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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05453903
Registration number
NCT05453903
Ethics application status
Date submitted
8/07/2022
Date registered
12/07/2022
Date last updated
23/05/2024
Titles & IDs
Public title
A Study of JNJ-75276617 in Combination With Acute Myeloid Leukemia (AML) Directed Therapies
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Scientific title
A Phase 1b Study of JNJ-75276617 in Combination With AML-Directed Therapies for Participants With Acute Myeloid Leukemia Harboring KMT2A or NPM1 Alterations
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Secondary ID [1]
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2021-003999-14
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Secondary ID [2]
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CR109124
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Leukemia, Myeloid, Acute
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Condition category
Condition code
Cancer
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Leukaemia - Acute leukaemia
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Cancer
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Leukaemia - Chronic leukaemia
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Cancer
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Children's - Leukaemia & Lymphoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - JNJ-75276617
Treatment: Drugs - Venetoclax (VEN)
Treatment: Drugs - Azacitidine (AZA)
Treatment: Drugs - Cytarabine
Treatment: Drugs - Daunorubicin or Idarubicin
Experimental: Arm A: Relapsed/Refractory Setting - Participants with relapsed/refractory AML harboring either NPM1 or KMT2A alterations will receive JNJ-75276617 in combination with either venetoclax (VEN) (Cohort A1: JNJ75276617+VEN) or azacitidine (AZA) (Cohort A2: JNJ-75276617+AZA) or VEN+AZA (Cohort A3: JNJ-75276617+VEN+AZA) to select the recommended phase 2 dose (RP2D) of JNJ-75276617 in combination with VEN, AZA or VEN+AZA (dose selection). In dose expansion portion of the study, participants will receive JNJ-75276617 in combination with AML directed therapies at the RP2D(s).
Experimental: Arm B: Newly Diagnosed Chemotherapy Ineligible Setting - Participants will receive JNJ-75276617 in combination with VEN+AZA as frontline chemo therapy for newly diagnosed AML participants harboring either KMT2A or NPM1 alterations who are greater than or equal to (>=)18 years of age to less than (<) 75 years of age with comorbidities that preclude the use of intensive induction chemotherapy.
Experimental: Arm C: Newly Diagnosed Chemotherapy Eligible Setting - Participants will receive combination of JNJ-75276617 with cytarabine+daunorubicin or idarubicin chemotherapy as frontline treatment regimen for participants >=18 to <75 years of age with AML harboring either NPM1 or KMT2A alterations and eligible for intensive chemotherapy.
Treatment: Drugs: JNJ-75276617
Participants will receive JNJ-75276617.
Treatment: Drugs: Venetoclax (VEN)
Participants will receive VEN.
Treatment: Drugs: Azacitidine (AZA)
Participants will receive AZA.
Treatment: Drugs: Cytarabine
Participants will receive cytarabine
Treatment: Drugs: Daunorubicin or Idarubicin
Participants will receive daunorubicin or idarubicin
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants with Adverse Events (AEs)
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Assessment method [1]
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An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
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Timepoint [1]
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Up to 3 Years 3 months
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Primary outcome [2]
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Number of Participants with Adverse Events (AEs) by Severity
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Assessment method [2]
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Number of Participants with AEs by severity will be reported. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.
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Timepoint [2]
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Up to 3 Years 3 months
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Primary outcome [3]
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Number of Participants with Dose-limiting Toxicity (DLT)
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Assessment method [3]
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Number of participants with DLT will be reported. The DLTs are specific adverse events and are defined per protocol as any of the following: non-hematologic toxicity, or hematologic toxicity.
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Timepoint [3]
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End of Cycle 1 (28 days)
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Secondary outcome [1]
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Plasma Concentration of JNJ- 75276617
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Assessment method [1]
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Plasma samples will be analyzed to determine concentrations of JNJ-75276617 using a validated, specific, and sensitive method.
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Timepoint [1]
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Up to 3 Years 3 months
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Secondary outcome [2]
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Number of Participants with Depletion of Leukemic Blasts
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Assessment method [2]
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Number of participants with depletion of leukemic blasts will be reported.
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Timepoint [2]
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Up to 3 Years 3 months
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Secondary outcome [3]
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Number of Participants with Differentiation of Leukemic Blasts
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Assessment method [3]
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Number of participants with differentiation of leukemic blasts will be reported.
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Timepoint [3]
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Up to 3 Years 3 months
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Secondary outcome [4]
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Changes in Expression of Menin-histone-lysine N-methyltransferase 2A (KMT2A) Target Genes
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Assessment method [4]
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Changes in expression of menin-KMT2A target genes will be reported.
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Timepoint [4]
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Up to 3 Years 3 months
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Secondary outcome [5]
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Percentage of Participants who Achieve Complete Remission (CR)
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Assessment method [5]
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Percentage of participants who achieve complete Remission (CR) will be reported. CR is defined as Bone marrow blasts less than (<) 5 percent (%); Absence of circulating blasts and blasts with Auer rods; Absence of extramedullary disease; Absolute neutrophil count (ANC) greater than or equal to (>=) 1.0 x 109/Liter (1,000/microliter [µL] ); Platelet count >= 100 x 109/L (100,000/µL).
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Timepoint [5]
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Up to 3 Years 3 months
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Secondary outcome [6]
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Percentage of Participants who Achieve Complete Remission with Partial Hematologic Recovery (CRh)
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Assessment method [6]
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Percentage of participants who achieve complete remission with partial hematologic recovery (CRh) will be reported. CRh is defined as All criteria of CR with both ANC >0.5 x 109/L (500/µL) and platelet count >50 x 109/L (50,000/µL).
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Timepoint [6]
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Up to 3 Years 3 months
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Secondary outcome [7]
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Percentage of Participants who Achieve Complete Remission with Incomplete Hematologic Recovery (CRi)
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Assessment method [7]
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Percentage of participants who achieve complete remission with incomplete hematologic recovery (CRi) will be reported. CRi is defined as All CR criteria except for residual neutropenia (<1.0 x 109/L [1,000/µL]) or thrombocytopenia (<100 x 109/L [100,000/µL]).
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Timepoint [7]
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Up to 3 Years 3 months
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Secondary outcome [8]
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Percentage of Participants who Achieved Overall Response
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Assessment method [8]
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Percentage of participants who achieve overall response will be reported. Overall response rate (ORR) is defined as the percentage of participants achieving CR, CRh, or CRi.
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Timepoint [8]
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Up to 3 Years 3 months
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Secondary outcome [9]
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Duration of response
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Assessment method [9]
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Duration of response is defined as time from achieving first response of CR, CRh, CRi or overall response to hematologic relapse or death of any cause.
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Timepoint [9]
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Up to 3 Years 3 months
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Secondary outcome [10]
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Time to Response
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Assessment method [10]
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Time to response is defined as time from first dose to achieving the first response of CR, CRh, CRi or overall response.
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Timepoint [10]
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Up to 3 Years 3 months
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Eligibility
Key inclusion criteria
- Diagnosis of AML according to World Health Organization (WHO) criteria: a) De novo or
secondary AML; b) relapsed /refractory (Arm A only); c) harboring NPM1 / KMT2A
alterations
- Pretreatment clinical laboratory values meeting the following criteria -listed below:
White blood cell (WBC) count: less than or equal to <=25 x 10^9 per liter (/L),
adequate liver and renal function
- ECOG performance status grade of 0, 1 or 2
- A woman of childbearing potential must have a negative highly sensitive serum
beta-human chorionic gonadotropin at screening and within 48 hours prior to the first
dose of study treatment
- Must sign an informed consent form (ICF) indicating participant understands the
purpose of the study and procedures required for the study and is willing to
participate in the study.
- Willing and able to adhere to the prohibitions and restrictions specified in this
protocol
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Acute promyelocytic leukemia according to WHO 2016 criteria
- Leukemic involvement of the central nervous system
- Recipient of solid organ transplant
- Cardiovascular disease that is uncontrolled, increases risk for Torsades de Pointes or
that was diagnosed within 6 months prior to the first dose of study treatment
including, but not limited to:(a) Myocardial infarction; (b) Severe or unstable
angina; (c) Clinically significant cardiac arrhythmias, including bradycardia (less
than [<] 50 beats per minute); (d) Uncontrolled (persistent) hypertension: (example,
blood pressure greater than [>] 140/90 millimeters of mercury [mm Hg]; (e) Acute
neurologic events such as stroke or transient ischemic attack, intracranial or
subarachnoid hemorrhage, intracranial trauma; (f) Venous thromboembolic events
(example, pulmonary embolism) within 1 month prior to the first dose of study
treatment (uncomplicated Grade less than or equal to [=]2 deep vein thrombosis is not
considered exclusionary);(g)Congestive heart failure (NYHA class III to IV); (h)
Pericarditis or clinically significant pericardial effusion; (i) Myocarditis; (j)
Endocarditis (k) Clinically significant hypokalemia, hypomagnesemia, hypocalcemia
(corrected for hypoalbuminemia)
- Any toxicity (except for alopecia, stable peripheral neuropathy, thrombocytopenia,
neutropenia, anemia) from previous anticancer therapy that has not resolved to
baseline or to grade 1 or less
- Pulmonary compromise that requires the need for supplemental oxygen use to maintain
adequate oxygenation
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
4/10/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
5/03/2026
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Actual
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Sample size
Target
150
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Monash Medical Centre - Clayton
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Recruitment hospital [2]
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Peter MacCallum Cancer Centre - Melbourne
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Recruitment hospital [3]
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Westmead Hospital - Westmead
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Recruitment postcode(s) [1]
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3168 - Clayton
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Recruitment postcode(s) [2]
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3000 - Melbourne
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Recruitment postcode(s) [3]
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2145 - Westmead
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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Country [2]
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United States of America
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State/province [2]
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California
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United States of America
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Massachusetts
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United States of America
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State/province [4]
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New York
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Country [5]
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United States of America
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State/province [5]
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North Carolina
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Country [6]
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United States of America
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State/province [6]
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Texas
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Country [7]
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France
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State/province [7]
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Marseille Cedex 9
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Country [8]
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France
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State/province [8]
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Toulouse Cedex 9
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Country [9]
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France
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State/province [9]
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Tours
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Country [10]
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Germany
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State/province [10]
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Berlin
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Germany
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State/province [11]
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Dresden
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Germany
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Heidelberg
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Germany
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Leipzig
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Germany
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State/province [14]
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Ulm
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Italy
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State/province [15]
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Bologna
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Italy
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Meldola
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Italy
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State/province [17]
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Milano
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Country [18]
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Italy
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State/province [18]
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Rozzano
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Country [19]
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Spain
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State/province [19]
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Barcelona
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Country [20]
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Spain
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Madrid
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Spain
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State/province [21]
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Pamplona
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United Kingdom
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State/province [22]
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London
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United Kingdom
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Manchester
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Country [24]
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United Kingdom
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State/province [24]
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Oxfordshire
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Janssen Research & Development, LLC
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to determine the recommended Phase 2 dose (RP2D) candidate(s) of
JNJ-75276617 in combination with AML directed therapies (dose selection) and further to
evaluate safety and tolerability of JNJ-75276617 in combination with AML directed therapies
at the RP2D(s) (dose expansion).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05453903
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Janssen Research & Development, LLC Clinical Trial
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Address
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Janssen Research & Development, LLC
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Study Contact
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Address
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Phone
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844-434-4210
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05453903
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