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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT05453903
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Leukemia, Myeloid, Acute

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bleximenib — DRUG
    Participants will receive bleximenib.
  • Venetoclax (VEN) — DRUG
    Participants will receive VEN.
  • Azacitidine (AZA) — DRUG
    Participants will receive AZA.
  • Cytarabine — DRUG
    Participants will receive cytarabine.
  • Daunorubicin or Idarubicin — DRUG
    Participants will receive daunorubicin or idarubicin.

Study Details

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).

Key Dates

Start date
Oct 4, 2022
Status verified
Jun 2026
Primary completion
Oct 30, 2026
Completion
Mar 3, 2027

Study Design

Enrollment
196 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Number of Participants with Adverse Events (AEs) [ Time Frame: Up to 3 Years 3 months ]

Locations (7)

FacilityCityStateZIPSite coordinators
The University of Alabama at BirminghamBirminghamAlabama35233-
City of HopeDuarteCalifornia91010-
Massachusetts General HospitalBostonMassachusetts02114-
Albert Einstein College Of MedicineNew YorkNew York10461-
Novant HealthCharlotteNorth Carolina28204-
Novant Health Forsyth Medical CenterWinston-SalemNorth Carolina27103-
MD AndersonHoustonTexas77030-

Find similar trials in Birmingham, AL

By research site
The University of Alabama at Birmingham· Birmingham, ALCity of Hope· Duarte, CAMassachusetts General Hospital· Boston, MAAlbert Einstein College Of Medicine· New York, NYNovant Health· Charlotte, NCNovant Health Forsyth Medical Center· Winston-Salem, NC

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