A Phase 1b Study of Bleximenib in Combination With AML-Directed Therapies for Participants With Acute Myeloid Leukemia Harboring KMT2A or NPM1 Alterations

Status: Recruiting
Location: See all (32) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: f
View:

• 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

Locations
United States
Alabama
The University of Alabama at Birmingham
COMPLETED
Birmingham
California
City of Hope
RECRUITING
Duarte
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
North Carolina
Novant Health
RECRUITING
Charlotte
Novant Health Forsyth Medical Center
RECRUITING
Winston-salem
New York
Albert Einstein College Of Medicine
RECRUITING
New York
Texas
MD Anderson
RECRUITING
Houston
Other Locations
Australia
Monash Medical Centre
RECRUITING
Clayton
Peter MacCallum Cancer Centre
RECRUITING
Melbourne
Westmead Hospital
RECRUITING
Westmead
Canada
Princess Margaret Cancer Centre University Health Network
ACTIVE_NOT_RECRUITING
Toronto
France
Institut Paoli Calmettes
ACTIVE_NOT_RECRUITING
Marseille
Chu Rennes Hopital Pontchaillou
RECRUITING
Rennes
Institut Universitaire du Cancer Toulouse Oncopole
RECRUITING
Toulouse
CHU de Tours - Hôpital de Bretonneau
RECRUITING
Tours
Germany
Charite Universitaetsmedizin Berlin
ACTIVE_NOT_RECRUITING
Berlin
Universitatsklinikum Carl Gustav Carus Dresden
ACTIVE_NOT_RECRUITING
Dresden
Universitaetsklinikum Heidelberg
ACTIVE_NOT_RECRUITING
Heidelberg
Universitaetsklinikum Leipzig
COMPLETED
Leipzig
Universitatsklinikum Ulm
ACTIVE_NOT_RECRUITING
Ulm
Italy
Azienda Opedaliero-Universitaria Policlinico Sant'orsola Malpighi di Bologna
RECRUITING
Bologna
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
RECRUITING
Meldola
ASST Grande Ospedale Metropolitano Niguarda
RECRUITING
Milan
IRCCS Istituto Clinico Humanitas
RECRUITING
Rozzano
Spain
Hosp Clinic de Barcelona
RECRUITING
Barcelona
Hosp Univ Vall D Hebron
RECRUITING
Barcelona
Hosp. de La Santa Creu I Sant Pau
RECRUITING
Barcelona
Hosp Univ Fund Jimenez Diaz
RECRUITING
Madrid
Clinica Univ. de Navarra
RECRUITING
Pamplona
United Kingdom
University College London Hospitals NHSFT
RECRUITING
London
Christie Hospital NHS Trust
RECRUITING
Manchester
Oxford University Hospitals NHS Trust
ACTIVE_NOT_RECRUITING
Oxfordshire
Contact Information
Primary
Study Contact
Participate-In-This-Study1@its.jnj.com
844-434-4210
Time Frame
Start Date: 2022-10-04
Estimated Completion Date: 2027-03-19
Participants
Target number of participants: 200
Treatments
Experimental: Arm A: Relapsed/Refractory Setting
Participants with relapsed/refractory AML harboring NPM1, KMT2A, NUP98, or NUP214 alterations will receive bleximenib in combination with either venetoclax (VEN) (Cohort A1: bleximenib+VEN) or azacitidine (AZA) (Cohort A2: bleximenib +AZA) or VEN+AZA (Cohort A3: bleximenib+VEN+AZA) or VEN + AZA (Cohort A4: bleximenib + VEN + AZA) in adolescent participants aged greater than or equal to (\>=) 12 years and less than (\<) 18 years of age, to select the recommended phase 2 dose (RP2D) of bleximenib in combination with VEN, AZA or VEN+AZA (dose selection). In dose expansion portion of the study, participants will receive bleximenib in combination with AML directed therapies at the RP2D(s).
Experimental: Arm B: Newly Diagnosed Chemotherapy Ineligible Setting
Participants will receive bleximenib in combination with VEN+AZA as frontline chemo therapy for newly diagnosed AML participants harboring KMT2A, NPM1, NUP98, or NUP214 alterations who are \>=75 years of age or \>=18 years of age to \<75 years of age with comorbidities that preclude the use of intensive induction chemotherapy.
Experimental: Arm C: Newly Diagnosed Chemotherapy Eligible Setting
Participants will receive combination of bleximenib with cytarabine+daunorubicin or idarubicin chemotherapy as frontline treatment regimen for participants \>= 18 to \<75 years of age with AML harboring NPM1, KMT2A, NUP98, or NUP214 alterations and eligible for intensive chemotherapy.
Related Therapeutic Areas
Sponsors
Leads: Janssen Research & Development, LLC

This content was sourced from clinicaltrials.gov