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Clinical Trials in the UK / NCT05453903
Active, not recruiting Phase 1

A Study of Bleximenib in Combination With Acute Myeloid Leukemia (AML) Directed Therapies

NCT05453903 · tracked via the Priya Life Science UK tracker
Sponsor
Janssen Research & Development, LLC
Phase
Phase 1
Started
2022-10-04
Last updated
2026-08-28

Condition(s) studied

Leukemia, Myeloid, Acute

Investigational drug(s) / intervention(s)

BleximenibVenetoclax (VEN)Azacitidine (AZA)CytarabineDaunorubicin or Idarubicin

Bleximenib: Participants will receive bleximenib.

Venetoclax (VEN): Participants will receive VEN.

Azacitidine (AZA): Participants will receive AZA.

Cytarabine: Participants will receive cytarabine.

Daunorubicin or Idarubicin: Participants will receive daunorubicin or idarubicin.

Study summary

The purpose of this study is to determine the recommended Phase 2 dose (RP2D) candidate(s) of bleximenib in combination with AML directed therapies (dose selection) and further to evaluate safety and tolerability of bleximenib in combination with AML directed therapies at the RP2D(s) (dose expansion).

Eligibility

Sex
ALL
Min age
12 Years
Max age
Healthy volunteers
No
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 (Arm A, cohort A4) * Diagnosis of AML according to World Health Organization (WHO) criteria: a) De novo or secondary AML; b) relapsed/refractory (Arm A only); c) harboring KMT2A, NPM1, NUP98, or NUP214 alterations; d) Participants may receive emergency leukapheresis and/or cytarabine as cytoreductive therapy according to local practice guidelines * Pretreatment clinical laboratory values meeting the following criteria -listed below: 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 (for participants \<16 years of age) or \>70 Karnofsky scale (for participants \>16 years of age) * A female 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 (or their legally authorized representative) 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, diagnosis of Down syndrome associated leukemia or juvenile 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 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 (\<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 ;(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 * Participants with diagnosis of Fanconi anemia, Kostmann syndrome, Shwachman diamond syndrome, or any other known bone marrow failure syndrome

Primary outcome measure(s)

Trial sites (32)

FacilityCityRegionStatus
The University of Alabama at Birmingham Birmingham Alabama
City of Hope Duarte California
Massachusetts General Hospital Boston Massachusetts
Albert Einstein College Of Medicine New York New York
Novant Health Charlotte North Carolina
Novant Health Forsyth Medical Center Winston-Salem North Carolina
MD Anderson Houston Texas
Monash Medical Centre Clayton Australia
Peter MacCallum Cancer Centre Melbourne Australia
Westmead Hospital Westmead Australia
Princess Margaret Cancer Centre University Health Network Toronto Ontario
Institut Paoli Calmettes Marseille France
Chu Rennes Hopital Pontchaillou Rennes France
Institut Universitaire du Cancer Toulouse Oncopole Toulouse France
CHU de Tours - Hôpital de Bretonneau Tours France
Charite Universitaetsmedizin Berlin Berlin Germany
Universitatsklinikum Carl Gustav Carus Dresden Dresden Germany
Universitaetsklinikum Heidelberg Heidelberg Germany
Universitaetsklinikum Leipzig Leipzig Germany
Universitatsklinikum Ulm Ulm Germany
Azienda Opedaliero-Universitaria Policlinico Sant'orsola Malpighi di Bologna Bologna Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori Meldola Italy
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
IRCCS Istituto Clinico Humanitas Rozzano Italy
Hosp Clinic de Barcelona Barcelona Spain
Hosp. de La Santa Creu I Sant Pau Barcelona Spain
Hosp Univ Vall D Hebron Barcelona Spain
Hosp Univ Fund Jimenez Diaz Madrid Spain
Clinica Univ. de Navarra Pamplona Spain
University College London Hospitals NHSFT London United Kingdom
Christie Hospital NHS Trust Manchester United Kingdom
Oxford University Hospitals NHS Trust Oxfordshire United Kingdom

More Janssen Research & Development, LLC trials in the UK

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05453903 on ClinicalTrials.gov ↗ ← All trials in the UK