Study on the Effectiveness and Safety of Golcadomide and Rituximab for Patients with Newly Diagnosed Advanced Follicular Lymphoma
This trial is investigating a combination treatment approach for patients who have been newly diagnosed with advanced stage follicular lymphoma. The treatment combines two medications: Golcadomide (also known by its code name CC-99282), which is taken orally in capsule form, and Rituximab, which is given directly into the bloodstream through a vein as an infusion.
Who can participate: The trial is open to adults over 18 years of age who have been newly diagnosed with advanced stage follicular lymphoma. Participants must meet specific disease characteristics that match what the study is looking for, and their blood test results must fall within certain acceptable ranges. Both men and women can join the study, and participants must meet certain criteria related to reproductive capacity.
Who cannot participate: Patients who have not been diagnosed with newly diagnosed advanced stage follicular lymphoma, those who fall outside the specified age range, or those who belong to clinical trial groups not included in this study cannot participate.
What the trial is studying: The main goal of this trial is to determine whether the combination of Golcadomide and Rituximab can achieve a Complete Metabolic Response, which means that tests show no signs of cancer remaining in the body after treatment. The study will evaluate participants at regular intervals, including at 6 months and 12 months after starting treatment.
Throughout the treatment period, researchers will also carefully monitor for any side effects or negative health impacts, known as Treatment-Emergent Adverse Events. Additionally, the study will measure the overall response rate, which is the percentage of participants whose cancer shrinks or disappears, as well as progression-free survival (the time until the disease worsens) and overall survival (the time from treatment start until death).
During the trial, patients may also receive additional medications including vincristine sulfate, pegfilgrastim, bendamustine hydrochloride, cyclophosphamide monohydrate, prednisone, and doxorubicin hydrochloride. These are administered either through infusion or taken orally, depending on the specific medication.
About the investigational drugs: Golcadomide is a medication currently being studied for its potential to help treat this type of cancer by interfering with specific pathways that cancer cells use to grow and survive. It is not yet widely used in regular medical practice, as it remains under investigation. Rituximab is an established medication that has been used to treat various types of lymphoma. It works by targeting and destroying specific cancer cells, particularly those with a protein called CD20 on their surface.
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