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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06651229
Registration number
NCT06651229
Ethics application status
Date submitted
18/10/2024
Date registered
21/10/2024
Date last updated
22/06/2025
Titles & IDs
Public title
A Study of JNJ-90189892 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms
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Scientific title
A Phase 1, First-in-Human, Dose Escalation Study of JNJ-90189892 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms
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Secondary ID [1]
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90189892AML1001
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Secondary ID [2]
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90189892AML1001
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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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Myelodysplastic Neoplasms
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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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Blood
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Haematological diseases
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Blood
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Other blood disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - JNJ-90189892
Experimental: JNJ-90189892 - Participants will receive JNJ-90189892 in Part 1 (Dose escalation) of the study and the dose levels will be escalated sequentially based on the decisions of the study evaluation team (SET) until the recommended phase 2 dose (RP2D) has been identified. Participants in Part 2 (Dose expansion) will receive JNJ-90189892 at the RP2D determined in Part 1.
Treatment: Drugs: JNJ-90189892
JNJ-90189892 will be administered.
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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) by Severity
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Assessment method [1]
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An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. 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, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.
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Timepoint [1]
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From screening untill 30 days after last dose of study drug (that is approximately 2.5 years)
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Primary outcome [2]
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Part 1: Number of Participants with Dose-Limiting Toxicity (DLTs)
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Assessment method [2]
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DLT is defined as any toxicity that requires discontinuation of treatment, any Grade 5 toxicity; Non-hematologic toxicity (Grade 3 or 4) and Hematologic toxicity.
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Timepoint [2]
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At least 14 days
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Secondary outcome [1]
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Serum Concentration of JNJ-90189892
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Assessment method [1]
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Serum samples will be analyzed to determine concentrations of JNJ-90189892.
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Timepoint [1]
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Up to approximately 2.5 years
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Secondary outcome [2]
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Area Under the Curve Over a Dosing Interval (AUC tau) of JNJ-90189892
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Assessment method [2]
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AUC tau is the total observed plasma concentration of JNJ-90189892 in the body during the time between doses. AUCtau of JNJ-90189892 will be reported.
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Timepoint [2]
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Up to approximately 2.5 years
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Secondary outcome [3]
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Maximum Observed Plasma Concentration (Cmax) of JNJ-90189892
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Assessment method [3]
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Cmax is the maximum observed plasma concentration of JNJ-90189892. Cmax of JNJ-90189892 will be reported.
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Timepoint [3]
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Up to approximately 2.5 years
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Secondary outcome [4]
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Minimum Observed Plasma Concentration (Cmin) of JNJ-90189892
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Assessment method [4]
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Cmin is the minimum observed plasma concentration of JNJ-90189892. Cmin of JNJ-90189892 will be reported.
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Timepoint [4]
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Up to approximately 2.5 years
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Secondary outcome [5]
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Number of Participants with Presence of Anti-JNJ-90189892 Antibodies
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Assessment method [5]
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Participants with presence of anti-JNJ-90189892 antibodies will be reported.
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Timepoint [5]
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Up to approximately 2.5 years
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Secondary outcome [6]
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Complete Response (CR) in Acute Myeloid Leukemia (AML)
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Assessment method [6]
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CR is achieved when a participant has a best response of CR (including complete response with partial hematologic recovery \[CRh\] or complete response with incomplete hematologic recovery \[CRi\]) according to the European Leukemia Network (ENL) 2022 criteria.
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Timepoint [6]
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Up to approximately 2.5 years
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Secondary outcome [7]
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Overall Response (OR) in Myelodysplastic Neoplasms (MDS)
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Assessment method [7]
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OR is achieved when a participant with MDS has a CR (any type, that is CRh or complete response with limited count recovery \[CRL\]), partial response (PR), or hematologic improvement (HI) according to the International Working Group (IWG) 2023 criteria.
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Timepoint [7]
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Up to approximately 2.5 years
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Secondary outcome [8]
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Complete Response in MDS
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Assessment method [8]
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CR is achieved when a participant has a best response of CR (including CRh/CRL) according to the IWG 2023 criteria.
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Timepoint [8]
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Up to approximately 2.5 years
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Secondary outcome [9]
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Duration of Response (DOR)
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Assessment method [9]
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DOR is defined for responsders only, as time from date of initial documentation of a response to the first documented evidence of no reponse, disease progression, relapse, initation of a new systemic anti-cancer therapy (besides hematopoietic stem cell transplant \[HSCT\]), or death, whichever comes first.
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Timepoint [9]
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Up to approximately 2.5 years
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Secondary outcome [10]
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Time to Response (TTR)
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Assessment method [10]
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TTR is defined for responders, as the time from the first dose of study drug to first qualifying response.
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Timepoint [10]
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Up to approximately 2.5 years
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Secondary outcome [11]
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Number of Participants Achieving Transfusion Independence
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Assessment method [11]
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Transfusion independence is defined as the absence of red blood cell (RBC) and platelet transfusions for 8 weeks or longer after starting study treatment for participants with AML and 16 weeks or longer for participants with MDS.
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Timepoint [11]
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Up to approximately 2.5 years
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Eligibility
Key inclusion criteria
* Have a diagnosis, per the world health organization (WHO) 2022 criteria, of (a) Acute myeloid leukemia (AML) or (b) Moderate high, high, or very high-risk myelodysplastic neoplasms (MDS) per Molecular International Prognostic Scoring System (IPSS-M)
* Body weight that is greater than or equals to (>=) 40 kg
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
* Have adequate renal function defined as Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Estimated Glomerular Filtration Rate (eGFR) >=40 milligrams per minute (mL/min) computed with the calculator on the CKD-EPI website
* Participants must have laboratory parameters in the required range
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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
* Has a medical history of clinically significant pulmonary compromise, particularly the current need for supplemental oxygen use to maintain adequate oxygenation
* Has evidence of uncontrolled systemic viral, bacterial, or fungal infection. Antimicrobial prophylaxis is permitted
* Has known allergies, hypersensitivity, or intolerance to JNJ-90189892 or its excipients
* Had major surgery or had significant traumatic injury within 14 days of planned first dose of JNJ-90189892
* Had a prior or concurrent second malignancy with natural history or treatment likely to interfere with any study endpoints of safety or the efficacy of the study treatment
* Has known active central nervous system involvement
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Not applicable
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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
21/03/2025
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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
1/12/2028
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Actual
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Sample size
Target
100
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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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Concord Hospital - Concord
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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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Sir Charles Gairdner Hospital - Nedlands
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Recruitment postcode(s) [1]
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2139 - Concord
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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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6009 - Nedlands
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Recruitment outside Australia
Country [1]
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Spain
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State/province [1]
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Madrid
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Country [2]
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Spain
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State/province [2]
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Pamplona
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Country [3]
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Spain
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State/province [3]
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Sevilla
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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 Part 1 (Dose Escalation) of the study is to assess the effective dose (recommended Phase 2 dose\[s\] \[RP2Ds\]) that can be safely administered, and dosing regimens of JNJ-90189892 in participants with relapsed or refractory (R/R) acute myeloid leukemia (AML) or R/R higher-risk type of myelodysplastic neoplasms (type of cancer of the blood and bone marrow, which does not respond to treatment or comes back after treatment). The purpose of Part 2 (Cohort Expansion) is to further assess the safety, tolerability and efficacy in participants with R/R AML or higher-risk types of MDS.
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Trial website
https://clinicaltrials.gov/study/NCT06651229
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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
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Study Contact
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Address
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Country
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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
Data sharing statement
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/NCT06651229
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