Pembrolizumab in Combination With R-ICE Chemotherapy in Relapsed/Refractory Diffuse Large B-cell Lymphoma
This study is for people with a type of blood cancer called diffuse large B-cell lymphoma that has either returned after initial treatment or hasn't responded well to it. Doctors want to see if adding a drug called pembrolizumab to a standard chemotherapy treatment (R-ICE) works better than R-ICE alone. The study is a Phase II trial, meaning it's still in the earlier stages of testing for effectiveness and safety. Participants will be split into two groups: one will receive R-ICE chemotherapy, and the other will get pembrolizumab alongside R-ICE. For some patients, this will be followed by a stem cell transplant and maintenance pembrolizumab, depending on how they respond to treatment.
At a glance
What is this study about?
This study is researching a treatment for a type of cancer that affects white blood cells called diffuse large B-cell lymphoma. This happens when the cancer has either returned after initial treatment, or it hasn't responded to previous treatments. The main goal is to find out if a new combination of medicines can be more effective than the usual treatment.
The study will compare two different treatment approaches. One group of patients will receive a standard chemotherapy treatment called R-ICE. The other group will receive the same R-ICE chemotherapy, but with an additional drug called pembrolizumab. Pembrolizumab is a type of immunotherapy that helps your body's immune system fight cancer. Doctors want to see if adding this drug improves the treatment's success.
After three cycles of chemotherapy, some patients who have responded well will then have a stem cell transplant. Patients in the group receiving pembrolizumab will also continue to receive pembrolizumab as a maintenance treatment for about a year after the transplant. This trial will help doctors understand if this new combination leads to better outcomes for people with this condition.
Key takeaways
- This study compares a new drug combination for diffuse large B-cell lymphoma.
- It's for people whose lymphoma has returned or didn't respond to previous treatment.
- The new combination includes a standard chemotherapy plus pembrolizumab.
- Some patients will have a stem cell transplant, and some will get maintenance treatment.
- Your health will be closely monitored throughout the study.
Who may be eligible?
To join this study, you would need to have been diagnosed with diffuse large B-cell lymphoma that has a specific marker (CD20 positive). Your lymphoma must also have come back after earlier treatments, or it didn't respond to those treatments.
You would need to be well enough to receive strong treatments, meaning you can potentially have high-dose chemotherapy and a stem cell transplant if your cancer responds. Doctors will check your general health and how well you can do daily activities. You'll also need to have positive cancer findings on scans that match what doctors see in your body.
There are also some things that would mean you couldn't join. For example, if you've already had many previous treatments for lymphoma (more than two lines of treatment), or if you've had certain types of radiotherapy or chemotherapy very recently. You must also be 18 years old or older.
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.
- Is my diffuse large B-cell lymphoma CD20 positive?
- Has my lymphoma come back or not responded to prior treatments?
- Am I generally well enough for intensive treatments like chemotherapy and a stem cell transplant?
- Am I 18 years old or older?
- Have I had fewer than two lines of previous lymphoma treatments?
What does participation involve?
If you join this study, you'll be randomly assigned to one of two treatment groups, like flipping a coin, though three out of four people will be in the group getting the new drug combination. You'll receive chemotherapy, either R-ICE alone or R-ICE plus pembrolizumab, for three cycles. Each cycle involves several visits for treatment and check-ups.
If your lymphoma responds well, you might then have a stem cell transplant. This involves more hospital visits and close monitoring. If you're in the group receiving pembrolizumab, you'll continue to get this drug every three weeks for about a year after your transplant to help keep the cancer from coming back. Throughout the study, you'll have regular scans and blood tests to monitor your health and how well the treatment is working. Doctors and nurses will explain all your appointments and what to expect at each stage.
Potential risks and benefits
Locations (2)
- The Beatson West of Scotland Cancer CentreVerified postcodeGlasgow, United Kingdom
- Oxford Cancer & Haematology Centre, The Churchill HospitalVerified postcodeHeadington, United Kingdom
Common questions
What is diffuse large B-cell lymphoma?
It's a type of cancer that starts in white blood cells called lymphocytes, affecting the lymph nodes and other parts of the body.
What is pembrolizumab?
It's an immunotherapy drug that helps your body's immune system fight cancer cells more effectively.
What is a 'relapsed' or 'refractory' lymphoma?
Relapsed means the cancer has come back after treatment. Refractory means the cancer didn't respond well to earlier treatments.
What is a stem cell transplant?
It's a procedure where healthy blood-forming stem cells are given to replace diseased ones, often after high-dose chemotherapy.
Will I definitely get the new drug?
You'll be randomly assigned to one of two groups; there's a higher chance (3 out of 4) that you'll receive the new drug combination.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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