Phase 1 Dose-Escalation Study of CC-96191 in Patients with Relapsed or Refractory Acute Myeloid Leukemia

The primary objective of this study is to evaluate the **dose finding** of CC-96191 in subjects with **Relapsed or Refractory Acute Myeloid Leukemia**. This is clinically relevant as determining the optimal dose is crucial for maximizing therapeutic efficacy while minimizing adverse effects in this patient population.

The clinical trial involves a total of **48 participants** diagnosed with **Relapsed or Refractory Acute Myeloid Leukemia**. The study population includes both male and female subjects, with an age range spanning from 18 to 64 years. Participants were selected to include a vulnerable population, although specific inclusion or exclusion criteria were not provided by the sponsor. The general health status of the participants is not detailed, nor are any lifestyle considerations such as diet, physical activity, or habits. The trial aims to gather data from a diverse group within the specified age range, ensuring representation across genders.

The clinical trial is a **Phase 1** study designed to evaluate the safety and efficacy of CC-96191 in subjects with **relapsed or refractory acute myeloid leukemia**. 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 spans from April 8, 2022, to March 24, 2025, 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 is crucial for ensuring that only suitable candidates are enrolled in the study. Following the screening, participants will attend regular follow-up visits, which are structured to monitor their response to the treatment and any potential adverse effects. These visits are integral to maintaining participant safety and collecting consistent data throughout the trial. The end-of-study visit marks the conclusion of the participant's involvement, where final assessments are conducted to evaluate the overall outcomes of the treatment.

The expected length of participant involvement is aligned with the trial's duration, although individual participation may vary depending on specific circumstances. Conditions that may lead to early termination from the study include significant adverse reactions, withdrawal of consent, or any other medical reasons deemed necessary by the investigators. The trial is conducted under strict ethical guidelines, ensuring that participant welfare is prioritized at all stages of the study.

The clinical trial documentation does not provide specific details regarding the **experimental medication** used in the study. Information such as the name, pharmaceutical form, dosage, route, and frequency of administration is not available. Additionally, there is no data on whether the medication is a **paediatric formulation** or if it is classified as an **orphan drug**. The maximum daily dose, total dose, and treatment period are also unspecified.

Details about any **non-experimental treatments** used in the study, such as standard-of-care therapy, placebo, or comparator treatment, are not provided. There is no information on additional relevant aspects of drug administration, dosing schedules, or participant compliance monitoring. The absence of this data limits the ability to describe the treatments comprehensively.

The clinical trial is designed to assess efficacy through a structured evaluation process. The trial is categorized as a Phase 1 study, indicating an early stage of clinical research primarily focused on safety and dosage. The estimated recruitment start date was April 8, 2022, with an anticipated end date of March 24, 2025. Although specific efficacy parameters such as primary or secondary endpoints are not detailed, Phase 1 trials typically involve initial assessments of pharmacokinetics and pharmacodynamics, which may include measuring biomarker levels or other relevant physiological responses. The trial's methodology and schedule for measuring, collecting, and analyzing efficacy data are not specified, but such trials often employ validated scales, laboratory tests, or other scientific instruments to gather data at predetermined intervals. The absence of detailed endpoints suggests that the trial may focus on exploratory outcomes to inform subsequent phases of research.