An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial

The primary objective of this extension study is to obtain long-term **safety** data for subjects who have completed a prior clinical trial involving **venetoclax**. This is clinically relevant as it provides critical information on the sustained safety profile of venetoclax, a Bcl-2 family protein inhibitor, in the treatment of conditions such as **chronic lymphocytic leukemia**, **non-Hodgkin's lymphoma**, **multiple myeloma**, **acute myeloid leukemia**, and **acute lymphocytic leukemia**. The study does not list any secondary objectives.

The clinical trial involves a total of **136 participants** who have previously completed a venetoclax study. The study population includes both **male and female subjects** within the **age range** of 18 to 64 years. Participants are individuals diagnosed with conditions such as **chronic lymphocytic leukemia**, non-Hodgkin's lymphoma, multiple myeloma, acute myeloid leukemia, and acute lymphocytic leukemia. The trial population was selected based on the completion of a prior venetoclax study, with the investigator's assessment that continued treatment is beneficial. Participants are required to comply with protocol procedures, and those with multiple myeloma must adhere to specific antibiotic prophylaxis guidelines. The study includes a vulnerable population, and all participants or their legally authorized representatives have provided informed consent. Lifestyle considerations such as diet and physical activity are not specified in the available data.

The clinical trial is designed as a **randomized**, **double-blind**, and **controlled** study to evaluate the long-term safety of **venetoclax** in patients who have completed a prior venetoclax clinical trial. The trial targets individuals with conditions such as **chronic lymphocytic leukemia**, **non-Hodgkin's lymphoma**, **multiple myeloma**, **acute myeloid leukemia**, and **acute lymphocytic leukemia**. The study is expected to run from October 29, 2020, to February 27, 2026, with participants involved for a maximum treatment period of 55 days. The trial involves the administration of venetoclax in the form of film-coated tablets, with a maximum daily dose of 1200 mg and a total dose not exceeding 1980 g.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to confirm eligibility based on the completion of a prior venetoclax study and the investigator's assessment of the patient's best interest. Follow-up visits will be scheduled to monitor the safety and efficacy of the treatment, with adverse event collection as the primary endpoint. The end-of-study visit will conclude the participant's involvement, ensuring all safety data is collected and any necessary follow-up care is arranged.

Participant involvement is contingent upon adherence to protocol-mandated procedures, including pregnancy avoidance measures and, for those with multiple myeloma, adherence to specific antibiotic prophylaxis guidelines. Conditions that may lead to early termination from the study include non-compliance with study procedures or the occurrence of adverse events that compromise participant safety. The trial is conducted under the oversight of an independent ethics committee or institutional review board, with informed consent obtained from all participants or their legally authorized representatives prior to any study-specific procedures.

The clinical trial involves the administration of **Venetoclax**, a small molecule Bcl-2 family protein inhibitor, which is utilized in the form of a **film-coated tablet**. The active substance, **venetoclax**, is of chemical origin and is manufactured by ABBVIE DEUTSCHLAND GMBH & CO. KG. The pharmaceutical form is designed for **oral** administration. The dosing regimen allows for a maximum daily dose of 1200 mg, with a total maximum dose of 1980 g over a treatment period not exceeding 55 days. The trial does not involve a pediatric formulation, and the product is not classified as an orphan drug.

In this study, no non-experimental treatments such as standard-of-care therapy, placebo, or comparator treatments are specified. The focus is solely on the administration of **Venetoclax** to gather long-term safety data from subjects who have completed a prior Venetoclax clinical trial. Participant compliance with the dosing schedule is monitored to ensure adherence to the prescribed regimen. The trial aims to provide comprehensive safety data to support the continued use of Venetoclax in clinical settings.

The efficacy of **Venetoclax** in the clinical trial will be assessed primarily through the collection of adverse events. This endpoint is designed to gather comprehensive safety data for subjects who have completed a prior Venetoclax clinical trial and are continuing treatment in this extension study. The trial aims to obtain long-term safety data, which is crucial for understanding the extended use of Venetoclax in patients. The collection of adverse events will be systematically conducted throughout the trial duration, ensuring that any potential safety concerns are identified and addressed promptly. The data collected will be analyzed to evaluate the safety profile of Venetoclax, contributing to the overall assessment of its efficacy in the context of long-term treatment. The trial is structured to ensure rigorous monitoring and documentation of adverse events, providing valuable insights into the safety and efficacy of Venetoclax for ongoing patient care.