Bleximenib in Combination With Standard Induction and Consolidation Therapy Followed by Maintenance for Treatment of Patients With Acute Myeloid Leukemia (AML)

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
Stichting Hemato-Oncologie voor Volwassenen Nederland
Study ID
NCT07223814
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Bleximenib — DRUG
    Participants will receive bleximenib
  • Cytarabine — DRUG
    Participants will receive Cytarabine
  • Daunorubicin or Idarubicin — DRUG
    Participants will receive Daunorubicin or Idarubicin
  • Placebo — DRUG
    Participants will receive Placebo

Study Details

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. When this interaction is disrupted in AML with mutations in the NPM1 or KMT2A gene, bleximenib can cause leukemia cells to die. The main objective is to assess if treatment with bleximenib, when added to chemotherapy treatment will improve treatment outcome in adult participants with newly diagnosed AML who present with mutations in the NPM1 or KMT2A genes. This is a randomized, double-blind, placebo-controlled, phase 3 clinical trial. All of the participants will receive standard chemotherapy treatment, combined with either bleximenib or a placebo. A placebo is a substance that looks like the study medicine but has no active ingredients (e.g., a sugar pill). In a double blind trial neither the participant nor the doctor know if placebo or active study drug is given. After the end of the protocol treatment there will be an observational follow-up of 4 years from the time of inclusion of the last patient. The results of the different treatment groups will be compared. 875 previously untreated patients with AML with a specific change in the DNA of the leukemia cells (a KMT2A rearrangement or a NPM1 mutation) will be included. Participants must be 18 years or older and considered eligible for intensive chemotherapy.

Key Dates

Start date
Mar 1, 2026
Status verified
Mar 2026
Primary completion
Jun 30, 2030
Completion
Dec 31, 2033

Study Design

Enrollment
875 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: Standard of care treatment plus bleximenib and also maintenance treatment with bleximenib
    Bleximenib in combination with remission induction and consolidation therapy, followed by bleximenib maintenance therapy. Treatment will continue until PD, unacceptable toxicity or other protocol defined criteria for discontinuation (whichever comes first)
  • Experimental: Arm 2: Standard of care treatment plus bleximenib and maintenance treatment with a placebo.
    Bleximenib in combination with remission induction and consolidation therapy, followed by placebo maintenance therapy. Treatment will continue until PD, unacceptable toxicity or other protocol defined criteria for discontinuation (whichever comes first)
  • Placebo Comparator: Arm 3: Standard of care treatment plus a placebo and maintenance treatment with a placebo.
    Placebo comparator in combination with remission induction and consolidation therapy, followed by placebo maintenance therapy . Treatment will continue until PD, unacceptable toxicity or other protocol defined criteria for discontinuation (whichever comes first)

Primary Outcome Measure

Event-Free Survival (EFS) in adult patients with newly diagnosed NPM1m or KMT2Ar AML eligible for intensive chemotherapy [ Time Frame: Up to 4 years and 5 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
US-Cincinnati OH-CINCYCincinnatiOhio45219
E. Curran

Find similar trials in Cincinnati, OH

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
US-Cincinnati OH-CINCY· Cincinnati, OH

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