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NCT06852222 | NOT YET RECRUITING | Leukemia, Myeloid, Acute

A Study of Bleximenib, Venetoclax and Azacitidine For Treatment of Participants With Acute Myeloid Leukemia (AML)
Sponsor:

Janssen Research & Development, LLC

Brief Summary:

The purpose of this study is to assess how bleximenib and Venetoclax (VEN)+ Azacitidine (AZA) works as compared to placebo and VEN+AZA alone for the treatment of participants with Acute Myeloid Leukemia (AML).

Condition or disease

Leukemia, Myeloid, Acute

Intervention/treatment

Bleximenib

Venetoclax (VEN)

Azacitidine (AZA)

Placebo

Phase

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 600 participants
Masking : DOUBLE
Primary Purpose : TREATMENT
Official Title : A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Study of Bleximenib, Venetoclax and Azacitidine for the Treatment of Participants With Newly Diagnosed Acute Myeloid Leukemia Harboring KMT2A Rearrangements or NPM1 Mutations Who Are Ineligible for Intensive Chemotherapy
Actual Study Start Date : 2025-05-02
Estimated Primary Completion Date : 2029-06-22
Estimated Study Completion Date : 2029-08-15

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion criteria
  • * Be 18 years of age or older at the time of informed consent
  • * Previously untreated lysine N-methyltransferase 2A gene rearranged (KMT2Ar) or nucleophosmin 1 gene mutated (NPM1m) acute myeloid leukemia (AML) with greater than or equal to (\> or =) 10% bone marrow blasts per 2022 international Consensus Classification criteria
  • * Ineligible for intensive chemotherapy based on the following criteria: a) \>= 75 years of age and ineligible per physician's discretion, with Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, b) \>=18 to \<75 years of age with \>= 1 of the following comorbidities: i) ECOG performance status of 2, ii) Severe cardiac disorder, iii) Severe pulmonary disorder, iv) Renal impairment, v) Comorbidity that, in the investigator's opinion, makes the participant unsuitable for intensive chemotherapy, which must be documented and approved by the sponsor before enrollment defined in the protocol
  • * Participants must have adequate hepatic and renal function
  • * A female participant must agree not to be pregnant, breast-feed, plan to become pregnant and use protocol-specified contraception while enrolled in this study and for 6 months after the last dose of study treatment
  • * A male participant must agree to use protocol-specified contraception while enrolled in this study and for 6 months after the last dose of study treatment
  • * Must sign an informed consent form indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study
  • Exclusion criteria
    • * Diagnosis of acute promyelocytic leukemia (APL)
    • * Known active leukemic involvement of the central nervous system (CNS)
    • * Recipient of solid organ transplant
    • * Any cardiac disorders such as heart attack, uncontrolled/unstable chest pain, congestive heart failure, uncontrolled or symptomatic irregular heartbeat, blockage of a blood vessel to brain, or transient ischemic (decreased oxygen in tissue) attack within 6 months of randomization
    • * Active infectious hepatitis
    • * Live, attenuated vaccine within 4 weeks of randomization
    • * Known allergies, hypersensitivity, or intolerance of bleximenib excipients
A Study of Bleximenib, Venetoclax and Azacitidine For Treatment of Participants With Acute Myeloid Leukemia (AML)

Location Details

NCT06852222

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

Denmark,

Aarhus University Hospital

Aarhus, Denmark, 8200

Not yet recruiting

Denmark,

Rigshospitalet

Copenhagen, Denmark, DK 2100