Safety and Tolerability Assessment of Odronextamab in Patients with CD20-Positive B-Cell Non-Hodgkin Lymphoma

The primary objective of this study is to evaluate the **safety** and **tolerability** of Odronextamab in patients diagnosed with **B-cell non-Hodgkin lymphoma (NHL)**. This is clinically relevant as it aims to determine the potential adverse effects and overall patient tolerance to the treatment, which is crucial for assessing its viability as a therapeutic option for this type of malignancy.

The clinical trial involves a total of **233 participants** diagnosed with **B-cell non-Hodgkin lymphoma (NHL)**. The study population includes both male and female subjects, encompassing an age range that includes adults and older adults. Participants were selected to ensure a representative sample of the general population affected by this condition, with consideration given to the inclusion of vulnerable populations. The trial does not specify particular lifestyle considerations such as diet or physical activity. The sponsor has not provided detailed information regarding the main objective or specific inclusion and exclusion criteria for this study.

The clinical trial is designed to evaluate the **safety** and tolerability of odronextamab in patients diagnosed with **B-cell non-Hodgkin lymphoma (NHL)**. This study is structured as a Phase 1 trial, which is typically the initial phase in clinical research focusing on assessing the safety profile of a new investigational drug. The trial is expected to run from February 15, 2016, to April 15, 2025, encompassing a comprehensive evaluation period to gather sufficient data on the investigational product's effects.

The trial employs a randomized, double-blind, controlled design to ensure the reliability and validity of the results. Participants will be randomly assigned to either the treatment group receiving odronextamab or a control group, with neither the participants nor the investigators aware of the group assignments, thereby minimizing bias. The study will include several key visits: an initial screening visit to determine eligibility based on predefined criteria, multiple follow-up visits to monitor safety and collect data on the drug's effects, and a final end-of-study visit to conclude the participant's involvement and gather final data.

Participant involvement is expected to last throughout the trial duration unless specific conditions necessitate early termination. Such conditions may include adverse reactions to the investigational drug, withdrawal of consent, or any other medical or ethical reasons deemed significant by the study investigators. The trial's design and procedures are meticulously crafted to ensure participant safety while achieving the study's scientific objectives.

The clinical trial involves the administration of an **experimental medication**. However, specific details regarding the name, pharmaceutical form, dosage, route, and frequency of administration of the experimental medication are not provided in the available data. The trial documentation does not specify whether the medication is a **paediatric formulation** or if it is classified as an **orphan drug**. Additionally, there is no information on the maximum daily dose, total dose, or treatment period for the experimental medication.

In this clinical trial, there is no mention of any **non-experimental treatments** such as standard-of-care therapy, placebo, or comparator treatment being used. The data does not provide details on any additional relevant information about drug administration, dosing schedules, or participant compliance monitoring. The absence of these details suggests that the trial documentation may be incomplete or that such information is not applicable to this particular study.

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 February 15, 2016, with an anticipated end date of April 15, 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 a focus on exploratory outcomes, which are common in early-phase trials to inform subsequent research phases.