A Study of Bleximenib in Combination With Acute Myeloid Leukemia (AML) Directed Therapies
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Primary outcome measure(s)
- Number of Participants with Adverse Events (AEs) — Up to 3 Years 3 months
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. - Number of Participants with Adverse Events (AEs) by Severity — Up to 3 Years 3 months
Number of Participants with AEs by severity will be reported. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event. - Number of Participants with Dose-limiting Toxicity (DLT) — End of Cycle 1 (28 days)
Number of participants with DLT will be reported according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
Trial sites (32)
| Facility | City | Region | Status |
|---|---|---|---|
| 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
Other trials for the same condition
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