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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06852222




Registration number
NCT06852222
Ethics application status
Date submitted
25/02/2025
Date registered
28/02/2025
Date last updated
12/09/2025

Titles & IDs
Public title
A Study of Bleximenib, Venetoclax and Azacitidine For Treatment of Participants With Acute Myeloid Leukemia (AML)
Scientific title
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
Secondary ID [1] 0 0
75276617AML3001
Secondary ID [2] 0 0
75276617AML3001
Universal Trial Number (UTN)
Trial acronym
cAMeLot-2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Leukemia, Myeloid, Acute 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 intervention(s) / exposure
Treatment: Drugs - Bleximenib
Treatment: Drugs - Venetoclax (VEN)
Treatment: Drugs - Azacitidine (AZA)
Treatment: Drugs - Placebo

Experimental: Arm A: Bleximenib and Venetoclax (VEN) + Azacitidine (AZA) - Participants with acute myeloid leukemia (AML) will receive bleximenib in combination with venetoclax (VEN) and azacitidine (AZA) for 28-days treatment cycles and treatment will continue until progression or unacceptable toxicity.

Placebo comparator: Arm B: Placebo and Venetoclax (VEN) + Azacitidine (AZA) - Participants with AML will receive placebo in combination with VEN and AZA for 28-days treatment cycles, and treatment will continue until progression or unacceptable toxicity.


Treatment: Drugs: Bleximenib
Bleximenib will be administered orally.

Treatment: Drugs: Venetoclax (VEN)
VEN will be administered orally.

Treatment: Drugs: Azacitidine (AZA)
AZA will be administered intravenously or subcutaneously.

Treatment: Drugs: Placebo
Placebo will be administered orally.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants who Achieve Complete Remission (CR)
Timepoint [1] 0 0
Up to 4 years and 1 month
Primary outcome [2] 0 0
Overall Survival (OS)
Timepoint [2] 0 0
Up to 4 years and 1 month
Secondary outcome [1] 0 0
Event-free survival (EFS)
Timepoint [1] 0 0
Up to 4 years and 1 month
Secondary outcome [2] 0 0
Duration of CR
Timepoint [2] 0 0
Up to 4 years and 1 month
Secondary outcome [3] 0 0
Time to CR
Timepoint [3] 0 0
Up to 4 years and 1 month
Secondary outcome [4] 0 0
Rate of CR-Measurable Residual Disease (MRD)
Timepoint [4] 0 0
Up to 4 years and 1 month
Secondary outcome [5] 0 0
Percentage of Participants who Achieved Transfusion Independence
Timepoint [5] 0 0
Up to 4 years and 1 month
Secondary outcome [6] 0 0
Percentage of Participants with Allogeneic Hematopoietic Stem Cell Transplant (Allo-HSCT)
Timepoint [6] 0 0
Up to 4 years and 1 month
Secondary outcome [7] 0 0
Number of Participants with Adverse Events (AEs)
Timepoint [7] 0 0
Up to 4 years and 1 month
Secondary outcome [8] 0 0
Number of Participants with Abnormalities in Clinical Laboratory Parameters
Timepoint [8] 0 0
Up to 4 years and 1 month
Secondary outcome [9] 0 0
Serum Concentration of Bleximenib
Timepoint [9] 0 0
Up to 4 years and 1 month

Eligibility
Key inclusion 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) 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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 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
4/06/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/08/2029
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [2] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [3] 0 0
St Vincents Hospital Melbourne - Fitzroy
Recruitment hospital [4] 0 0
St George Hospital - Kogarah
Recruitment hospital [5] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [6] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 0 0
5042 - Bedford Park
Recruitment postcode(s) [2] 0 0
2050 - Camperdown
Recruitment postcode(s) [3] 0 0
3065 - Fitzroy
Recruitment postcode(s) [4] 0 0
2217 - Kogarah
Recruitment postcode(s) [5] 0 0
3000 - Melbourne
Recruitment postcode(s) [6] 0 0
4102 - Woolloongabba
Recruitment outside Australia
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United States of America
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Arkansas
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Florida
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Missouri
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New York
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North Carolina
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Ohio
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Oregon
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Pennsylvania
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Tennessee
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Texas
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Washington
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Belgium
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Bruges
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Belgium
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Edegem
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Belgium
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Genk
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Ghent
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La Louvière
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Leuven
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Ottignies
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Roeselare
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Brazil
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Barretos
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Brazil
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São Paulo
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Ontario
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Beijing
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Shenyang
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Wuhan
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Czechia
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Brno
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Prague
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Aalborg
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Ramat Gan
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Bergamo
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Brescia
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Meldola
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Gyeonggi-do
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Seoul
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Pamplona
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Salamanca
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Seville
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Taipei
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Taoyuan District
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Ankara
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Antalya
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Istanbul
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Mersin
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Samsun
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United Kingdom
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Brighton
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Canterbury
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Edinburgh
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Liverpool
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Plymouth
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United Kingdom
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Worthing

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Study Contact
Address 0 0
Country 0 0
Phone 0 0
844-434-4210
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?
The data sharing policy of Johnson \& Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency


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/NCT06852222