Phase
Condition
Leukemia
Treatment
Bleximenib
Cytarabine
Venetoclax (VEN)
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
AustraliaActive - Recruiting
Peter MacCallum Cancer Centre
Melbourne, 3000
AustraliaActive - Recruiting
Westmead Hospital
Westmead, 2145
AustraliaActive - Recruiting
Princess Margaret Cancer Centre University Health Network
Toronto, Ontario M5G 1Z5
CanadaActive - Recruiting
Institut Paoli Calmettes
Marseille Cedex 9, 13273
FranceActive - Recruiting
Chu Rennes - Hopital Pontchaillou
Rennes Cedex 9, 35033
FranceSite Not Available
Chu Rennes Hopital Pontchaillou
Rennes Cedex 9, 35033
FranceActive - Recruiting
Institut Universitaire du Cancer Toulouse Oncopole
Toulouse Cedex 9, 31100
FranceActive - Recruiting
CHU de Tours - Hôpital de Bretonneau
Tours, 37044
FranceActive - Recruiting
Charite Universitaetsmedizin Berlin
Berlin, 13353
GermanyActive - Recruiting
Charite Universitatsmedizin Berlin
Berlin, 13353
GermanyActive - Recruiting
Charité Universitätsmedizin Berlin
Berlin, 13353
GermanyActive - Recruiting
Universitatsklinikum Carl Gustav Carus Dresden
Dresden, 01307
GermanyActive - Recruiting
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, 01307
GermanyActive - Recruiting
Universitaetsklinikum Heidelberg
Heidelberg, 69120
GermanyActive - Recruiting
Universitätsklinikum Heidelberg
Heidelberg, 69120
GermanyActive - Recruiting
Universitaetsklinikum Leipzig
Leipzig, 04103
GermanyActive - Recruiting
Universitatsklinikum Leipzig
Leipzig, 04103
GermanyActive - Recruiting
Universitatsklinikum Ulm
Ulm, 89081
GermanyActive - Recruiting
Universitätsklinikum Ulm
Ulm, 89081
GermanyActive - Recruiting
Azienda Opedaliero-Universitaria Policlinico Sant'orsola Malpighi di Bologna
Bologna, 40138
ItalyActive - Recruiting
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola, 47014
ItalyActive - Recruiting
ASST Grande Ospedale Metropolitano Niguarda
Milano, 20162
ItalyActive - Recruiting
IRCCS Istituto Clinico Humanitas
Rozzano, 20089
ItalyActive - Recruiting
Hosp Clinic de Barcelona
Barcelona, 08036
SpainActive - Recruiting
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 Univ Fund Jimenez Diaz
Madrid, 28040
SpainActive - Recruiting
Hosp. Univ. Fund. Jimenez Diaz
Madrid, 28040
SpainActive - Recruiting
Clinica Univ. de Navarra
Pamplona, 31008
SpainActive - Recruiting
University College London Hospitals NHSFT
London, NW1 2PG
United KingdomActive - Recruiting
Christie Hospital NHS Trust
Manchester, M20 4BX
United KingdomActive - Recruiting
Oxford University Hospitals NHS Trust
Oxfordshire, OX3 7LE
United KingdomActive - Recruiting
The University of Alabama at Birmingham
Birmingham, Alabama 35233
United StatesActive - Recruiting
City of Hope
Duarte, California 91010
United StatesActive - Recruiting
University of Southern California
Los Angeles, California 90033
United StatesSite Not Available
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesActive - Recruiting
Albert Einstein College Of Medicine
New York, New York 10461
United StatesActive - Recruiting
Novant Health
Charlotte, North Carolina 28204
United StatesActive - Recruiting
Novant Health Forsyth Medical Center
Winston-Salem, North Carolina 27103
United StatesActive - Recruiting
MD Anderson
Houston, Texas 77030
United StatesActive - Recruiting
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