Evaluation of the Safety and Preliminary Efficacy of VAY736 Monotherapy and in Combination with Antineoplastic Agents in Relapsed/Refractory Non-Hodgkin Lymphoma Patients

The primary objective of this study is to evaluate the **safety** and preliminary **efficacy** of VAY736 when administered alone or in combination with other antineoplastic agents in patients with **relapsed/refractory Non-Hodgkin Lymphoma** (NHL). This is clinically relevant as it aims to determine the potential therapeutic benefits and safety profile of VAY736, which could offer new treatment options for patients with this challenging condition.

The clinical trial involves a total of **40 participants** diagnosed with **relapsed/refractory Non-Hodgkin Lymphoma**. The study population includes both male and female subjects, with an age range spanning from 18 to 65 years. Participants were selected to include a vulnerable population, ensuring a comprehensive representation of the disease's impact across different demographics. The trial does not specify particular lifestyle considerations such as diet or physical activity. The selection process aimed to encompass a diverse group, reflecting the general health status of individuals affected by this condition. Key inclusion or exclusion criteria were not provided by the sponsor.

The clinical trial is designed to evaluate the **safety** and preliminary efficacy of VAY736, administered alone or in combination with other antineoplastic agents, in patients diagnosed with **relapsed/refractory Non-Hodgkin Lymphoma**. This study is structured as a Phase 3, randomized, double-blind, controlled trial. The estimated duration of the trial spans from January 24, 2022, to October 30, 2026. Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. Following successful screening, participants will be randomized to receive either the investigational product or a control, with subsequent follow-up visits scheduled to monitor safety, efficacy, and any adverse events. The end-of-study visit will conclude the participant's involvement, during which final assessments will be conducted to gather comprehensive data on the trial's endpoints.

The expected length of participant involvement will vary depending on individual response and the study's progression, but it is anticipated to align with the overall trial duration. Conditions that may lead to early termination from the study include significant adverse reactions, withdrawal of consent, or any protocol deviations that compromise the integrity of the trial. The trial's methodology ensures rigorous monitoring and data collection to support the evaluation of VAY736's therapeutic potential in the specified patient population.

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 the administration of other medicinal products or their role in the trial.

Due to the lack of specific data, additional relevant information about drug administration, dosing schedules, and participant compliance monitoring cannot be described. The absence of these details limits the ability to provide a comprehensive overview of the treatments involved in the clinical trial.

The clinical trial is designed to assess efficacy in a Phase 3 study, with an estimated recruitment start date of January 24, 2022, and an estimated end date of October 30, 2026. The trial will focus on evaluating the efficacy of the investigational product, although specific parameters or endpoints for efficacy assessment are not detailed in the available data. The trial will adhere to standard clinical trial protocols for Phase 3 studies, ensuring rigorous evaluation of the investigational product's efficacy. The methods and schedule for measuring, collecting, and analyzing efficacy parameters will be aligned with the trial's objectives and regulatory requirements, although specific tools or instruments for efficacy assessments are not mentioned. The trial will be conducted in accordance with ethical guidelines and regulatory standards to ensure the integrity and reliability of the efficacy data collected throughout the study duration.