Purpose of trial
The aims of the trial are:
- To find out how effective ibrutinib is when combined with lenalidomide and rituximab in people with relapsed or refractory DLBCL of a non-GCB subtype.
- To find out the possible side effects of this regimen (combination of drugs)
DLBCL is usually treated with chemo-immunotherapy (chemotherapy with antibody therapy). If it comes back (relapses) or doesn’t respond to treatment (is refractory), it may be treated with high-dose chemotherapy and a stem cell transplant. Not everyone is fit enough for such intensive therapy.
Several subtypes of DLBCL can be detected in tests on cells from a biopsy. These subtypes are usually grouped as:
- germinal centre B-cell-like (GCB) subtype
- non-GCB subtype, which includes people with activated B-cell-like (ABC) subtype.
This trial is only enrolling people with the non-GCB subtype, which some studies suggest is more difficult to treat than the GCB subtype.
Previous trials suggested that people with non-GCB subtypes might respond well to lenalidomide and ibrutinib. It is hoped that the combination tested in this trial will improve outcomes for people with the non-GCB subtype of DLBCL.
Lenalidomide and ibrutinib are newer targeted therapies that are starting to be used for some people with lymphoma.
Rituximab is an antibody therapy that is already used in combination with chemotherapy for many people with DLBCL.
This trial is in 2 parts.
- Part 1 is to find the best dose of lenalidomide to use in combination with rituximab and ibrutinib for people with the non-GCB subtype of DLBCL. This part is open in the USA only.
- Part 2 is now recruiting participants in the UK and other parts of the world. This part of the trial is to test how well the best dose of lenalidomide works in combination with rituximab and ibrutinib. People entering this part of the trial all have the same doses of study drugs.
You have rituximab intravenously (through a drip into a vein).
You take ibrutinib and lenalidomide as oral capsules.
You have treatment in 4-weekly cycles. In each cycle, you have:
- rituximab on day 1 of each cycle for the first 6 cycles
- lenalidomide every day for the first 3 weeks of each cycle
- ibrutinib every day for all 4 weeks of each cycle.
You have up to 6 cycles of rituximab but can continue treatment with lenalidomide and ibrutinib as long as the treatment is benefitting you. You stop this treatment if your lymphoma gets worse or you develop side effects that are bad enough to make you stop it.
Who can enter
Your consultant can give you advice on whether this trial might be suitable for you.
Around 55 people are needed for this trial.
You may be able to enter if:
- You have DLBCL that is non-GCB subtype (ask your doctor if this applies to you).
- Your lymphoma has relapsed after or was refractory to a previous treatment.
- You are not able to have a stem cell transplant 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.
- You and your partner are willing to use reliable contraception for at least a month before treatment starts, during treatment and for at least a year after treatment has finished if there is any chance of you or your partner becoming pregnant.
- Your blood and organ test results are satisfactory.
- You are 18 or over.
You will not be able to enter if:
- Your lymphoma is in your central nervous system (CNS; brain and spinal cord).
- You have had a allogeneic stem cell or organ transplant.
- You have been treated with chemotherapy, radiotherapy or anti-cancer antibody therapy within the 14 days before you start trial treatment.
- You have been treated with radioimmunotherapy or antibody-toxin conjugates within the 10 weeks before you start trial treatment.
- You have been treated with ibrutinib or lenalidomide before.
- You are currently taking part in another treatment trial.
More information about this trial is available at clinicaltrials.gov.