A PHASE II STUDY OF CHLORAMBUCIL IN COMBINATION WITH SUBCUTANEOUS RITUXIMAB FOLLOWED BY MAINTENANCE THERAPY WITH SUBCUTANEOUS RITUXIMAB IN PATIENTS WITH EXTRANODAL MARGINAL ZONE B-CELL LYMPHOMA OF MUCOSA ASSOCIATED LYMPHOID TISSUE (MALT LYMPHOMA)
This study aims to find out if combining two medicines, chlorambucil and rituximab, is an effective treatment for a type of cancer called Extranodal Marginal Zone B-cell Lymphoma, also known as MALT lymphoma. Participants will receive chlorambucil tablets and rituximab, first as an infusion into a vein and then as an injection under the skin. After the initial treatment, they'll continue with rituximab injections for a longer period. Researchers will be looking at how many patients go into remission (meaning the cancer can't be found) after six months, as well as if the treatment helps people live longer and comfortably. The study is particularly interested in any side effects and how long the treatment keeps the cancer under control.
At a glance
What is this study about?
This research study is focused on a specific type of cancer called Extranodal Marginal Zone B-cell Lymphoma, often shortened to MALT lymphoma. This is a slow-growing cancer that starts in certain immune cells (B-cells) and can appear in different parts of the body, often where there's been long-term inflammation, like the stomach or salivary glands.
The study is investigating a new way to treat MALT lymphoma by combining two different medicines: chlorambucil and rituximab. Chlorambucil is a chemotherapy drug that works by killing cancer cells. Rituximab is a special type of drug called an antibody, which specifically targets and destroys cancer cells with certain markers on their surface. The goal is to see if using these two medicines together is more effective than standard treatments and helps more patients go into remission.
This is a Phase II study, which means it's testing whether the new treatment approach is safe and effective enough to be studied in a larger group of people later on. The main thing the researchers want to find out is how many patients achieve a "complete remission" – meaning there are no signs of the cancer left – after six months of treatment. They will also be looking closely at how long people stay well, how long the treatment works, and any side effects people might experience.
Key takeaways
- This study explores a new combination treatment for MALT lymphoma.
- It uses chlorambucil and rituximab, given in two ways.
- The main goal is to see how many people go into remission after six months.
- Researchers will also track side effects and long-term health outcomes.
- Participation involves treatment and long-term follow-up visits.
Who may be eligible?
To join this study, you need to be at least 18 years old. The study is open to both men and women, with no upper age limit.
Since this study is specifically for people with Extranodal Marginal Zone B-cell Lymphoma, also known as MALT lymphoma, you would need to have received this diagnosis to be considered. The doctors running the study will check your medical history and conduct tests to make sure you fit all the necessary criteria for participation.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Have you been diagnosed with Extranodal Marginal Zone B-cell Lymphoma (MALT lymphoma)?
- Are you willing to attend regular clinic appointments and receive treatment as required?
- Are you able to take chemotherapy medication and receive injections/infusions?
What does participation involve?
If you decide to take part in this study, you would first have an 'induction phase' of treatment lasting about six months. During this time, you would receive chlorambucil, likely as tablets you take, and rituximab. The rituximab will initially be given as an infusion, meaning it goes directly into your vein through a drip. Later, it will be given as an injection under your skin, which is usually quicker and can sometimes be done at home or in a clinic.
After the initial six months, if the treatment is working well, you would then move into a 'maintenance phase' where you would continue to receive rituximab as an injection under your skin for a longer period. Throughout the study, you would attend regular appointments for check-ups, blood tests, and scans to see how you are responding to the treatment and to monitor for any side effects. The total duration of your participation would involve the treatment period and then regular follow-up visits to track your health over several years, potentially up to five years or more.
Potential risks and benefits
Locations (2)
- —UnverifiedFrance
- —UnverifiedItaly
Common questions
What is MALT lymphoma?
MALT lymphoma is a type of slow-growing cancer that affects immune cells called B-cells. It can appear in different parts of the body, not just in lymph nodes.
What are the medicines used in this study?
The study uses two medicines: chlorambucil, a chemotherapy drug, and rituximab, a drug that targets specific cancer cells.
How will the medicines be given?
Chlorambucil will likely be taken as tablets. Rituximab will first be given through a drip into your vein, and then later as an injection under your skin.
How long will the treatment last?
The initial treatment phase is about six months, followed by a longer period of 'maintenance' treatment with rituximab injections. The study will follow your health for several years.
What does 'complete remission' mean?
Complete remission means that after treatment, doctors can no longer find any signs of the cancer in your body using tests and scans.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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