Safety and Tolerability Assessment of Odronextamab and Cemiplimab in Adult Patients with B-Cell Non-Hodgkin’s Lymphoma

The primary objective of this study is to evaluate the **safety** and **tolerability** of odronextamab and cemiplimab in adult patients diagnosed with **B-Cell Non-Hodgkin’s Lymphoma (B-NHL)**. Understanding the safety profile and tolerability of these treatments is clinically significant as it informs healthcare professionals about potential adverse effects and the overall feasibility of these therapies in managing B-NHL. No secondary objectives are provided for this study.

The clinical trial involves a total of **17 participants** diagnosed with **B-Cell Non-Hodgkin’s Lymphoma (B-NHL)**. The study population includes both male and female subjects, with an age range spanning from 18 to 64 years. Participants were selected without targeting any vulnerable populations. The general health status of the participants is not specified, and there are no specific lifestyle considerations such as diet or physical activity mentioned. The selection criteria for the trial population have not been detailed by the sponsor.

The clinical trial is designed to evaluate the **safety** and tolerability of odronextamab and cemiplimab in adult patients diagnosed with **B-Cell Non-Hodgkin’s Lymphoma (B-NHL)**. This study is structured as a Phase 1 trial, which is typically the initial phase in clinical research aimed at assessing the safety profile of investigational drugs. The trial employs a randomized, double-blind, controlled design to ensure unbiased results and to maintain the integrity of the data collected. The estimated duration of the trial spans from January 11, 2016, to December 25, 2026, allowing for comprehensive data collection and analysis over a significant period.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to determine eligibility based on predefined criteria. This initial visit is crucial for ensuring that only suitable candidates are enrolled in the trial. Following the screening, participants will attend regular follow-up visits, which are scheduled to monitor their health status, assess the effects of the treatment, and collect necessary data. These visits are integral to the trial as they provide ongoing safety assessments and allow for the collection of efficacy data. The trial will conclude with an end-of-study visit, where final evaluations are conducted, and participants are debriefed on their involvement in the study.

The expected length of participant involvement in the trial is contingent upon individual response to the treatment and adherence to the study protocol. Participants may be subject to early termination from the study if they experience adverse effects that compromise their safety, if they withdraw consent, or if they fail to comply with the study requirements. The trial is conducted under strict ethical guidelines to ensure the safety and well-being of all participants throughout the study duration.

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, which typically focuses on assessing safety, tolerability, and pharmacokinetics, but may also include preliminary efficacy assessments. The trial is scheduled to conclude by December 25, 2026, with recruitment having commenced on January 11, 2016. Although specific efficacy endpoints are not detailed, Phase 1 trials often utilize a range of parameters such as biomarker levels, symptom improvement scores, or other relevant clinical measures to evaluate efficacy. These parameters are typically measured at predefined intervals throughout the trial to monitor changes over time. The data collected will be analyzed using appropriate statistical methods to determine the efficacy of the investigational product. The trial's methodology ensures that efficacy assessments are conducted in a systematic and scientifically rigorous manner, adhering to the standards expected in clinical research.