Purpose of trial
The aim of this trial is to compare different first-line treatments for people aged 60 and over with mantle cell lymphoma.
People with mantle cell lymphoma are treated with intensive chemotherapy and a stem cell transplant if they are fit enough. However, many people over 60 are not able to have such intensive treatment.
This trial is comparing:
- ibrutinib combined with rituximab (an antibody therapy), followed by rituximab maintenance against
- rituximab combined with chemotherapy (chemotherapy chosen on a case-by-case basis by the doctor before each person is randomised), followed by rituximab maintenance.
Ibrutinib is a newer drug that targets Bruton’s tyrosine kinase (BTK), which is part of a pathway that helps B cells to stay alive and divide (multiply). Blocking this pathway causes lymphoma cells to die and prevents their division.
Participants are randomised to decide which treatment regimen they have. You can’t choose which treatment you have and neither can your doctor. You are told which treatment you are having and given information about it.
Ibrutinib and rituximab (IR) group
Ibrutinib is given as a capsule once every day that you are in the study (including the maintenance period and beyond) unless you stop responding to treatment or develop side effects bad enough to stop taking it.
Rituximab is given intravenously (through a drip into a vein) once every 3 or 4 weeks for 6 or 8 cycles (treatments). Afterwards, you are given maintenance rituximab every 2 months for up to 2 years, either intravenously or by subcutaneous (under the skin) injection.
Rituximab and chemotherapy group
Your doctor can choose which of the following chemo-immunotherapy regimens might be best for you:
- rituximab with bendamustine chemotherapy, given every 4 weeks for up to 6 cycles
- rituximab with CHOP chemotherapy (cyclophosphamide, doxorubicin (or hydroxydaunorubicin), vincristine and prednisolone), given every 3 weeks for up to 8 cycles.
In each cycle of treatment, you have drugs on some days, followed by a rest period to allow your body to recover before the next cycle. The chemotherapy drugs and rituximab are given intravenously. After you have completed chemo-immunotherapy, you are given maintenance rituximab every 2 months for up to 2 years, either intravenously or by subcutaneous (under the skin) injection.
Who can enter
Your consultant can give you advice on whether this trial might be suitable for you.
Around 400 people are needed for this trial.
You may be able to enter if:
- You have stage 2-4 mantle cell lymphoma.
- You haven’t had treatment for mantle cell lymphoma except radiotherapy or up to 1 week of steroids if intended only to control your symptoms.
- Your lymphoma is measurable by the tests used in the trial.
- You are well enough to look after yourself and up and about more than 50% of your waking hours, even if you are not well enough to work.
- Your blood test results are satisfactory.
- You are 60 or over.
You will not be able to enter if:
- Your doctor thinks you are fit enough to have a stem cell transplant.
- You have any health problems that your doctor thinks might make it unsafe for you to have the trial treatment.
- You’ve had a previous cancer in the last 2 years, unless it was one of a group of certain localised cancers.
- You are being treated with an investigational drug.
- You’ve had major surgery within 2 weeks prior to starting trial treatment.
- You’ve had a live vaccine within 4 weeks before starting trial treatment.
- You are HIV positive or have hepatitis C or hepatitis B.
- You need treatment for an infection.
More information about this trial is available at Cancer Research UK.