A Study of JNJ-90189892 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms

Launched by JANSSEN RESEARCH & DEVELOPMENT, LLC · Oct 18, 2024

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ClinConnect Summary

This clinical trial is testing a new treatment called JNJ-90189892 for people with relapsed or refractory acute myeloid leukemia (AML) or certain types of myelodysplastic neoplasms (MDS), which are cancers affecting the blood and bone marrow that either do not respond to treatment or come back after treatment. The study has two parts: the first part focuses on finding the right dose of the drug that is safe for patients, while the second part looks at how well the drug works and how well patients tolerate it.

To participate in this trial, individuals must be diagnosed with AML or high-risk MDS and weigh at least 40 kg. Other important criteria include having a good performance status (meaning they are generally able to carry out daily activities) and normal kidney function. Participants will be closely monitored throughout the study to ensure their safety and to gather information about how the treatment works. It's also important to know that those with certain medical conditions, such as severe lung problems or active infections, may not be eligible for this trial. Overall, this study is an important step toward finding better treatments for these challenging blood cancers.

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Eligibility criteria

• 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
• 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