Phase 1b Multicenter Open-label Study of Acalabrutinib with Bendamustine and Rituximab or Venetoclax and Rituximab in Mantle Cell Lymphoma

The primary objective of this study is to evaluate the safety and tolerability of **Acalabrutinib** in combination with Bendamustine and Rituximab (BR) or Venetoclax and Rituximab (VR) in subjects with **Mantle Cell Lymphoma**. This is clinically relevant as it aims to determine the potential of these combination therapies to improve treatment outcomes for patients with this aggressive form of non-Hodgkin lymphoma, which is often challenging to treat effectively.

The clinical trial involves a total of **12 participants** diagnosed with **Mantle Cell Lymphoma**. The study population includes both male and female subjects, with an age range corresponding to categories 3 and 4, which typically represent adults and older adults. Participants were selected to include a vulnerable population, although specific criteria for vulnerability are not detailed. The general health status of the participants is not specified, nor are any lifestyle considerations such as diet, physical activity, or habits. The sponsor has not provided information regarding the main objective of the trial or the principal inclusion criteria.

This clinical trial is a **Phase 1b**, multicenter, open-label study designed to evaluate the safety and efficacy of Acalabrutinib in combination with Bendamustine and Rituximab (BR) or Venetoclax and Rituximab (VR) in subjects with **Mantle Cell Lymphoma**. The trial commenced on October 24, 2016, and is projected to conclude by July 21, 2027. The study is structured to include a series of visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. Participants who meet the inclusion criteria will be enrolled and will undergo a baseline assessment before the initiation of treatment. The trial design does not incorporate randomization or blinding, as it is open-label, allowing both researchers and participants to be aware of the treatment being administered.

Participants will be required to attend regular follow-up visits throughout the study duration to monitor treatment response and assess any adverse events. These visits will include clinical evaluations, laboratory tests, and imaging studies as necessary. The frequency and specific procedures of these follow-up visits will be determined by the study protocol. The end-of-study visit will occur after the completion of the treatment regimen, where final assessments will be conducted to evaluate the overall outcomes and any long-term effects of the treatment.

The expected length of participant involvement will vary depending on individual response to treatment and the specific combination therapy received. Participants may be withdrawn from the study early if they experience unacceptable toxicity, disease progression, or if they choose to withdraw consent. Additionally, any protocol deviations or non-compliance with study procedures may also result in early termination from the study. The trial aims to provide valuable insights into the potential benefits and risks associated with these combination therapies in the treatment of Mantle Cell Lymphoma.

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 absence of specific details, additional relevant information about drug administration, dosing schedules, and participant compliance monitoring cannot be included. The data does not contain any information about the **disease** being studied, the trial's main objective, or any other pertinent details that would typically be included in a clinical trial description.

Efficacy in this clinical trial will be assessed through a structured evaluation process. The trial is categorized as a Phase 2 study, which typically focuses on assessing the efficacy of a treatment in a specific patient population. Although specific endpoints or parameters for efficacy evaluation are not detailed, Phase 2 trials generally involve measuring clinical outcomes that reflect the treatment's impact on the disease. These may include symptom improvement scores, biomarker levels, or disease remission rates, depending on the condition being studied. The methods for measuring and collecting these efficacy parameters are not specified, but they often involve validated scales, laboratory tests, or patient-reported outcomes. The schedule for these assessments is also not provided, but typical timepoints in such trials might include baseline, mid-treatment, and end-of-treatment evaluations. The trial is expected to conclude by July 21, 2027, with recruitment having started on October 24, 2016.