Purpose of trial
The aim of this trial is to see if the combination of lenalidomide and a new antibody treatment called MOR00208 can help people with diffuse large B-cell lymphoma (DLBCL).
Lenalidomide is a newer, targeted drug that is starting to be used for some people with lymphoma. MOR00208 is an experimental treatment. It is an antibody that targets a protein called CD19 found on B lymphocytes (B cells) . In this trial, MOR00208 is combined with lenalidomide to see if this regimen is safe and effective for people with DLBCL who need more treatment but cannot have a stem cell transplant.
Treatment is given in 4-week cycles. Everyone in this trial receives both lenalidomide and MOR00208:
- Lenalidomide is taken once a day by mouth for 3 weeks of every 4-week cycle.
- MOR00208 is given by intravenous infusion (into a vein) once a week for the first 3 cycles then once every 2 weeks.
You can have up to 12 cycles of lenalidomide and up to 24 cycles of MOR00208.
Who can enter
The trial team at one of the hospitals mentioned below can advise you whether you are suitable for this trial and whether any other conditions or treatments you have or have had prevent you from entering the trial.
Around 80 people are needed for this trial.
You may be able to enter if:
- You have DLBCL that has relapsed (come back) or is refractory (not responding to treatment).
- You have had 1–3 previous systemic (whole-body) treatment for DLBCL including a CD20 antibody (eg rituximab).
- A sample of your biopsy is available for tests.
- Your lymphoma is measurable by the tests used in the trial.
- You are well enough to look after yourself and are up and about more than 50% of your waking hours, even if you are not well enough to work.
- You are not able to have high-dose chemotherapy and an autologous stem cell transplant or you are not willing to do so.
- You and your partner are willing to use reliable contraception if there is any chance of you or your partner becoming pregnant.
- Your blood and other health test results are satisfactory.
- You are over 18.
You will not be able to enter if:
- You have a type of lymphoma other than DLBCL.
- Your DLBCL didn’t respond well to your first treatment (primary refractory).
- You have double-hit or triple-hit lymphoma (your lymphoma cells have 2 or more major changes to the genes).
- Your lymphoma is in your central nervous system (CNS; brain and spinal cord) or was in your CNS in the past.
- You’ve had other treatment in the 14 days before starting the trial treatment, including anti-cancer treatment, a major surgery, a live vaccine or intravenous antibiotics for an infection.
- You have been treated with a similar drug before, including anti-CD19 antibodies or thalidomide.
- You’ve had an autologous stem cell transplant in the last 3 months.
- You’ve ever had an allogeneic stem cell transplant.
- You’ve had deep vein thrombosis (DVT)/an embolism (blockage of a blood vessel) in the past and you are not willing or able to take medication to prevent a similar problem during the whole treatment period.
- You are participating in a clinical trial of another experimental treatment.
- You have HIV (if already known), Hepatitis B virus or Hepatitis C virus.
- You have had another cancer in the last 5 years (this has certain exceptions – the trial team can advise if this applies to you).
- You have any other health problems that your doctor thinks make it unsafe for you to take part in the trial.
More information about this trial is available at clinicaltrials.gov.