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New treatment option for Leukemia, Myeloid, Acute
Official title A Study of Bleximenib, Venetoclax and Azacitidine For Treatment of Participants With Newly Diagnosed Acute Myeloid Leukemia (AML)
ClinicalTrials.gov ID: NCT06852222
What this study is testing
What is Bleximenib?
Bleximenib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for leukemia, myeloid, acute.
Also referred to as JNJ-75276617.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Ineligible for intensive chemotherapy based on the following criteria: a) \>= 75 years of age and ineligible per physician's discretion, with Eastern...
- 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...
You likely can't join if
- 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...
- Active infectious hepatitis
- Live, attenuated vaccine within 4 weeks of randomization
See the full eligibility 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...
- 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...
- 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
- 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...
- Active infectious hepatitis
- Live, attenuated vaccine within 4 weeks of randomization
- Known allergies, hypersensitivity, or intolerance of bleximenib, azacitidine, or venetoclax excipients
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Goodyear, Arizona, United States
- Tucson, Arizona, United States
- Little Rock, Arkansas, United States
- Duarte, California, United States
- Aurora, Colorado, United States
- Newark, Delaware, United States
- Fort Myers, Florida, United States
- Jupiter, Florida, United States
- Orlando, Florida, United States
- Pembroke Pines, Florida, United States
- Tampa, Florida, United States
- Weston, Florida, United States
- Chicago, Illinois, United States
- Niles, Illinois, United States
- Lexington, Kentucky, United States
- Louisville, Kentucky, United States
- Baton Rouge, Louisiana, United States
- Boston, Massachusetts, United States
- Detroit, Michigan, United States
+ 196 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Goodyear, Arizona, United States; Tucson, Arizona, United States; Little Rock, Arkansas, United States; Duarte, California, United States; Aurora, Colorado, United States and 210 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.