RightFit
RecruitingPhase 3

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether adding bleximenib to venetoclax and azacitidine works better than adding a placebo (a treatment with no active drug). It is for adults with newly diagnosed acute myeloid leukemia (AML), a blood cancer, with certain NPM1 or KMT2A gene changes who cannot have intensive chemotherapy.

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 newly diagnosed Acute Myeloid Leukemia (AML) with a mutation in the NPM1 or KMT2A gene.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older.
  • Have untreated AML with a KMT2A gene rearrangement or NPM1 gene mutation, and at least 10% immature leukemia cells in the bone marrow.
  • Be unable to have intensive chemotherapy. People age 75 or older must meet the study’s activity-level limits and have a doctor’s approval. Younger adults must have a qualifying health problem or limits on daily activity.
  • Have liver and kidneys that work well enough for the study.
  • Women must not be pregnant, breastfeed, or plan pregnancy, and must use the required birth control during the study and for 6 months after the last treatment dose.
  • Men must use the required birth control during the study and for at least 90 days after the last treatment dose.
  • Sign a consent form showing that you understand the study and agree to take part.

Who can't join

  • Have acute promyelocytic leukemia (APL), a different type of leukemia.
  • Have known active leukemia in the brain or spinal cord.
  • Have received a solid organ transplant.
  • Have had certain heart or blood vessel problems within 6 months before assignment to a study group, such as a heart attack, uncontrolled chest pain, heart failure, certain irregular heartbeats, a blocked blood vessel to the brain, or a mini-stroke.
  • Have active infectious hepatitis, an infection that affects the liver.
  • Have received a live, weakened vaccine within 4 weeks before assignment to a study group.
  • Have a known allergy, sensitivity, or intolerance to ingredients in bleximenib, azacitidine, or venetoclax.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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) Moderate hepatic impairment vi) Comorbidity that, in the investigator's opinion, makes the participant unsuitable for intensive chemotherapy, which must be documented before enrollment as defined in the protocol. Ineligibility for intensive chemotherapy should be explicitly approved by a multidisciplinary team in countries in which this process is standard of care * 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 for at least 90 days 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, azacitidine, or venetoclax excipients

Study sites (59)

AL

AR

AZ

CA

CO

DE

FL

IL

KY

LA

MA

MD

MI

MO

NC

NH

NJ

NY

OH

OR

PA

TN

TX

UT

VA

WA