Phase I Study of Iberdomide and CC-98282 in Combination with R-CHOP21 for Untreated Aggressive B-Cell Lymphoma

The primary objective of this study is to determine the **safe dose** of iberdomide (CC-220) in combination with R-CHOP21 and CC-98282 in combination with R-CHOP21 in subjects with newly diagnosed aggressive B-cell lymphoma (a-BCL). Establishing a safe dosage is clinically relevant as it ensures the therapeutic efficacy of the treatment while minimizing potential adverse effects, thereby optimizing patient outcomes in this aggressive form of lymphoma.

The clinical trial involves a total of **107 participants** diagnosed with **newly diagnosed aggressive B-cell lymphoma (a-BCL)**. The study population includes both male and female subjects, with an age range classified under category code "3," which typically corresponds to adults. Participants were selected to include a vulnerable population, although specific criteria for vulnerability are not detailed. The trial does not specify particular lifestyle considerations such as diet, physical activity, or habits. The sponsor has not provided detailed information regarding the main objective of the trial or the principal inclusion criteria.

The clinical trial is designed to evaluate the safety and efficacy of **iberdomide** in combination with R-CHOP21 and CC-98282 in combination with R-CHOP21 for subjects with newly diagnosed aggressive B-cell lymphoma. This is a Phase 3, randomized, double-blind, controlled trial. The estimated recruitment start date was September 27, 2021, with an anticipated end date of October 12, 2026. Participants will be involved in the study for the duration of the trial, which spans approximately five years, unless early termination criteria are met.

The trial includes a sequence of study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. Following successful screening, participants will be randomized into treatment groups. Regular follow-up visits will be scheduled to monitor the safety and efficacy of the treatment regimens. These visits will include assessments such as physical examinations, laboratory tests, and imaging studies to evaluate the response to treatment and any adverse effects. The end-of-study visit will conclude the participant's involvement, where final assessments will be conducted to gather comprehensive data on the treatment outcomes.

Participants may be withdrawn from the study early if they experience significant adverse effects, fail to comply with study procedures, or if the investigator deems it in the participant's best interest. The trial's design ensures that data collected will contribute to understanding the optimal dosing and safety profile of the investigational combinations in treating aggressive B-cell lymphoma.

The clinical trial documentation does not provide specific details regarding the experimental medication, including its name, pharmaceutical form, dosage, route, or frequency of administration. Consequently, no detailed description of the experimental treatment can be provided based on the available data.

Similarly, there is no information available about any non-experimental treatments used in the study, such as standard-of-care therapy, placebo, or comparator treatment. As such, no description of these elements can be included.

Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also absent from the provided data. Therefore, no further details can be offered regarding these aspects of the clinical trial.

The clinical trial is a Phase 3 study with an estimated recruitment start date of September 27, 2021, and an estimated end date of October 12, 2026. The trial is categorized under trial category 1 with a trial category ID of 57904. Efficacy assessments will be conducted to evaluate the outcomes of the intervention. However, specific parameters or endpoints used to evaluate efficacy, as well as the methods and schedule for measuring, collecting, and analyzing these efficacy parameters, are not provided in the available data. The trial will proceed according to the standard protocols for a Phase 3 study, focusing on the collection and analysis of efficacy data to determine the effectiveness of the intervention under investigation.