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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT07223814


Additional trial details provided through ANZCTR are available at the end of this record.


Registration number
Help: Registration number
NCT07223814
Ethics application status
Help: Ethics application status
Date submitted
Help: Date submitted
30/10/2025
Date registered
Help: Date registered
3/11/2025
Date last updated
Help: Date last updated
6/11/2026

Titles & IDs
Public title
Bleximenib in Combination With Standard Induction and Consolidation Therapy Followed by Maintenance for Treatment of Patients With Acute Myeloid Leukemia (AML)
Scientific title
Bleximenib or Placebo in Combination With Standard Induction and Consolidation Therapy Followed by Maintenance for the Treatment of Patients With Newly Diagnosed KMT2A-rearranged or NPM1-mutant Acute Myeloid Leukemia Eligible for Intensive Chemotherapy: a Double-blind Phase 3 Study
Additional trial identifiers [1] 0 0
2025-522767-15-00
Additional trial identifiers [2] 0 0
HOVON 181 AML
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Acute Myeloid Leukemia 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Treatment: Drugs - Bleximenib
Treatment: Drugs - Cytarabine
Treatment: Drugs - Daunorubicin or Idarubicin
Treatment: Drugs - Placebo

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)


Treatment: Drugs: Bleximenib
Participants will receive bleximenib

Treatment: Drugs: Cytarabine
Participants will receive Cytarabine

Treatment: Drugs: Daunorubicin or Idarubicin
Participants will receive Daunorubicin or Idarubicin

Treatment: Drugs: Placebo
Participants will receive Placebo
Intervention code [1] 0 0
Treatment: Drugs
Description of the comparator or control
Control group

Outcomes
Primary outcome [1] 0 0
Event-Free Survival (EFS) in adult patients with newly diagnosed NPM1m or KMT2Ar AML eligible for intensive chemotherapy
Timepoint [1] 0 0
Up to 4 years and 5 months
Secondary outcome [1] 0 0
Overall Survival (OS) in adult patients with newly diagnosed NPM1m or KMT2Ar AML eligible for intensive chemotherapy
Timepoint [1] 0 0
Up to 7 years and 10 months
Secondary outcome [2] 0 0
Rates of CR, CRh, CRi in adult patients with newly diagnosed NPM1m or KMT2Ar AML eligible for intensive chemotherapy
Timepoint [2] 0 0
Up to 7 years and 10 months
Secondary outcome [3] 0 0
Prolongation of CR (DoCR) in adult patients with newly diagnosed NPM1m or KMT2Ar AML eligible for intensive chemotherapy
Timepoint [3] 0 0
Up to 4 years and 5 months
Secondary outcome [4] 0 0
Percentage of participants undergoing an allo-SCT in adult patients with newly diagnosed NPM1m or KMT2Ar AML eligible for intensive chemotherapy
Timepoint [4] 0 0
Up to 7 years and 10 months

Eligibility
Key inclusion criteria
1. =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.
2. 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.
3. Considered eligible for intensive chemotherapy.
4. WHO/ECOG performance status =2.
5. Adequate renal and hepatic functions prior to randomization.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
1. Prior (chemo-)therapy for AML, including prior treatment with hypomethylating agents
2. Known active leukemic involvement of the central nervous system (CNS).
3. Recipient of solid organ transplant.
4. Cardiac disease:

1. 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 ischemic attack.
2. QTc interval using Fridericia's formula (QTcF) =470 ms. Prolonged QTc interval associated with bundle branch block or pacemaking is permitted.
3. Left ventricular ejection fraction (LVEF) <40% by ECHO or MUGA scan obtained within 28 days prior to the start of study treatment.
4. Previously received cumulative dose of any combination of anthracyclines or anthracenediones of =500 mg/m2.
5. Chronic respiratory disease requiring supplemental oxygen.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2026
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2033
Actual
Sample size
Target
875
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
AU-Adelaide-FLINDERS - Adelaide
Recruitment hospital [2] 0 0
AU-Adelaide-RAH - Adelaide
Recruitment hospital [3] 0 0
AU-Birtinya-SUNSHINECOAST - Birtinya
Recruitment hospital [4] 0 0
AU-Brisbane-PAH - Brisbane
Recruitment hospital [5] 0 0
AU-Brisbane-RBWH - Brisbane
Recruitment hospital [6] 0 0
AU-Camperdown-RPA - Camperdown
Recruitment hospital [7] 0 0
AU-Melbourne-AUSTIN - Melbourne
Recruitment hospital [8] 0 0
AU-Melbourne-MONASH - Melbourne
Recruitment hospital [9] 0 0
AU-Melbourne-PMCC - Melbourne
Recruitment hospital [10] 0 0
AU-Sydney-RNSH - Sydney
Recruitment hospital [11] 0 0
AU-Sydney-WSAH - Sydney
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Birtinya
Recruitment postcode(s) [3] 0 0
- Brisbane
Recruitment postcode(s) [4] 0 0
- Camperdown
Recruitment postcode(s) [5] 0 0
- Melbourne
Recruitment postcode(s) [6] 0 0
- Sydney
Recruitment outside Australia
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California
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Florida
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Missouri
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North Carolina
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Ohio
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Pennsylvania
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Austria
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Feldkirch
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Austria
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Linz
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Belgium
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Antwerp
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Bruges
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Brussels
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Charleroi
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Geel
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Ghent
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Hasselt
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Jolimont
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Leuven
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Liège
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Yvoir
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Estonia
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Tallinn
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Tartu
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Finland
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Helsinki
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Kuopio
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Oulu
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Tampere
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Finland
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Turku
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Germany
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Aachen
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Bochum
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Bonn
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Braunschweig
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Greifswald
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Halle
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Homburg
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Mainz
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Oldenburg
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Passau
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Rostock
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Ulm
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Chuoku
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Tokushima
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Yamagata
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Yoshida
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Netherlands
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's-Hertogenbosch
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Amersfoort
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Amsterdam
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Arnhem
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Breda
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Dordrecht
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Eindhoven
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Groningen
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Leeuwarden
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Leiden
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Maastricht
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Nieuwegein
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Nijmegen
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Rotterdam
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The Hague
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Utrecht
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Zwolle
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Bergen
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Oslo
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Stavanger
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Tromsø
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Trondheim
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Spain
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Barcelona
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Lleida
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Spain
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Palma de Mallorca
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Sweden
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Lund
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Switzerland
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Basel
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Switzerland
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Bern
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Switzerland
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Fribourg
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Switzerland
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Geneva
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Switzerland
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Sankt Gallen
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Switzerland
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Zurich

Funding & Sponsors
Primary sponsor type
Other
Name
Stichting Hemato-Oncologie voor Volwassenen Nederland
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
German-Austrian Acute Myeloid Leukemia Study Group
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
M.H.G.P. Raaijmakers
Address 0 0
Erasmus Medical Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
M.H.G.P. Raaijmakers
Address 0 0
Country 0 0
Phone 0 0
010 7033740
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
According to the current publication policy the protocol and Statistica! Analysis Plan ( SAP) will be shared. The principal lnvestigators can be contacted for IPD sharing after the publication of the study results. According to 'HOVON sample and/or Data request Form' theHOVON director; chair of theHOVON Acute Myeloid Leukemie working group, the study PI and Coordinating lnvestigator should approve data/sample sharing.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
After the publication of primary endpoint analysis
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT07223814

Additional trial details provided through ANZCTR
Sponsors and collaborators
Primary sponsor
Other Collaborative groups
Primary sponsor name
Australasian Leukaemia and Lymphoma Group
Primary sponsor country
Australia

Secondary sponsor category [1] 138
Other Collaborative groups
Name [1] 138
HOVON
Country [1] 138
Netherlands

No Other Collaborator Provided
Funders
No Funding Source Provided
Ethics
Ethics application status
Submitted, not yet approved

No Ethics Committee Provided
Anticipated or final sample size
Australia
New Zealand
Accrual to date
45
Recruitment sites
Australian sites
Recruitment state(s)
NSW,QLD,SA,WA,VIC

No Recruitment Hospital Provided

No Recruitment Postcode Provided
New Zealand sites
Province(s)/district(s)
Auckland
 
Notes
Public notes

Contacts
Principal investigator
Title 549 0
Prof
Name 549 0
Andrew Wei
Address 549 0
Peter MacCallum Cancer Centre 305 Grattan St, Melbourne, Victoria 3000
Country 549 0
Australia
Phone 549 0
+61 3 9345 2555
Email 549 0
[email protected]
Contact person for public queries
Name 550 0
Delaine Smith
Address 550 0
Australasian Leukaemia & Lymphoma Group. 35 Elizabeth St Richmond Vic 3121
Country 550 0
Australia
Phone 550 0
+61 03 83739701
Email 550 0
[email protected]
Contact person for scientific queries
Name 551 0
Delaine Smith
Address 551 0
Australasian Leukaemia & Lymphoma Group. 35 Elizabeth St Richmond Vic 3121
Country 551 0
Australia
Phone 551 0
+61 03 83739701
Email 551 0
[email protected]
Data sharing
Does IPD data sharing statement differ?
No
What supporting documents are/will be available?

No Supporting Document Provided