
“I think it’s really important that people keep signing up to these type of trials to push research forward.”
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at lenalidomide (Revlimid) for diffuse large B cell lymphoma (DLBCL) that has continued to grow during treatment, or come back after treatment.
DLBCL is one of the most common types of high grade non Hodgkin lymphoma. The standard treatment is a combination of chemotherapy and a monoclonal antibody called rituximab. This treatment is called R-CHOP.
For many people, R-CHOP gets rid of the lymphoma cells (gets it into remission). But sometimes the lymphoma does not go away, or comes back. When this happens, doctors may use other chemotherapy drugs. One of the treatments they can use is called R-GEM-P. It is a combination of the following drugs
In this trial, they are looking at a drug called lenalidomide which is a type of biological therapy. It affects how the immune system works. The researchers want to find out if adding lenalidomide to the drugs gemcitabine, methylprednisolone and rituximab (LR-GEM) is a better treatment for DLBCL than the drug combination above.
You may be able to enter this trial if all of the following apply.
You cannot enter this trial if any of the following apply. You
This is a phase 2 trial. In total, the researchers will need about 92 people to take part. People taking part are put into 1 of 2 treatment groups by a computer. Neither you nor your doctor can choose which group you are in. This is called randomisation.
People in one group have R-GEM-P which consists of the following drugs
People in the other group have LR-GEM which consists of the drugs
People in both groups have treatment over 28 days. This includes the time you have treatment and then a break to allow you to recover before starting treatment again. This is called a cycle of treatment. In total you will have 3 cycles of treatment taking about 3 months.
You have gemcitabine, cisplatin and rituximab as an injection into a vein. Methylprednisolone and lenalidomide are tablets. You have most of your treatment as an outpatient but you will probably have 1 overnight stay in hospital half way through each cycle of treatment.
After 1 cycle of treatment you will have a CT scan. If your lymphoma has got worse your doctors will stop the trial treatment and you will be offered other treatment. If your lymphoma remains the same or has got better you will have 2 further cycles of treatment.
After 3 cycles of treatment you have a PET-CT scan and a CT scan. You might also have a bone marrow test.
If there are no signs of any lymphoma (a complete response), your doctor may recommend that you have a stem cell transplant.
If your lymphoma has improved and is now only in one place in your body, your doctor may recommend radiotherapy. You may also go on to have a stem cell transplant.
If you are in the group having lenalidomide and there are no signs of any lymphoma after 3 cycles of treatment, you may be offered this drug for a further 12 months.
You take the tablets once a day, for 3 weeks out of every 4.
You see the doctor and have some tests before taking part in this trial. These tests include
During treatment you see your doctor regularly for a physical examination and blood tests. If you are in the group having cisplatin the doctors will also check your hearing before every cycle of treatment.
Once all treatment has been completed people in the group having gemcitabine, cisplatin, methylprednisolone and rituximab will see the trial team
You have a CT scan after 3 months and again 12 months after your treatment has finished.
People in the group having lenalidomide may go on to have this drug for a further 12 months. During this time, the doctor or research nurse will see you every 4 weeks. You have blood tests at these visits. You have a CT scan after 3 months and again after 12 months. After you have finished the lenalidomide you will see the trial team
The most common side effects for both rituximab, gemcitabine, methylprednisolone and cisplatin (R-GEM-P) and lenalidomide, rituximab, gemcitabine, and methylprednisolone (LR-GEM) can include
This is not a complete list of side effects. You doctor or nurse will talk to you about other possible side effects before you agree to take part in the trial.
We have more information on
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor David Cunningham
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
The Royal Marsden NHS Foundation Trust
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
“I think it’s really important that people keep signing up to these type of trials to push research forward.”