bretonneau
Tours 2972191, 37044
FranceActive - Recruiting
Charite Universitaetsmedizin Berlin
Berlin, 13353
GermanySite Not Available
Charite Universitatsmedizin Berlin
Berlin, 13353
GermanyActive - Recruiting
Charité Universitätsmedizin Berlin
Berlin, 13353
GermanyActive - Recruiting
Charite Universitaetsmedizin Berlin
Berlin 2950159, 13353
GermanySite Not Available
Universitatsklinikum Carl Gustav Carus Dresden
Dresden, 01307
GermanySite Not Available
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, 01307
GermanyActive - Recruiting
Universitatsklinikum Carl Gustav Carus Dresden
Dresden 2935022, 01307
GermanySite Not Available
Universitaetsklinikum Heidelberg
Heidelberg, 69120
GermanySite Not Available
Universitätsklinikum Heidelberg
Heidelberg, 69120
GermanyActive - Recruiting
Universitaetsklinikum Heidelberg
Heidelberg 2907911, 69120
GermanySite Not Available
Universitaetsklinikum Leipzig
Leipzig, 04103
GermanySite Not Available
Universitatsklinikum Leipzig
Leipzig, 04103
GermanyActive - Recruiting
Universitaetsklinikum Leipzig
Leipzig 2879139, 04103
GermanyCompleted
Universitatsklinikum Ulm
Ulm, 89081
GermanySite Not Available
Universitätsklinikum Ulm
Ulm, 89081
GermanyActive - Recruiting
Universitatsklinikum Ulm
Ulm 2820256, 89081
GermanySite Not Available
Azienda Opedaliero-Universitaria Policlinico Sant'orsola Malpighi di Bologna
Bologna, 40138
ItalySite Not Available
Azienda Opedaliero-Universitaria Policlinico Sant'orsola Malpighi di Bologna
Bologna 3181928, 40138
ItalyActive - Recruiting
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola, 47014
ItalySite Not Available
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola 3173635, 47014
ItalyActive - Recruiting
ASST Grande Ospedale Metropolitano Niguarda
Milan 6951411, 20162
ItalyActive - Recruiting
ASST Grande Ospedale Metropolitano Niguarda
Milano, 20162
ItalySite Not Available
IRCCS Istituto Clinico Humanitas
Rozzano, 20089
ItalySite Not Available
IRCCS Istituto Clinico Humanitas
Rozzano 3168837, 20089
ItalyActive - Recruiting
Hosp Clinic de Barcelona
Barcelona, 08036
SpainSite Not Available
Hosp Univ Vall D Hebron
Barcelona, 8035
SpainActive - Recruiting
Hosp. Clinic I Provincial de Barcelona
Barcelona, 08036
SpainActive - Recruiting
Hosp. Clinic de Barcelona
Barcelona, 08036
SpainActive - Recruiting
Hosp. Univ. Vall D Hebron
Barcelona, 8035
SpainActive - Recruiting
Hosp. de La Santa Creu I Sant Pau
Barcelona, 08025
SpainActive - Recruiting
Hosp. de la Santa Creu i Sant Pau
Barcelona, 08041
SpainActive - Recruiting
Hosp Clinic de Barcelona
Barcelona 3128760, 08036
SpainActive - Recruiting
Hosp Univ Vall D Hebron
Barcelona 3128760, 8035
SpainActive - Recruiting
Hosp. de La Santa Creu I Sant Pau
Barcelona 3128760, 08025
SpainActive - Recruiting
Hosp Univ Fund Jimenez Diaz
Madrid, 28040
SpainSite Not Available
Hosp. Univ. Fund. Jimenez Diaz
Madrid, 28040
SpainActive - Recruiting
Hosp Univ Fund Jimenez Diaz
Madrid 3117735, 28040
SpainActive - Recruiting
Clinica Univ. de Navarra
Pamplona, 31008
SpainSite Not Available
Clinica Univ. de Navarra
Pamplona 3114472, 31008
SpainActive - Recruiting
University College London Hospitals NHSFT
London, NW1 2PG
United KingdomSite Not Available
University College London Hospitals NHSFT
London 2643743, NW1 2PG
United KingdomActive - Recruiting
Christie Hospital NHS Trust
Manchester, M20 4BX
United KingdomSite Not Available
Christie Hospital NHS Trust
Manchester 2643123, M20 4BX
United KingdomActive - Recruiting
Oxford University Hospitals NHS Trust
Oxfordshire, OX3 7LE
United KingdomSite Not Available
The University of Alabama at Birmingham
Birmingham, Alabama 35233
United StatesSite Not Available
The University of Alabama at Birmingham
Birmingham 4049979, Alabama 4829764 35233
United StatesCompleted
City of Hope
Duarte, California 91010
United StatesSite Not Available
University of Southern California
Los Angeles, California 90033
United StatesSite Not Available
City of Hope
Duarte 5344147, California 5332921 91010
United StatesActive - Recruiting
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesSite Not Available
Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926 02114
United StatesActive - Recruiting
Albert Einstein College Of Medicine
New York, New York 10461
United StatesSite Not Available
Albert Einstein College Of Medicine
New York 5128581, New York 5128638 10461
United StatesActive - Recruiting
Novant Health
Charlotte, North Carolina 28204
United StatesSite Not Available
Novant Health Forsyth Medical Center
Winston-Salem, North Carolina 27103
United StatesSite Not Available
Novant Health
Charlotte 4460243, North Carolina 4482348 28204
United StatesActive - Recruiting
Novant Health Forsyth Medical Center
Winston-Salem 4499612, North Carolina 4482348 27103
United StatesActive - Recruiting
MD Anderson
Houston, Texas 77030
United StatesSite Not Available
MD Anderson
Houston 4699066, Texas 4736286 77030
United StatesActive - Recruiting
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