In short
There are currently 2 clinical trials actively recruiting patients with follicular lymphoma stage III. These studies are testing new combinations of medications aimed at improving treatment outcomes for patients with this advanced form of the disease. The trials are being conducted across multiple European countries including Poland, Germany, Italy, France, and Spain.
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 clinical trial is designed for patients whose B-cell cancers, including follicular lymphoma stage III, have either returned after previous treatment or did not respond to earlier therapies. The study tests different combinations of medications to find safe and effective treatment options for these challenging situations.
Who can participate:
- Adults aged 18 years and older
- Patients with confirmed relapsed or refractory B-cell malignancy that can be measured
- Those with good physical function and ability to perform daily activities with minimal limitations
- Patients with adequate organ function, including kidney function
- Women of childbearing potential must use effective birth control and have a negative pregnancy test before starting treatment
- Men who are not sterile must also use effective birth control during the study
Who cannot participate:
- Patients younger than 18 years
- Those with active central nervous system involvement
- Patients with active, uncontrolled infections
- Those with significant heart problems, severe kidney or liver problems
- Pregnant or breastfeeding women
- Patients with known HIV infection or active hepatitis B or C
- Those who have had major surgery within 4 weeks before starting the study
- Patients with uncontrolled high blood pressure or other serious medical conditions
What the trial aims to achieve:
The study will be conducted in two parts. The first part focuses on determining the right dose of different drug combinations, while the second part will further evaluate how well these doses work and monitor for side effects. Throughout the trial, doctors will carefully track how patients respond to treatment and how long the response lasts. For some participants, the study will also measure the amount of cancer cells remaining in the blood or bone marrow after treatment.
Investigational drugs being tested:
The main experimental medication is BGB-16673, which is an investigational BTK-degrader. This medication works by breaking down a specific protein called BTK that plays an important role in B-cell cancers. BGB-16673 is given as tablets taken by mouth and will be combined with other medications including zanubrutinib, sonrotoclax, mosunetuzumab, obinutuzumab, and glofitamab. Some of these additional medications are given through an intravenous infusion directly into a vein, while others are taken as oral capsules or given as injections under the skin.
Study on the Effectiveness and Safety of Golcadomide and Rituximab for Patients with Newly Diagnosed Advanced Follicular Lymphoma
This trial focuses specifically on patients who have been newly diagnosed with advanced stage follicular lymphoma. The study evaluates a treatment combination of two medications: Golcadomide and Rituximab. This trial offers an opportunity for patients at the beginning of their treatment journey to access potentially effective therapy options.
Who can participate:
- Adults over the age of 18
- Patients who have been newly diagnosed with advanced stage follicular lymphoma
- Those whose disease characteristics match what the study is looking for
- Patients who meet specific laboratory test requirements showing their current health status
- Both male and female participants are eligible
Who cannot participate:
- Patients who do not have newly diagnosed advanced stage follicular lymphoma
- Those who are not within the specified age range for the study
- Patients who belong to a clinical trial group that is not included in this particular study
What the trial aims to achieve:
The main goal of this study is to see if the treatment combination can achieve what is called a Complete Metabolic Response, meaning that after treatment, tests show no signs of cancer in the body. The study will evaluate this response at different time points, including 6 months and 12 months after starting treatment. Researchers will also measure the overall response rate, which is the percentage of participants whose cancer shrinks or disappears. Additionally, the trial will assess progression-free survival, which is the time from the start of treatment until the disease worsens, as well as overall survival. Throughout the study, doctors will carefully monitor for any side effects or adverse events to ensure patient safety.
Investigational drugs being tested:
Golcadomide is an experimental medication being studied for its potential to help treat advanced stage follicular lymphoma. It is taken orally in capsule form. This medication is combined with Rituximab, which is a more established medication commonly used to treat certain types of cancers including follicular lymphoma. Rituximab is given as an infusion directly into the bloodstream through a vein. The trial also incorporates additional medications including vincristine sulfate, pegfilgrastim, bendamustine hydrochloride, cyclophosphamide monohydrate, prednisone, and doxorubicin hydrochloride, which are administered either intravenously or orally depending on the specific drug. The study aims to evaluate how well these medications work together in treating newly diagnosed advanced follicular lymphoma.
Summary
Currently, there are two active clinical trials available for patients with follicular lymphoma stage III across several European countries. These trials represent different treatment approaches depending on the stage of the disease and previous treatment history.
One notable observation is that both trials are being conducted across multiple European countries, with Germany, Italy, and Poland hosting both studies. This geographical distribution provides access opportunities for patients in several locations. France and Spain are participating in the trial for newly diagnosed patients, while all five countries are involved in research efforts for this condition.
The trials take different approaches based on patient needs. The first trial focuses on patients whose disease has returned or not responded to previous treatments, testing a novel BTK-degrader medication called BGB-16673 in various combinations. The second trial specifically targets patients who are newly diagnosed with advanced disease, evaluating the combination of Golcadomide and Rituximab along with additional supportive medications.
Both studies emphasize careful monitoring of treatment effectiveness and safety, with regular assessments throughout the treatment period. Patients interested in participating should discuss these options with their healthcare providers to determine which trial might be most appropriate for their specific situation.
