NCT06618001 A Study of JNJ-89853413 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms
| NCT ID | NCT06618001 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Janssen Research & Development, LLC |
| Condition | Leukemia, Myeloid, Acute |
| Study Type | INTERVENTIONAL |
| Enrollment | 115 participants |
| Start Date | 2025-01-14 |
| Primary Completion | 2027-07-15 |
Trial Parameters
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Brief Summary
The purpose of Part 1 (Dose Escalation) of the study is to assess the safety and tolerability, and to identify the recommended Phase 2 dose\[s\] (RP2D\[s\]) in participants with relapsed or refractory (R/R) acute myeloid leukemia (AML) (that is a type of blood cancer that has come back after treatment/or has stopped responding to treatment) or R/R higher-risk type of myelodysplastic neoplasms (MDS, type of blood cancer). 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.
Eligibility Criteria
Inclusion Criteria: * Have a diagnosis, per World Health Organization (WHO) 2022 criteria of: 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 a medical history of clinically significant pulmonary compromise, particularly the need for current supplemental oxygen use to maintain adequate oxygenation * Has evidence of an uncontrolled systemic viral, bacterial, or fungal infection * Has known allergies, hypersensitivi
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