A trial looking at adding lenalidomide to other cancer drugs to treat diffuse large B cell lymphoma (LEGEND)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Blood cancers

High grade lymphoma

Lymphoma

Non-Hodgkin lymphoma

Status:

Closed

Phase:

Phase 2

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.

More about this trial

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

Gemcitabine
Cisplatin
A steroid called methylprednisolone
Rituximab

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.

Who can enter

You may be able to enter this trial if all of the following apply.

You have diffuse large B cell lymphoma (DLBCL)
Your lymphoma has continued to grow or come back after treatment with rituximab and an anthracycline drug such as doxorubicin or epirubicin
You have satisfactory blood test results
You are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
You are willing to use reliable contraception for a month before starting treatment and for 12 months afterwards if there is any chance you or your partner could become pregnant
You are at least 18 years old

You cannot enter this trial if any of the following apply. You

Have lymphoma in your brain or spinal cord
Have had a stem cell transplant
Have already had lenalidomide
Have had other anti cancer drugs in the last 3 weeks
Have had an experimental drug in the last 4 weeks
Have not recovered from the side effects of earlier treatment
Have had treatment with erythropoietin (EPO) or similar drugs in the last 4 weeks
Have had another cancer in the past 5 years apart from non melanoma skin cancer, carcinoma in situ of the cervix or in the breast that has been successfully treated
Have taken the combined oral contraceptive pill in the last 4 weeks
Have had hormone replacement therapy (HRT ) in the last 4 weeks
Have a long term or current infection
Have diabetes that is poorly controlled
Have chronic congestive heart failure (CCF), coronary artery disease or another serious heart or lung condition
Have problems with your hearing that the trial doctors think may get worse if you have cisplatin
Are known to be HIV, hepatitis B or hepatitis C positive
Are known to be allergic or sensitive to any of the drugs in the trial
Have another medical condition or mental health problem that could affect your taking part
Are pregnant or breastfeeding

Trial design

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

Gemcitabine
Methylprednisolone
Rituximab
Lenalidomide

LEGEND trial diagram

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.

If you have a stem cell transplant you start lenalidomide 3 months after your transplant
If you have radiotherapy you start lenalidomide 6 weeks after you finish treatment
If you are not having either radiotherapy or a stem cell transplant you go straight on to have the lenalidomide

You take the tablets once a day, for 3 weeks out of every 4.

Hospital visits

You see the doctor and have some tests before taking part in this trial. These tests include

A physical examination
Heart trace (ECG )
Blood tests
CT scan
PET-CT scan
Bone marrow test
Hearing test

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

Every 3 months for the first year
Every 6 months for the next 2 years
Once a year for the following 2 years

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

Every 6 months for the next 2 years
Once a year for 2 years

Side effects

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

A drop in blood cells causing an increased risk of infection, bruising and bleeding
Feeling or being sick
A sore mouth and mouth ulcers
Taste changes
Loss of appetite
Diarrhoea
Constipation
Tiredness (fatigue)
Blood clots
Loss of fertility (ability to have children)

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