Ongoing Clinical Trials for Follicular Lymphoma Stage II
There are currently 2 ongoing clinical trials for follicular lymphoma stage II. These trials are testing new treatment combinations to help patients whose disease has either returned after previous treatment or who have been newly diagnosed with advanced stages of the condition. The studies are being conducted across several European countries and involve different medication combinations aimed at improving treatment outcomes.
Clinical trial locations
- France
- Germany
- Italy
- Poland
- Spain
Study of BGB-16673 in combination with drug therapy for patients with relapsed or refractory B-cell malignancies
This trial is testing a new medication called BGB-16673 in combination with other drugs for patients whose B-cell cancer has returned or did not respond to previous treatments. The main investigational drug, BGB-16673, is a BTK-degrader that works by breaking down a specific protein important in B-cell cancers. Depending on which treatment group patients are assigned to, they may also receive other medications such as zanubrutinib, obinutuzumab, glofitamab, or mosunetuzumab.
Who can join this trial:
- Adults aged 18 or older with confirmed B-cell malignancy that has relapsed or is refractory
- Patients who are able to perform daily activities with minimal limitations
- Those with adequate organ and kidney function
- Women who can become pregnant must use effective birth control and have a negative pregnancy test before starting
- Men who are not sterile must also use effective birth control during the study
Who cannot join this trial:
- People under 18 years old
- Those with active cancer involvement in the central nervous system
- Patients with active, uncontrolled infections or significant heart problems
- Those with severe kidney or liver problems
- Pregnant or breastfeeding women
- People with HIV, active hepatitis B or C, or who have had major surgery within 4 weeks
- Those with uncontrolled high blood pressure or other serious medical conditions that could make participation unsafe
The study will be conducted in two parts. The first part will determine the right dose of the drug combinations, while the second part will study how well these doses work and what side effects they may cause. Throughout the trial, doctors will regularly monitor patients’ health, check treatment effectiveness through blood tests and examinations, and track any side effects. The goal is to measure how many patients respond to treatment and how long the response lasts.
Study on the Effectiveness and Safety of Golcadomide and Rituximab for Patients with Newly Diagnosed Advanced Follicular Lymphoma
This trial is focused on patients who have been newly diagnosed with advanced stages of the disease. The treatment combines two medications: Golcadomide and Rituximab. Golcadomide is taken orally in capsule form, while Rituximab is given as an infusion directly into the bloodstream through a vein.
Who can join this trial:
- Adults over 18 years of age
- Those newly diagnosed with advanced stage follicular lymphoma
- Patients who meet specific disease characteristics and laboratory values
- Both male and female participants are eligible
Who cannot join this trial:
- Patients who have not been newly diagnosed with advanced stage disease
- Those outside the specified age range
- People who belong to a clinical trial group not included in this study
The main goal of the study is to see if the treatment can achieve a Complete Metabolic Response, which means that after treatment, tests show no signs of cancer in the body. The trial will also monitor for any side effects or adverse events throughout the treatment period. Participants will receive treatment over time, and their response will be evaluated at different stages, such as 6 months and 12 months after starting.
The study will assess the overall response rate, which is the percentage of participants whose cancer shrinks or disappears, as well as progression-free survival and overall survival. Throughout the treatment, additional medications may be introduced, including vincristine sulfate, pegfilgrastim, bendamustine hydrochloride, cyclophosphamide monohydrate, prednisone, and doxorubicin hydrochloride, administered either intravenously or orally depending on the specific drug.
Summary
There are currently 2 clinical trials available for patients with follicular lymphoma stage II across five European countries: France, Germany, Spain, Italy, and Poland. The trials represent two different treatment approaches: one for patients whose disease has returned or not responded to previous treatments, and another for patients who are newly diagnosed with advanced stages of the condition.
Both Germany, Italy, and Poland are involved in both trials, offering patients in these countries more options for participation. The trials are testing different medication combinations, with BGB-16673 being studied as a novel BTK-degrader in combination with various other agents, while Golcadomide is being evaluated alongside the established medication Rituximab. Both studies emphasize careful monitoring of treatment effectiveness and side effects to determine the best possible outcomes for patients.
