Phase 2b Open-label Study of Selinexor in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

The primary objective of this study is to evaluate the efficacy of **Selinexor (KPT-330)** in patients with **relapsed/refractory Diffuse Large B-Cell Lymphoma (DLBCL)**. This is clinically relevant as DLBCL is an aggressive form of non-Hodgkin lymphoma, and patients with relapsed or refractory disease often have limited treatment options. Assessing the efficacy of Selinexor could provide valuable insights into potential therapeutic strategies for this patient population.

The clinical trial involves participants diagnosed with **Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)**. The study population includes both male and female subjects, with an age range categorized as adults. The trial does not specifically target a vulnerable population. The sponsor has not provided information regarding the total number of participants or specific lifestyle considerations such as diet, physical activity, or habits. The selection criteria for the trial population have not been disclosed, and no principal inclusion or exclusion criteria have been specified. The general health status of the participants is not detailed in the available data.

The clinical trial is designed as a **Phase 2b open-label study** to evaluate the efficacy and safety of Selinexor (KPT-330) in patients with **relapsed/refractory diffuse large B-cell lymphoma (DLBCL)**. The trial is set to commence recruitment on January 11, 2022, and is expected to conclude by September 25, 2026. Participants will be involved in the study for a duration that aligns with the trial's timeline, subject to their response to the treatment and adherence to the study protocol.

The trial will include a sequence of study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. Following successful screening, participants will undergo regular follow-up visits to monitor their response to the treatment and any adverse effects. These visits are crucial for collecting data on the primary and secondary endpoints of the study. The end-of-study visit will mark the conclusion of a participant's involvement, where final assessments will be conducted to evaluate the overall outcomes of the treatment.

Participants may be subject to early termination from the study if they experience significant adverse effects, fail to comply with the study protocol, or if the investigator deems it necessary for their safety. The study's open-label design means that both the participants and the investigators will be aware of the treatment being administered, allowing for a comprehensive evaluation of Selinexor's impact on the targeted medical condition.

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 a comprehensive description of the treatments used in this clinical trial.

The clinical trial is designed to assess efficacy within the context of a Phase 4 study. The trial is scheduled to commence recruitment on January 11, 2022, with an estimated completion date of September 25, 2026. Efficacy assessments will be conducted using predefined parameters, although specific endpoints and methods for measuring efficacy are not detailed in the available data. The trial will follow a structured timeline to ensure systematic data collection and analysis, adhering to the standards expected in a Phase 4 clinical trial. The focus will be on evaluating the effectiveness of the intervention under real-world conditions, contributing to the understanding of its impact on the target medical condition. The trial will employ rigorous methodologies to ensure the reliability and validity of the efficacy data collected throughout the study period.