A Study of JNJ-89853413 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms
NCT ID: NCT06618001
Last Updated: 2026-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
100 participants
INTERVENTIONAL
2025-01-14
2028-01-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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JNJ-89853413
Participants will receive JNJ-89853413 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-89853413 at the RP2D determined in Part 1.
JNJ-89853413
JNJ-89853413 will be administered.
Interventions
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JNJ-89853413
JNJ-89853413 will be administered.
Eligibility Criteria
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Inclusion Criteria
1. relapsed/refractory acute myeloid leukemia (AML)
2. relapsed/refractory moderate high, high, or very high risk myelodysplastic neoplasms (MDS) per Molecular International Prognostic Scoring System (IPSS-M)
* Body weight greater than or equals to (\>=) 40 kilograms (kg)
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 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)
* Participants must have laboratory parameters in the required range
Exclusion Criteria
* Has evidence of an uncontrolled systemic viral, bacterial, or fungal infection
* Has known allergies, hypersensitivity, or intolerance to the excipients of JNJ-89853413
* Had major surgery or had significant traumatic injury within 14 days of planned first dose of JNJ-89853413
* Has known active central nervous system involvement
18 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Arthur J E Child Comprehensive Cancer Centre
Calgary, Alberta, Canada
Vancouver General Hospital
Vancouver, British Columbia, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
Hosp Clinic de Barcelona
Barcelona, , Spain
Hosp Univ Fund Jimenez Diaz
Madrid, , Spain
Clinica Univ. de Navarra
Pamplona, , Spain
Addenbrookes Hospital
Cambridge, , United Kingdom
University College London Hospitals
London, , United Kingdom
The Christie NHS Foundation Trust Christie Hospital
Manchester, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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89853413AML1001
Identifier Type: OTHER
Identifier Source: secondary_id
2024-513199-16-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
89853413AML1001
Identifier Type: -
Identifier Source: org_study_id
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