Phase 1 Evaluation of JNJ-89853413 in Relapsed/Refractory Acute Myeloid Leukemia and Higher-risk Myelodysplastic Neoplasms

The primary objective of this study is to evaluate the safety and tolerability of **JNJ-89853413** in patients with **relapsed or refractory acute myeloid leukemia** or **relapsed or refractory higher-risk types of myelodysplastic neoplasms**. This is clinically relevant as these conditions often have limited treatment options and poor prognosis, necessitating the development of new therapeutic strategies. The study aims to determine the potential of JNJ-89853413 to provide a new treatment avenue for these challenging hematological malignancies.

The clinical trial involves a total of **80 participants** diagnosed with **Relapsed or Refractory Acute Myeloid Leukemia** or **Relapsed or Refractory Higher-risk Types of Myelodysplastic Neoplasms**. The study population includes both male and female subjects, with an age range that encompasses adults and older adults. Participants were selected without targeting any vulnerable populations. The trial does not specify any particular lifestyle considerations such as diet or physical activity. The sponsor has not provided detailed information regarding the main objective of the trial or specific inclusion criteria.

The clinical trial is a **Phase 1** study designed to evaluate the safety and efficacy of a new investigational treatment for patients with **relapsed or refractory acute myeloid leukemia** or higher-risk types of **myelodysplastic neoplasms**. The trial employs a randomized, double-blind, and controlled design to ensure the reliability and validity of the results. The estimated duration of the trial is from January 15, 2025, to July 15, 2027, allowing for comprehensive data collection and analysis over this period.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. This initial visit will involve a thorough medical evaluation, including laboratory tests and imaging studies, to confirm the diagnosis and ensure the absence of exclusion criteria. Following successful screening, participants will be randomly assigned to either the investigational treatment group or the control group, with neither the participants nor the investigators aware of the group assignments to maintain the double-blind nature of the study.

Throughout the trial, participants will attend regular follow-up visits at specified intervals to monitor their response to the treatment and to identify any adverse events. These visits will include clinical assessments, laboratory tests, and other relevant evaluations to ensure participant safety and to gather data on the treatment's efficacy. The end-of-study visit will mark the conclusion of the participant's involvement, during which final assessments will be conducted to evaluate the overall outcomes of the treatment.

The expected length of participant involvement in the trial is approximately two and a half years, contingent upon individual response and adherence to the study protocol. Conditions that may lead to early termination from the study include the occurrence of significant adverse events, withdrawal of consent, or failure to comply with study procedures. The trial is conducted in accordance with ethical guidelines and regulatory requirements to ensure the safety and well-being of all participants.

No specific information regarding the experimental medication, including its name, pharmaceutical form, dosage, route, and frequency of administration, is provided in the available data. Consequently, a detailed description of the experimental treatment cannot be formulated based on the current dataset.

Similarly, there is no information available about any non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatment, used in the study. Therefore, a description of these elements is not possible with the given data.

Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also absent from the provided data. As such, no further details can be included in this description.

The clinical trial is designed to assess efficacy through a structured evaluation process. The trial is categorized as a Phase 1 study, with an estimated recruitment start date of January 15, 2025, and an estimated end date of July 15, 2027. The efficacy assessment will be conducted using predefined parameters, although specific endpoints and methods for measuring efficacy are not detailed in the available data. The trial will follow a systematic approach to collect and analyze data, ensuring that the results are scientifically valid and reliable. The trial's duration and phase indicate an early-stage investigation, focusing on initial efficacy and safety assessments. The absence of specific endpoints suggests that the trial may be exploratory in nature, aiming to gather preliminary data to inform future studies.