A trial looking at lenalidomide for mantle cell lymphoma that has come back or is no longer responding to treatment (SPRINT)

Cancer type:

Low grade lymphoma
Lymphoma
Non-Hodgkin lymphoma

Status:

Results

Phase:

Phase 2

This trial looked at lenalidomide (Revlimid) for mantle cell lymphoma when other treatments are no longer working, or it has come back after treatment.

More about this trial

Mantle cell lymphoma is a type of non Hodgkin lymphoma (NHL), cancer of the lymphatic system. Doctors often treat it with chemotherapy, but sometimes the treatment doesn’t work, or the lymphoma starts to grow again. This is sometimes called refractory or relapsed lymphoma. 
 
Doctors can choose from a few different drugs to use if this happens. But they have no way of knowing which treatment is best.
 
Lenalidomide is type of biological therapy. It works mainly by helping the body’s immune system target the cancer cells. In this trial, they compared lenalidomide to several different cancer drugs already used, to see if it worked better.
 
The aims of this trial were to find out:
  • how well lenalidomide works for people with mantle cell lymphoma
  • how it affects quality of life

Summary of results

This trial showed that lenalidomide worked better than chemotherapy for mantle cell lymphoma that had continued to grow despite other treatment.
 
This trial recruited 254 people with mantle cell lymphoma from 12 different countries, including the UK. They had already had treatment for their lymphoma. 
 
They were put into 1 of 2 groups at random, and:
  • 170 people were in the lenalidomide group
  • 84 people were in the standard treatment group

The doctors could decide which treatment was best for their patients in the standard treatment group. Of the 84 people in this group:
  • 27 had rituximab
  • 20 had gemcitabine
  • 18 had fludarabine
  • 11 had chlorambucil
  • 8 had cytarabine
The research team looked at how well the treatments worked. They found that out of 152 of the people in the lenalidomide group, the lymphoma had:
  • gone away completely in 8 people (5%)
  • got smaller in 60 people (35%)
  • stayed the same in 50 people (29%)
  • continued to grow in 34 people (20%)
And out of 79 of the people in the standard treatment group, the lymphoma had:
  • not gone away completely in anyone
  • got smaller in 9 people (11%)  
  • stayed the same in 44 people (52%) 
  • continued to grow in 26 people (31%) 
They were unable to assess how well treatment worked for 18 people in the lenalidomide group, and 5 people in the standard treatment group.
 
 
 
 
They also looked at the most common length of time before the lymphoma started to grow again. They found it was:
  • 8.7 months for the lenalidomide group
  • 5.2 months for the standard treatment group
When they look at how long people lived in each group, they found the most common time was:
  • 28 months for the lenalidomide group
  • 21 months for the standard treatment group
The trial team also looked at the side effects for most of the people taking part:
  • 140 out of 167 people (84%) in the lenalidomide group had side effects
  • 50 out of 83 people (60%) in the standard treatment group had side effects
More people in the lenalidomide group had serious side effects, including a drop in white blood cells, red blood cells and clotting blood cells (platelets). These side effects were managed with treatments such as growth factors Open a glossary item.
 
The lenalidomide group also had more of the less serious side effects such as tiredness, diarrhoea, constipation and cold like symptoms.
 
The number of people who stopped treatment because of side effects was similar in both groups. It was 25 out of 167 (15%) in the lenalidomide group, and 13 out of 83 (16%) in the standard treatment group.
 
Patients were asked to fill in Quality of Life questionnaires at various points in the trial. The results showed that quality of life did not go down with treatment. Those in the lenalidomide group had the same or better quality of life as those in the standard treatment group.
 
The trial team concluded that lenalidomide worked better than the other treatments for mantle cell lymphoma that had continued to grow despite previous treatment. Although lenalidomide did cause more side effects, the doctors were able to treat them.
 
We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item) and published in a medical journal. The figures we quote above were provided by the trial team who did the research. We have not analysed the data ourselves.

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Prof Simon Rule

Supported by

Celgene Corporation
Experimental Cancer Medicine Centre (ECMC)

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

5958

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Over 60,000 cancer patients enrolled on clinical trials in the UK last year.

Last reviewed:

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