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New treatment option for Acute Myeloid Leukemia
Official title Bleximenib in Combination With Standard Induction and Consolidation Therapy Followed by Maintenance for Treatment of Patients With Acute Myeloid Leukemia (AML)
ClinicalTrials.gov ID: NCT07223814
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 acute myeloid leukemia.
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 current standard of care treatment for adult patients with acute myeloid leukemia (AML) consists of chemotherapy and, if indicated, donor stem cell transplantation. Bleximenib blocks the interaction between a protein called menin and another protein called KMT2A in the leukemia cells.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
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
- ≥18 years of age (or the legal age of majority in the jurisdiction in which the study is taking place, whichever is greater) at the time of informed...
- New diagnosis of AML (≥10% blasts in BM or peripheral blood) with mutated NPM1 or with recurring rearrangements involving KMT2A according to ICC 2022...
- Considered eligible for intensive chemotherapy.
- WHO/ECOG performance status ≤2.
- Adequate renal and hepatic functions prior to randomization.
You likely can't join if
- Prior (chemo-)therapy for AML, including prior treatment with hypomethylating agents
- Known active leukemic involvement of the central nervous system (CNS).
- Recipient of solid organ transplant.
- Cardiac disease:
- Any of the following within 6 months of randomization: myocardial infarction, uncontrolled/unstable angina, congestive heart failure (NYHA Class III...
- QTc interval using Fridericia's formula (QTcF) ≥470 ms. Prolonged QTc interval associated with bundle branch block or pacemaking is permitted.
See the full eligibility criteria
- ≥18 years of age (or the legal age of majority in the jurisdiction in which the study is taking place, whichever is greater) at the time of informed consent.
- New diagnosis of AML (≥10% blasts in BM or peripheral blood) with mutated NPM1 or with recurring rearrangements involving KMT2A according to ICC 2022 criteria.
- Considered eligible for intensive chemotherapy.
- WHO/ECOG performance status ≤2.
- Adequate renal and hepatic functions prior to randomization.
- Prior (chemo-)therapy for AML, including prior treatment with hypomethylating agents
- Known active leukemic involvement of the central nervous system (CNS).
- Recipient of solid organ transplant.
- Cardiac disease:
- Any of the following within 6 months of randomization: myocardial infarction, uncontrolled/unstable angina, congestive heart failure (NYHA Class III or IV), uncontrolled or symptomatic arrhythmias, stroke, or transient...
- QTc interval using Fridericia's formula (QTcF) ≥470 ms. Prolonged QTc interval associated with bundle branch block or pacemaking is permitted.
- Left ventricular ejection fraction (LVEF) \<40% by ECHO or MUGA scan obtained within 28 days prior to the start of study treatment.
- Previously received cumulative dose of any combination of anthracyclines or anthracenediones of ≥500 mg/m2.
- Chronic respiratory disease requiring supplemental oxygen.
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
- Atlanta, Georgia, United States
- Kansas City, Kansas, United States
- Baltimore, Maryland, United States
- St Louis, Missouri, United States
- Cincinnati, Ohio, United States
- Adelaide, Australia
- Birtinya, Australia
- Brisbane, Australia
- Camperdown, Australia
- Melbourne, Australia
- Sydney, Australia
- Antwerp, Belgium
- Charleroi, Belgium
- Geel, Belgium
- Ghent, Belgium
- Jolimont, Belgium
- Liège, Belgium
- Yvoir, Belgium
- Oulu, Finland
+ 19 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 San Francisco, California, United States; Atlanta, Georgia, United States; Kansas City, Kansas, United States; Baltimore, Maryland, United States; St Louis, Missouri, United States; Cincinnati, Ohio, United States and 33 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.