Phase 1 Multicenter Dose-Escalation Study of Daratumumab with Idarubicin and Cytarabine or CPX-351 in Patients Aged 60+ with Adverse Risk Acute Myeloblastic Leukemia

The primary objective of this multicentric Phase 1 study is to evaluate the safety and tolerability of **daratumumab** in combination with chemotherapy regimens, specifically idarubicin and cytarabine, or CPX-351, in adult patients aged 60 years or older with adverse risk **Acute Myeloblastic Leukemia (AML)**. This study aims to determine the appropriate dosage levels of daratumumab when used in conjunction with these chemotherapy agents, which is clinically relevant for optimizing treatment protocols and improving patient outcomes in this high-risk population.

The clinical trial involves **adult patients** diagnosed with **adverse Risk Acute Myeloblastic Leukemia**. The study population includes both male and female participants, with an age range that encompasses young adults to middle-aged individuals. The trial population was selected to include a vulnerable population, although specific lifestyle considerations such as diet, physical activity, or habits are not detailed. The sponsor has not provided information regarding the total number of participants in the study. Key inclusion or exclusion criteria are not specified in the available data.

This clinical trial is a **Phase 3** study designed to evaluate the safety and efficacy of **daratumumab** in combination with chemotherapy agents **idarubicin** and **cytarabine**, or **CPX-351**, in adult patients aged 60 years or older diagnosed with adverse risk **Acute Myeloblastic Leukemia (AML)**. The trial is structured as a multicentric, randomized, double-blind, controlled study, ensuring that neither the participants nor the investigators know which treatment the participants are receiving, thereby minimizing bias. The estimated recruitment start date is January 14, 2025, with an anticipated end date of July 14, 2028, making the overall trial duration approximately three and a half years.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. This visit will involve a comprehensive evaluation, including medical history, physical examination, and laboratory tests. Following successful screening, participants will be randomized into treatment groups and will attend regular follow-up visits to monitor their response to the treatment and any potential adverse effects. These visits will include clinical assessments, laboratory evaluations, and imaging studies as necessary. The end-of-study visit will occur after the completion of the treatment period, where final assessments will be conducted to evaluate the overall outcomes and safety of the treatment regimen.

The expected length of participant involvement in the study is contingent upon the treatment regimen and individual response, with the possibility of early termination if specific conditions arise. These conditions may include significant adverse reactions, disease progression, or withdrawal of consent by the participant. The study is designed to adhere to rigorous ethical standards and regulatory requirements, ensuring the safety and well-being of all participants throughout the trial duration.

In this clinical trial, the experimental medication and non-experimental treatments have not been specified in the provided data. Therefore, a detailed description of the experimental medication, including its name, pharmaceutical form, dosage, route, and frequency of administration, cannot be provided. Similarly, information regarding any non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatment, is not available.

Due to the lack of specific data, additional relevant information about drug administration, dosing schedules, and participant compliance monitoring cannot be detailed. The absence of this information precludes the provision of a comprehensive description of the treatments used in this clinical trial.

The clinical trial is designed to assess efficacy in a Phase 3 study. The trial is scheduled to commence recruitment on January 14, 2025, with an estimated completion date of July 14, 2028. The efficacy assessment will be conducted through a series of planned evaluations, although specific parameters or endpoints for efficacy evaluation are not detailed in the available data. The trial will follow a structured timeline to ensure systematic data collection and analysis, adhering to the rigorous standards expected in a Phase 3 clinical trial. The study will employ validated methodologies appropriate for the trial phase to ensure the reliability and validity of the efficacy outcomes. The trial's design and execution will be aligned with the regulatory requirements and scientific standards to provide robust evidence on the efficacy of the investigational product.