The purpose of the trial is to assess how well the medication works and how safe it is for people with relapsed or refractory disease. The main goal is to determine the proportion of participants who achieve complete remission after the treatment course, while secondary goals include measuring the overall response rate, the length of time the disease stays controlled such as progression free survival, and the impact on patients’ quality of life. Throughout the study, participants will undergo routine examinations and questionnaires to track response, durability of benefit, and any adverse events.

The purpose of this research is to evaluate how well obinutuzumab works and what side effects it may cause when used as a first treatment for people with MZL who cannot receive local treatments or for whom local treatments have not worked. The medication will be given as a single treatment, meaning it will not be combined with other cancer medications.

During the study, participants will receive obinutuzumab through an intravenous infusion at a dose of 1,000 mg. The treatment period may last up to 30 months. Throughout the study, doctors will monitor the participants’ response to treatment and track any side effects that may occur. The study will also look at how the treatment affects participants’ quality of life and whether any other health conditions develop over time.

Participants in the study will receive the medications through an intravenous infusion, which means the drugs are given directly into a vein. The study will last for about 12 months, during which the response to the treatment will be closely monitored. This includes checking for complete remission, which means the disappearance of all signs of cancer in response to treatment. The study will also document any side effects and how the treatment affects the quality of life of the participants. The goal is to understand how well the combination of Copanlisib and Rituximab works in treating MZL and to identify any potential risks associated with the treatment.

Throughout the study, participants will have regular visits for drug administration, imaging studies like MRI or CT scans, and laboratory tests to monitor their health and the progress of the treatment. The study will also track the time it takes for the best response to occur, how long the response lasts, and the overall survival of the participants. This information will help researchers determine the effectiveness of the treatment and its impact on the participants’ lives.

Participants in the study will first receive a combination of Chlorambucil and Rituximab for a period of six months. After this initial phase, they will continue with a maintenance treatment using only Rituximab, which will be given as a subcutaneous injection for an additional two years. This approach aims to manage the lymphoma effectively over a longer period. The study will also include a group receiving a placebo to compare the results.

The trial will monitor various outcomes, such as the rate of complete remission, which means the disappearance of all signs of cancer in response to treatment, and the overall survival of participants. Other aspects being observed include how long participants remain free from disease progression and any side effects that may occur during and after the treatment. The study is designed to provide valuable information on the potential benefits and risks of using Chlorambucil and Rituximab together for treating MALT Lymphoma.